Maetrics, LLC
Industry: Company
DescriptionFounded: 1984 Subsidiary: Maetrics Ltd.
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Maetrics, LLC Employees
Employee
Years
Job
Industry
Terry Frederick Terry Frederick's Maetrics, LLC Experience 2006 - 2008
Job Retired
Industry Pharmaceuticals
Experience
Retired December 2014 - Present
Semi-Retired November 2013 - Present
Confidential Client May 2013 - November 2013
21st Century Healthcare 2011 - 2012
Naturally Vitamins, Marlyn Nutraceuticals 2009 - 2010
ProPharma Group 2009 - 2009
Maetrics, LLC 2006 - 2008
Life Sciences International 2005 - 2006
Watson Pharmaceuticals 2002 - 2005
Day & Zimmermann September 1990 - June 2002
Skills
CAPA, GMP, FDA, Validation, Quality Assurance, Quality Control, Compliance, Change Control, Cleaning Validation, ISO 13485, Quality System, Biotechnology, Sterilization, 21 CFR Part 11, GxP, V&V, Sop, Pharmaceutical Industry, Pharmaceutics, Laboratory, Analytical Chemistry, Biopharmaceuticals, GLP, Quality Auditing, Regulatory Submissions, Technology Transfer, LIMS, HPLC, Chemistry, GAMP, Regulatory Affairs, Regulatory Requirements, Chromatography, Lifesciences, R&D, GCP, Formulation, Aseptic Processing, SOP development, Process Simulation, Computer System..., Vaccines, CRO, Clinical Trials, Microbiology, Pharmacovigilance, Quality Management, Contract Manufacturing, Commercialization, Clinical Development
Education
Drexel University 1966 — 1971
BS, Chemistry
Temple University
M.S Pharmaceutical Quality Assurance
Retired December 2014 - Present
Semi-Retired November 2013 - Present
Confidential Client May 2013 - November 2013
21st Century Healthcare 2011 - 2012
Naturally Vitamins, Marlyn Nutraceuticals 2009 - 2010
ProPharma Group 2009 - 2009
Maetrics, LLC 2006 - 2008
Life Sciences International 2005 - 2006
Watson Pharmaceuticals 2002 - 2005
Day & Zimmermann September 1990 - June 2002
Skills
CAPA, GMP, FDA, Validation, Quality Assurance, Quality Control, Compliance, Change Control, Cleaning Validation, ISO 13485, Quality System, Biotechnology, Sterilization, 21 CFR Part 11, GxP, V&V, Sop, Pharmaceutical Industry, Pharmaceutics, Laboratory, Analytical Chemistry, Biopharmaceuticals, GLP, Quality Auditing, Regulatory Submissions, Technology Transfer, LIMS, HPLC, Chemistry, GAMP, Regulatory Affairs, Regulatory Requirements, Chromatography, Lifesciences, R&D, GCP, Formulation, Aseptic Processing, SOP development, Process Simulation, Computer System..., Vaccines, CRO, Clinical Trials, Microbiology, Pharmacovigilance, Quality Management, Contract Manufacturing, Commercialization, Clinical Development
Education
Drexel University 1966 — 1971
BS, Chemistry
Temple University
M.S Pharmaceutical Quality Assurance
Edin Kahrimanovic Edin Kahrimanovic's Maetrics, LLC Experience March 2013 - Present
Job Consultant, Quality and Compliance at Maetrics, LLC
Industry Pharmaceuticals
Experience
Maetrics, LLC March 2013 - Present
Baxter Healthcare September 2012 - December 2012
Baxter Healthcare August 2011 - September 2012
Baxter Healthcare January 2011 - August 2011
Skills
Pharmaceutical Industry, Medical Devices, Regulatory Affairs, FDA, Sterilization, Pharmaceutical Sales, Clinical Research, Validation, Healthcare, Customer Service, Process Improvement, Research, Sop, SOP, GMP, Quality Assurance, Quality Management, Quality System, Software Documentation, CAPA
Education
Loyola University Chicago 2008 — 2011
Bachelor of Science, Health System Management
Maetrics, LLC March 2013 - Present
Baxter Healthcare September 2012 - December 2012
Baxter Healthcare August 2011 - September 2012
Baxter Healthcare January 2011 - August 2011
Skills
Pharmaceutical Industry, Medical Devices, Regulatory Affairs, FDA, Sterilization, Pharmaceutical Sales, Clinical Research, Validation, Healthcare, Customer Service, Process Improvement, Research, Sop, SOP, GMP, Quality Assurance, Quality Management, Quality System, Software Documentation, CAPA
Education
Loyola University Chicago 2008 — 2011
Bachelor of Science, Health System Management
April Baranowski April Baranowski's Maetrics, LLC Experience December 2012 - June 2014
Job Senior Associate, Quality Systems at Astellas Pharma
Industry Pharmaceuticals
Experience
Astellas Pharma October 2014 - Present
Validant August 2014 - October 2014
Maetrics, LLC December 2012 - June 2014
Baxter Healthcare July 2011 - December 2012
Mote Marine Laboratory January 2011 - April 2011
Skills
FDA, Medical Devices, Regulatory Affairs, Data Analysis, Change Control, Microsoft Office, Laboratory Equipment, Process Improvement, PowerPoint, Research, V&V, ISO 13485, Complaint Processing, MDR, FDA GMP, Adverse Event Reporting, 21 CFR Part 11, CAPA, Product Surveillance, Necropsy, Marine Mammals, Specimen Collection, Quality Consulting, Customer Support, Lean Process Improvement, Lean Projects, Quality Auditing, Technical Writing, Strategic Policy..., Reports, Healthcare Consulting, Quality Assurance, Quality Control, ISO 14971, Root Cause Analysis, Quality System
Education
St. Mary-of-the-Woods College 2007 — 2011
BS, Biology
Astellas Pharma October 2014 - Present
Validant August 2014 - October 2014
Maetrics, LLC December 2012 - June 2014
Baxter Healthcare July 2011 - December 2012
Mote Marine Laboratory January 2011 - April 2011
Skills
FDA, Medical Devices, Regulatory Affairs, Data Analysis, Change Control, Microsoft Office, Laboratory Equipment, Process Improvement, PowerPoint, Research, V&V, ISO 13485, Complaint Processing, MDR, FDA GMP, Adverse Event Reporting, 21 CFR Part 11, CAPA, Product Surveillance, Necropsy, Marine Mammals, Specimen Collection, Quality Consulting, Customer Support, Lean Process Improvement, Lean Projects, Quality Auditing, Technical Writing, Strategic Policy..., Reports, Healthcare Consulting, Quality Assurance, Quality Control, ISO 14971, Root Cause Analysis, Quality System
Education
St. Mary-of-the-Woods College 2007 — 2011
BS, Biology
Crystle Smith Crystle Smith's Maetrics, LLC Experience March 2012 - September 2014
Job Quallity Assurance Consultant
Industry Consumer Goods
Experience
Maetrics, LLC March 2012 - September 2014
Omnicare Inc. November 2011 - April 2013
Careers Express, Inc. October 2011 - April 2013
Skills
Medical Devices, Medical Compliance, Global Regulatory..., Oral & Written..., Technical Writing, Data Entry, Database Administration, Office Administration, Project Support, Highly motivated..., Team Leadership, Employee Training, Document Management, Process Implementation, Customer Service, Software Documentation, Quality Assurance, Training, Cross-functional Team..., Management, Quality Management
Education
Indiana University of Pennsylvania 2006 — 2009
Bachelor's of Science, Communications Media
Maetrics, LLC March 2012 - September 2014
Omnicare Inc. November 2011 - April 2013
Careers Express, Inc. October 2011 - April 2013
Skills
Medical Devices, Medical Compliance, Global Regulatory..., Oral & Written..., Technical Writing, Data Entry, Database Administration, Office Administration, Project Support, Highly motivated..., Team Leadership, Employee Training, Document Management, Process Implementation, Customer Service, Software Documentation, Quality Assurance, Training, Cross-functional Team..., Management, Quality Management
Education
Indiana University of Pennsylvania 2006 — 2009
Bachelor's of Science, Communications Media
Debbie Devine Debbie Devine's Maetrics, LLC Experience June 2013 - Present
Job Executive Administrative Assistant at Maetrics, LLC
Industry Medical Devices
Experience
Maetrics, LLC June 2013 - Present
Cornucopia Catering, Inc. June 2012 - June 2013
Thomas Medical Products, a GE Healthcare Company December 2006 - June 2012
ITandT Travel Solutions February 2003 - November 2006
Digital Equipment Corporation September 1985 - March 1988
Sealed Air Corporation 1979 - 1982
Skills
Customer Service, PowerPoint, Medical Devices, Microsoft Office, Accounts Receivable, Quality Assurance, Sales, Product Development, Microsoft Word, Microsoft Excel, Events Coordination, Invoicing, Account Management, Global Travel Management, Onboarding, Accounts Payable, Six Sigma, Process Improvement, Management
Education
The Ohio State University 1974 — 1977
Communications
Maetrics, LLC June 2013 - Present
Cornucopia Catering, Inc. June 2012 - June 2013
Thomas Medical Products, a GE Healthcare Company December 2006 - June 2012
ITandT Travel Solutions February 2003 - November 2006
Digital Equipment Corporation September 1985 - March 1988
Sealed Air Corporation 1979 - 1982
Skills
Customer Service, PowerPoint, Medical Devices, Microsoft Office, Accounts Receivable, Quality Assurance, Sales, Product Development, Microsoft Word, Microsoft Excel, Events Coordination, Invoicing, Account Management, Global Travel Management, Onboarding, Accounts Payable, Six Sigma, Process Improvement, Management
Education
The Ohio State University 1974 — 1977
Communications
Imran Asghar, P.Eng Imran Asghar, P.Eng's Maetrics, LLC Experience April 2014 - Present
Job Senior Compliance & Quality Engineer
Industry Pharmaceuticals
Experience
MAETRICS LLC April 2014 - Present
PHYTON BIOTECH (A DFB Company) March 2010 - April 2014
DPT Laboratories August 2007 - February 2010
Skills
Cost Control, Project Management, Quality Management, Root Cause Analysis, Software Documentation, Engineering, Process Simulation, Commissioning, Auditing, Cross-functional Team..., Validation, GMP, Sop, FDA, Quality Assurance, Change Control, Pharmaceutical Industry, Quality System, Biotechnology, CAPA, Technology Transfer, V&V, GLP, Quality Control, Manufacturing
Education
Colorado State University-Global Campus 2010 — 2014
Master's degree
University of Karachi 1990 — 2004
Master's degree
MAETRICS LLC April 2014 - Present
PHYTON BIOTECH (A DFB Company) March 2010 - April 2014
DPT Laboratories August 2007 - February 2010
Skills
Cost Control, Project Management, Quality Management, Root Cause Analysis, Software Documentation, Engineering, Process Simulation, Commissioning, Auditing, Cross-functional Team..., Validation, GMP, Sop, FDA, Quality Assurance, Change Control, Pharmaceutical Industry, Quality System, Biotechnology, CAPA, Technology Transfer, V&V, GLP, Quality Control, Manufacturing
Education
Colorado State University-Global Campus 2010 — 2014
Master's degree
University of Karachi 1990 — 2004
Master's degree
Erin Wujek's Maetrics, LLC Experience November 2012 - September 2014
Job Principal Consultant and Owner, CAPA SME
Industry Medical Devices
Experience
Barile and Associates, Inc February 2015 - Present
BioMed Solutions LLC February 2015 - Present
ConvaTec October 2014 - February 2015
Maetrics, LLC November 2012 - September 2014
Cook Endoscopy November 2010 - November 2012
Zimmer Surgical May 2010 - October 2010
Teleflex Medical October 2008 - May 2010
ConMed Linvatec February 2008 - October 2008
Arthrex, Inc April 2004 - November 2006
Skills
Medical Devices, ISO 13485, Quality System, CAPA, Root Cause Analysis, FDA, 21 CFR, Minitab, R, Biomedical Engineering, Injection Molding, Orthopedic, Biomaterials, GMP, V&V, Quality Control, Sop, Manufacturing, Six Sigma, Solidworks, Design Control, SOP, SolidWorks
Education
The University of Akron 1999 — 2003
BS, Biomedical Engineering
Barile and Associates, Inc February 2015 - Present
BioMed Solutions LLC February 2015 - Present
ConvaTec October 2014 - February 2015
Maetrics, LLC November 2012 - September 2014
Cook Endoscopy November 2010 - November 2012
Zimmer Surgical May 2010 - October 2010
Teleflex Medical October 2008 - May 2010
ConMed Linvatec February 2008 - October 2008
Arthrex, Inc April 2004 - November 2006
Skills
Medical Devices, ISO 13485, Quality System, CAPA, Root Cause Analysis, FDA, 21 CFR, Minitab, R, Biomedical Engineering, Injection Molding, Orthopedic, Biomaterials, GMP, V&V, Quality Control, Sop, Manufacturing, Six Sigma, Solidworks, Design Control, SOP, SolidWorks
Education
The University of Akron 1999 — 2003
BS, Biomedical Engineering
Steven Nieves PMP, PMI-ACP, ITIL, MSCS Steven Nieves PMP, PMI-ACP, ITIL, MSCS's Maetrics, LLC Experience June 2014 - June 2015
Job Senior IT Project Manager
Industry Management Consulting
Experience
Royal Caribbean Cruises, Ltd. June 2015 - September 2015
MAETRICS, LLC June 2014 - June 2015
Kforce Global Solutions, Inc. October 2013 - June 2014
EduK Group November 2011 - October 2013
National University College November 2010 - October 2013
Abbott Laboratories January 2007 - November 2011
Abbott Laboratories January 2002 - December 2007
Skills
Customer Service, Change Management, College Teaching, Computer System..., Technical Writing, Software Project..., System Administration, Virtualization, VMware ESX, SDLC, LIMS, PMP, ITIL, Certified Project..., Network Security, Windows Server, Network Administration, Server Administration, Disaster Recovery, Business Analysis, Computer Forensics, Information Assurance, Data Mining, Database Administration, Quality Assurance, Risk Assessment, Virtual Teams, Risk Management, Computer Network..., Project Management, Visio, IT Service Management, Requirements Analysis, Process Improvement, MS Project, InfinityQS, SPC charts, Continuous Process..., Soft Skills, Business Impact Analysis, Waterfall, MES, Training & Development, Network Operations, IT Asset Management, Decommissioning, Weka, Conflict Management, RUP Methodologies, Extreme Programming
Education
Universidad Politécnica de Puerto Rico 2005 — 2010
M.S, Computer Science - Knowledge Discovery and Data Mining
Inter-American University of Puerto Rico-Arecibo Campus 2000 — 2004
BS, Computer Science
Royal Caribbean Cruises, Ltd. June 2015 - September 2015
MAETRICS, LLC June 2014 - June 2015
Kforce Global Solutions, Inc. October 2013 - June 2014
EduK Group November 2011 - October 2013
National University College November 2010 - October 2013
Abbott Laboratories January 2007 - November 2011
Abbott Laboratories January 2002 - December 2007
Skills
Customer Service, Change Management, College Teaching, Computer System..., Technical Writing, Software Project..., System Administration, Virtualization, VMware ESX, SDLC, LIMS, PMP, ITIL, Certified Project..., Network Security, Windows Server, Network Administration, Server Administration, Disaster Recovery, Business Analysis, Computer Forensics, Information Assurance, Data Mining, Database Administration, Quality Assurance, Risk Assessment, Virtual Teams, Risk Management, Computer Network..., Project Management, Visio, IT Service Management, Requirements Analysis, Process Improvement, MS Project, InfinityQS, SPC charts, Continuous Process..., Soft Skills, Business Impact Analysis, Waterfall, MES, Training & Development, Network Operations, IT Asset Management, Decommissioning, Weka, Conflict Management, RUP Methodologies, Extreme Programming
Education
Universidad Politécnica de Puerto Rico 2005 — 2010
M.S, Computer Science - Knowledge Discovery and Data Mining
Inter-American University of Puerto Rico-Arecibo Campus 2000 — 2004
BS, Computer Science
D.C. Smalley's Maetrics, LLC Experience 2006 - 2007
Job Account Manager SanDisk
Industry Semiconductors
Experience
SanDisk December 2013 - Present
Victory Sales, Inc. June 2007 - December 2013
Maetrics, LLC 2006 - 2007
Bechtel Bettis Atomic Power Laboratory 2005 - 2006
Skills
Semiconductor Industry
Education
Rose-Hulman Institute of Technology 1996 — 2001
Electrical Engineering, Telecomm, Power Dist, Networking
SanDisk December 2013 - Present
Victory Sales, Inc. June 2007 - December 2013
Maetrics, LLC 2006 - 2007
Bechtel Bettis Atomic Power Laboratory 2005 - 2006
Skills
Semiconductor Industry
Education
Rose-Hulman Institute of Technology 1996 — 2001
Electrical Engineering, Telecomm, Power Dist, Networking
Donald Whitman Donald Whitman's Maetrics, LLC Experience September 2012 - May 2014
Job Remediation Complaints/Reporting Specialist at EG Life Sciences
Industry Medical Devices
Experience
EG Life Sciences June 2015 - Present
NovusLife, LLC September 2014 - April 2015
R&Q May 2014 - September 2014
Maetrics, LLC September 2012 - May 2014
Medtronic September 2011 - June 2012
Nassau County School Board August 2006 - June 2010
Hampton Inn and Suites - Pigeon Forge July 2005 - April 2006
Nassau County School Board August 2003 - June 2005
Hampton Inn & Suites 2002 - 2003
Skills
Complaints, Product Complaints, Complaint Investigations, MDR, Remediation, Trackwise, SAP, Compliance, Complaint Management, CAPA, FDA, Quality System, Validation, GMP, ISO 13485, 21 CFR Part 11, Medical Devices, Quality Assurance, Quality Auditing, Quality Control, Regulatory Affairs, Software Documentation, Quality Management, V&V
Education
University of North Florida 1998 — 2003
Bachelor of Arts (B.A.), Elementary Education and Teaching, 3.5
Florida State College at Jacksonville 1999 — 2001
Associate of Arts (A.A.), Elementary Education and Teaching, 4.0
EG Life Sciences June 2015 - Present
NovusLife, LLC September 2014 - April 2015
R&Q May 2014 - September 2014
Maetrics, LLC September 2012 - May 2014
Medtronic September 2011 - June 2012
Nassau County School Board August 2006 - June 2010
Hampton Inn and Suites - Pigeon Forge July 2005 - April 2006
Nassau County School Board August 2003 - June 2005
Hampton Inn & Suites 2002 - 2003
Skills
Complaints, Product Complaints, Complaint Investigations, MDR, Remediation, Trackwise, SAP, Compliance, Complaint Management, CAPA, FDA, Quality System, Validation, GMP, ISO 13485, 21 CFR Part 11, Medical Devices, Quality Assurance, Quality Auditing, Quality Control, Regulatory Affairs, Software Documentation, Quality Management, V&V
Education
University of North Florida 1998 — 2003
Bachelor of Arts (B.A.), Elementary Education and Teaching, 3.5
Florida State College at Jacksonville 1999 — 2001
Associate of Arts (A.A.), Elementary Education and Teaching, 4.0
Dawn Lucy Stone Radulic Dawn Lucy Stone Radulic's Maetrics, LLC Experience February 2013 - November 2014
Job Senior Product Safety Clinician at Codman Neurovascular
Industry Medical Devices
Experience
Codman Neurovascular November 2014 - Present
Maetrics, LLC February 2013 - November 2014
Cordis December 2010 - November 2014
St Mary's Medical Center 2010 - February 2013
Holy Cross Hospital October 1998 - April 2008
Skills
Complaints, Safety Management..., Cardio, Interventional Radiology, Patient Safety, ISO 13485, ISO 14971, FDA, Medical Devices, Cath Lab, Complaint Management, Hospitals, Software Documentation, Design Control, Healthcare, CAPA, Vascular, Quality Assurance, Quality System, Clinical Research, Nursing, Pharmaceutical Industry, GMP, Validation
Education
Barry University 1983 — 1987
BSN, Nursing Science
Codman Neurovascular November 2014 - Present
Maetrics, LLC February 2013 - November 2014
Cordis December 2010 - November 2014
St Mary's Medical Center 2010 - February 2013
Holy Cross Hospital October 1998 - April 2008
Skills
Complaints, Safety Management..., Cardio, Interventional Radiology, Patient Safety, ISO 13485, ISO 14971, FDA, Medical Devices, Cath Lab, Complaint Management, Hospitals, Software Documentation, Design Control, Healthcare, CAPA, Vascular, Quality Assurance, Quality System, Clinical Research, Nursing, Pharmaceutical Industry, GMP, Validation
Education
Barry University 1983 — 1987
BSN, Nursing Science
Lynelle Martinez Lynelle Martinez's Maetrics, LLC Experience August 2011 - Present
Job Consultant at Maetrics, LLC
Industry Management Consulting
Experience
Maetrics, LLC August 2011 - Present
Beckman Coulter 2014 - 2015
Beckman Coulter 2014 - 2015
Boston Scientific 2000 - 2013
Skills
Medical Devices, Quality System, Quality Assurance, FDA, Validation, Pharmaceutical Industry, Software Documentation, Cross-functional Team..., Process Improvement, ISO 13485, CAPA, Design Control, Management, Strategic Planning, Training, 21 CFR Part 11, R&D
Education
University of Phoenix 2005 — 2007
Master of Business Administration (MBA), Business Administration and Management, General
Metropolitan State University 1995 — 2001
Bachelor of Arts (B.A.), Technical and Scientific Communication
Lake Superior College 1985 — 1986
Associate in Applied Sciences (A.A.), Nursing Practice
Maetrics, LLC August 2011 - Present
Beckman Coulter 2014 - 2015
Beckman Coulter 2014 - 2015
Boston Scientific 2000 - 2013
Skills
Medical Devices, Quality System, Quality Assurance, FDA, Validation, Pharmaceutical Industry, Software Documentation, Cross-functional Team..., Process Improvement, ISO 13485, CAPA, Design Control, Management, Strategic Planning, Training, 21 CFR Part 11, R&D
Education
University of Phoenix 2005 — 2007
Master of Business Administration (MBA), Business Administration and Management, General
Metropolitan State University 1995 — 2001
Bachelor of Arts (B.A.), Technical and Scientific Communication
Lake Superior College 1985 — 1986
Associate in Applied Sciences (A.A.), Nursing Practice
Adam Ritter's Maetrics, LLC Experience 2011 - 2013
Job Director of Talent Management at Flexware Innovation
Industry Staffing and Recruiting
Experience
Flexware Innovation April 2014 - September 2014
Theoris Engineering / Theoris Scientific, a Division of Theoris Engineering September 2011 - April 2013
Maetrics, LLC 2011 - 2013
ProfyleTracker March 2010 - September 2011
General Motors January 2007 - January 2010
Skills
Contract Recruitment, Permanent Placement, Manufacturing, Aerospace, Automotive, Electronics, Vertical Marketing, Defense, Technical Recruiting, Applicant Tracking..., Talent Acquisition, Sourcing, Recruiting, Internet Recruiting, College Recruiting
Education
Indiana University Bloomington
Flexware Innovation April 2014 - September 2014
Theoris Engineering / Theoris Scientific, a Division of Theoris Engineering September 2011 - April 2013
Maetrics, LLC 2011 - 2013
ProfyleTracker March 2010 - September 2011
General Motors January 2007 - January 2010
Skills
Contract Recruitment, Permanent Placement, Manufacturing, Aerospace, Automotive, Electronics, Vertical Marketing, Defense, Technical Recruiting, Applicant Tracking..., Talent Acquisition, Sourcing, Recruiting, Internet Recruiting, College Recruiting
Education
Indiana University Bloomington
Scott Clayson Scott Clayson's Maetrics, LLC Experience October 2006 - November 2008
Job Senior Validation Analyst/LIMS Administrator at Zimmer
Industry Medical Devices
Experience
Zimmer November 2008 - Present
Maetrics, LLC October 2006 - November 2008
Boston Scientific October 2006 - December 2007
Allergan 2005 - 2006
Stelex 2004 - 2006
Ethicon 1995 - 2004
Skills
V&V, Medical Devices, Validation, LIMS, Process Improvement, Continuous Improvement, Management, SPC, Computer System..., FDA, Quality System, ISO 13485, CAPA, GMP, Manufacturing, 21 CFR Part 11, Sop, Quality Assurance, Change Control, FMEA
Education
Angelo State University 1999 — 2002
BBA, Management Information Systems
Texas Tech University 1996 — 1997
Electrical Engineering/Computer Science
Zimmer November 2008 - Present
Maetrics, LLC October 2006 - November 2008
Boston Scientific October 2006 - December 2007
Allergan 2005 - 2006
Stelex 2004 - 2006
Ethicon 1995 - 2004
Skills
V&V, Medical Devices, Validation, LIMS, Process Improvement, Continuous Improvement, Management, SPC, Computer System..., FDA, Quality System, ISO 13485, CAPA, GMP, Manufacturing, 21 CFR Part 11, Sop, Quality Assurance, Change Control, FMEA
Education
Angelo State University 1999 — 2002
BBA, Management Information Systems
Texas Tech University 1996 — 1997
Electrical Engineering/Computer Science
Gary Cehelsky Gary Cehelsky's Maetrics, LLC Experience September 2013 - March 2014
Job Embedded Software Engineer, ETAS Inc.
Industry Medical Devices
Experience
ETAS November 2014 - Present
Aerotech, Inc. April 2014 - November 2014
Maetrics, LLC September 2013 - March 2014
Validant April 2011 - July 2013
Baxter International Inc. August 2006 - March 2011
Intel Corporation January 2001 - August 2006
Be Free, Inc January 2000 - July 2000
Bell and Howell May 1998 - January 2000
Chiron Corporation January 1994 - May 1998
Space Systems Loral January 1991 - January 1994
Skills
Quality Assurance, Engineering, Integration, CAPA, Embedded Software, Quality System, V&V, Testing, FDA, Change Control, Validation, ISO 13485, ISO 14971, 21 CFR Part 11, Process Simulation, R&D, Design Control, Computer System..., Medical Devices, Software Quality..., GxP, ISO, Quality Control, Sop, DMAIC, Design of Experiments, Software Documentation, Quality Auditing, GMP, Root Cause Analysis, Quality Management, GAMP, FMEA, Regulatory Affairs, Document Management, LIMS, Regulatory Requirements, Regulatory Submissions, Technology Transfer, GLP, SOP
Education
Slippery Rock University of Pennsylvania 1977 — 1980
Bachelor of Science (BS), Mathematics
University of Southern California
Post Grad Studies, Management Information Systems and Services
Case Western Reserve University
Computer Software Engineering
ETAS November 2014 - Present
Aerotech, Inc. April 2014 - November 2014
Maetrics, LLC September 2013 - March 2014
Validant April 2011 - July 2013
Baxter International Inc. August 2006 - March 2011
Intel Corporation January 2001 - August 2006
Be Free, Inc January 2000 - July 2000
Bell and Howell May 1998 - January 2000
Chiron Corporation January 1994 - May 1998
Space Systems Loral January 1991 - January 1994
Skills
Quality Assurance, Engineering, Integration, CAPA, Embedded Software, Quality System, V&V, Testing, FDA, Change Control, Validation, ISO 13485, ISO 14971, 21 CFR Part 11, Process Simulation, R&D, Design Control, Computer System..., Medical Devices, Software Quality..., GxP, ISO, Quality Control, Sop, DMAIC, Design of Experiments, Software Documentation, Quality Auditing, GMP, Root Cause Analysis, Quality Management, GAMP, FMEA, Regulatory Affairs, Document Management, LIMS, Regulatory Requirements, Regulatory Submissions, Technology Transfer, GLP, SOP
Education
Slippery Rock University of Pennsylvania 1977 — 1980
Bachelor of Science (BS), Mathematics
University of Southern California
Post Grad Studies, Management Information Systems and Services
Case Western Reserve University
Computer Software Engineering
Kelley Krisch Kelley Krisch's Maetrics, LLC Experience August 2013 - January 2014
Job Experienced Quality Engineer, Medical Device
Industry Medical Devices
Experience
SQA Services, Inc. April 2015 - Present
Stryker Sustainability Solutions March 2014 - December 2014
Maetrics, LLC August 2013 - January 2014
Abbott Vascular August 2012 - April 2013
Hospira November 2011 - July 2012
Abbott Diabetes Care January 2011 - October 2011
CACI International Inc June 2008 - June 2009
TAC Worldwide/BAE Systems June 2007 - June 2008
BAE Systems January 2006 - June 2007
Parker Hannifin May 2002 - May 2005
Skills
ISO9001, AS9100, ISO13485, Microsoft Office, Root Cause Analysis, RAB certified QMS..., GD&T, Blueprint reading, ISO 20000, DOE, SPC, TQM, OSHA safety, Environmental Compliance, Kaizen, Lean Manufacturing, ITIL version 3, Quality Assurance, FAR145, JAA/EASA, CAAC, Project management, Iso 9000, Design of Experiments, ISO 13485, FDA, Project Management, V&V, Quality Control, ISO 9000, Quality System, CAPA, Validation
Education
Cleveland State University 1983 — 1988
B.S., Chemical Engineering
Cleveland State University
B.S. Chemical Engineering
SQA Services, Inc. April 2015 - Present
Stryker Sustainability Solutions March 2014 - December 2014
Maetrics, LLC August 2013 - January 2014
Abbott Vascular August 2012 - April 2013
Hospira November 2011 - July 2012
Abbott Diabetes Care January 2011 - October 2011
CACI International Inc June 2008 - June 2009
TAC Worldwide/BAE Systems June 2007 - June 2008
BAE Systems January 2006 - June 2007
Parker Hannifin May 2002 - May 2005
Skills
ISO9001, AS9100, ISO13485, Microsoft Office, Root Cause Analysis, RAB certified QMS..., GD&T, Blueprint reading, ISO 20000, DOE, SPC, TQM, OSHA safety, Environmental Compliance, Kaizen, Lean Manufacturing, ITIL version 3, Quality Assurance, FAR145, JAA/EASA, CAAC, Project management, Iso 9000, Design of Experiments, ISO 13485, FDA, Project Management, V&V, Quality Control, ISO 9000, Quality System, CAPA, Validation
Education
Cleveland State University 1983 — 1988
B.S., Chemical Engineering
Cleveland State University
B.S. Chemical Engineering
Layla (Ramsey) Chambers RT(R)(M)'s Maetrics, LLC Experience March 2013 - December 2014
Job Compliance & Quality Consultant at Maetrics, LLC
Industry Medical Devices
Experience
Aerotek April 2015 - Present
Maetrics, LLC March 2013 - December 2014
Alego Health October 2012 - November 2012
Adecco, Phillips Healthcare December 2011 - June 2012
South Pointe Hospital September 2000 - April 2010
MDX of Ohio September 1999 - July 2000
NCS Mobile Diagnostics June 1999 - September 1999
Solon Med Center September 1997 - June 1999
Dr. Shroyer April 1998 - January 1999
Marymount Hospital September 1994 - September 1997
Skills
Radiology, Radiography, Medical Devices, X-ray, EMR, ETQ, SAP, Trackwise, Hospitals, Healthcare, Microsoft Word, Microsoft Excel, Microsoft Office, OneNote, PowerPoint, Digital Radiography, Mammography, Public Speaking, MRI, Quality Assurance, Quality System, Medical Imaging, Presentations, Radiation Safety, Digital Imaging, Biomedical Engineering, Radiologic Technology, Interventional Radiology, Computed Radiography, Training, Nuclear Medicine, Troubleshooting, Emergency Medicine, RIS, Pediatrics, Computed Tomography, Angiography, Venipuncture, EKG, Problem Solving, Tomography, Fluoroscopy, Medicine, ARRT, Digital Mammography, C-arm, PACS, Surgery, FDA
Education
Adventist University 2014 — 2016
Bachelor of Radiologic Science
Medical Technology Management Institute 2003 — 2004
Diploma, Mammography Technician/Technology
Cuyahoga Community College 1994 — 1997
Associate of Science (AS), Radiologic Technology/Science - Radiographer
Kenston High School 1988 — 1991
Diploma, General Studies
Aerotek April 2015 - Present
Maetrics, LLC March 2013 - December 2014
Alego Health October 2012 - November 2012
Adecco, Phillips Healthcare December 2011 - June 2012
South Pointe Hospital September 2000 - April 2010
MDX of Ohio September 1999 - July 2000
NCS Mobile Diagnostics June 1999 - September 1999
Solon Med Center September 1997 - June 1999
Dr. Shroyer April 1998 - January 1999
Marymount Hospital September 1994 - September 1997
Skills
Radiology, Radiography, Medical Devices, X-ray, EMR, ETQ, SAP, Trackwise, Hospitals, Healthcare, Microsoft Word, Microsoft Excel, Microsoft Office, OneNote, PowerPoint, Digital Radiography, Mammography, Public Speaking, MRI, Quality Assurance, Quality System, Medical Imaging, Presentations, Radiation Safety, Digital Imaging, Biomedical Engineering, Radiologic Technology, Interventional Radiology, Computed Radiography, Training, Nuclear Medicine, Troubleshooting, Emergency Medicine, RIS, Pediatrics, Computed Tomography, Angiography, Venipuncture, EKG, Problem Solving, Tomography, Fluoroscopy, Medicine, ARRT, Digital Mammography, C-arm, PACS, Surgery, FDA
Education
Adventist University 2014 — 2016
Bachelor of Radiologic Science
Medical Technology Management Institute 2003 — 2004
Diploma, Mammography Technician/Technology
Cuyahoga Community College 1994 — 1997
Associate of Science (AS), Radiologic Technology/Science - Radiographer
Kenston High School 1988 — 1991
Diploma, General Studies
RJ Lemieux RJ Lemieux's Maetrics, LLC Experience 2013 - 2014
Job Founder & Managing Partner, Powder Point Ventures, LLC
Industry Management Consulting
Experience
Powder Point Ventures January 2015 - Present
Maetrics, LLC 2013 - 2014
RM Nephew & Associates 2012 - 2013
Ernst & Young 2011 - 2012
Ernst & Young 2007 - 2011
Ernst & Young 2006 - 2007
Corporate Executive Board 2005 - 2006
Thomson Reuters / Yankee Group 1999 - 2005
AT&T (Formerly SBC Communications) 1994 - 1999
Skills
Relationship Development, Thought Leadership, Competitive Intelligence, Corporate Development, Go-to-market Strategy, Team Leadership, Pursuit Excellence, Strategic Consulting, Strategic Planning, Business Strategy, New Business Development, Strategic Partnerships, Talent Acquisition, Contract Negotiation, CRM, Strategy, Start-ups, Business Development, Professional Services, Leadership, Management, Consulting, Management Consulting, Sales, Market Research, Marketing, Sales Operations, Cross-functional Team..., Sales Management, Financial Analysis, Business Process..., Process Improvement, Program Management, Marketing Strategy, Recruiting, Financial Services, Competitive Analysis, Due Diligence, SaaS, Accounting, Analytics, Product Management, Consultative Selling, Business Planning, Financial Modeling, Telecommunications, Financial Reporting, Business Analysis, Business Intelligence, Mergers & Acquisitions
Education
Bentley College - Elkin B. McCallum Graduate School of Business
MBA, Management & Entrepreneurial studies
Hobart and William Smith Colleges
BA, Political Science
Tabor Academy
Tabor Academy, High School/Secondary Diplomas and Certificates
Powder Point Ventures January 2015 - Present
Maetrics, LLC 2013 - 2014
RM Nephew & Associates 2012 - 2013
Ernst & Young 2011 - 2012
Ernst & Young 2007 - 2011
Ernst & Young 2006 - 2007
Corporate Executive Board 2005 - 2006
Thomson Reuters / Yankee Group 1999 - 2005
AT&T (Formerly SBC Communications) 1994 - 1999
Skills
Relationship Development, Thought Leadership, Competitive Intelligence, Corporate Development, Go-to-market Strategy, Team Leadership, Pursuit Excellence, Strategic Consulting, Strategic Planning, Business Strategy, New Business Development, Strategic Partnerships, Talent Acquisition, Contract Negotiation, CRM, Strategy, Start-ups, Business Development, Professional Services, Leadership, Management, Consulting, Management Consulting, Sales, Market Research, Marketing, Sales Operations, Cross-functional Team..., Sales Management, Financial Analysis, Business Process..., Process Improvement, Program Management, Marketing Strategy, Recruiting, Financial Services, Competitive Analysis, Due Diligence, SaaS, Accounting, Analytics, Product Management, Consultative Selling, Business Planning, Financial Modeling, Telecommunications, Financial Reporting, Business Analysis, Business Intelligence, Mergers & Acquisitions
Education
Bentley College - Elkin B. McCallum Graduate School of Business
MBA, Management & Entrepreneurial studies
Hobart and William Smith Colleges
BA, Political Science
Tabor Academy
Tabor Academy, High School/Secondary Diplomas and Certificates
Joseph Oshana Joseph Oshana's Maetrics, LLC Experience November 2012 - Present
Job Compliance & Quality Consultant at Maetrics, LLC
Industry Medical Devices
Experience
Maetrics, LLC November 2012 - Present
Baxter Healthcare July 2011 - November 2012
Illinois Democratic Coordinated Campaign September 2010 - December 2010
Loyola University Chicago July 2007 - May 2010
Skills
Product Surveillance, Regulatory Affairs, Pharmaceutical Industry, Medical Devices, Data Analysis, FDA, Molecular Biology, Life Sciences
Education
Loyola University of Chicago 2006 — 2010
B.S., Biology with molecular emphasis
Maetrics, LLC November 2012 - Present
Baxter Healthcare July 2011 - November 2012
Illinois Democratic Coordinated Campaign September 2010 - December 2010
Loyola University Chicago July 2007 - May 2010
Skills
Product Surveillance, Regulatory Affairs, Pharmaceutical Industry, Medical Devices, Data Analysis, FDA, Molecular Biology, Life Sciences
Education
Loyola University of Chicago 2006 — 2010
B.S., Biology with molecular emphasis
Brijesh Patel Brijesh Patel's Maetrics, LLC Experience September 2006 - June 2011
Job Regulatory Compliance Officer at Enhanced Compliance Inc. | Experts in Validation and FDA Compliance
Industry Medical Devices
Experience
Enhanced Compliance Inc June 2011 - Present
Synthes November 2010 - June 2011
Maetrics, LLC September 2006 - June 2011
Boston Scientific April 2008 - November 2010
Boston Scientific January 2007 - April 2008
Boston Scientific September 2006 - December 2006
Barr Laboratories June 2005 - September 2006
Abbott Laboratories 2004 - 2005
Skills
Design Control, Root Cause Analysis, Product Design, Gage R&R, Validation, Process Validation, QSR, 21 CFR Part 11, SOP, GMP, Medical Devices, Pharmaceuticals, CAPA, GLP, Quality Systems, Quality Assurance, cGMP, Compliance, ISO 13485, Documentation, ISO, Quality Management, Process Development, Validations, Cross-functional Team..., Quality Auditing, Process Improvement, Manufacturing, V&V, EN 60601-1, Quality System, Sop, Process Simulation, Document Management, Design of Experiments, Quality Control, R&D, ISO 14971, Regulatory Submissions, GAMP, Technology Transfer, Software Documentation, DMAIC, Clinical Development, Change Control, Six Sigma, SPC, Lifesciences, Clinical Trials, GCP
Education
Governors State University 2002 — 2004
B.S
Enhanced Compliance Inc June 2011 - Present
Synthes November 2010 - June 2011
Maetrics, LLC September 2006 - June 2011
Boston Scientific April 2008 - November 2010
Boston Scientific January 2007 - April 2008
Boston Scientific September 2006 - December 2006
Barr Laboratories June 2005 - September 2006
Abbott Laboratories 2004 - 2005
Skills
Design Control, Root Cause Analysis, Product Design, Gage R&R, Validation, Process Validation, QSR, 21 CFR Part 11, SOP, GMP, Medical Devices, Pharmaceuticals, CAPA, GLP, Quality Systems, Quality Assurance, cGMP, Compliance, ISO 13485, Documentation, ISO, Quality Management, Process Development, Validations, Cross-functional Team..., Quality Auditing, Process Improvement, Manufacturing, V&V, EN 60601-1, Quality System, Sop, Process Simulation, Document Management, Design of Experiments, Quality Control, R&D, ISO 14971, Regulatory Submissions, GAMP, Technology Transfer, Software Documentation, DMAIC, Clinical Development, Change Control, Six Sigma, SPC, Lifesciences, Clinical Trials, GCP
Education
Governors State University 2002 — 2004
B.S
Roberta L. Shirley CQA, CMQ/OE's Maetrics, LLC Experience February 2013 - March 2014
Job Sr. Software Application Engineer SME at Cardinal Health
Industry Medical Devices
Experience
Tek Systems -Cardinal Health May 2015 - Present
Baxter International Inc. March 2014 - Present
Aerotek March 2014 - Present
Private 2010 - 2015
Private 2010 - 2015
Private 2010 - 2015
Maetrics, LLC February 2013 - March 2014
Covidien September 2012 - February 2013
Teleflex Medical OEM May 2010 - August 2012
Maetrics, LLC September 2008 - April 2010
Skills
Quality System, CAPA, ISO 13485, FDA, Quality Management, Quality Assurance, Six Sigma, ISO, Quality Auditing, Supplier Quality, Validation, Manufacturing, Medical Devices, V&V, SPC, FMEA, Product Development, Computer System..., Process Improvement, Lean Manufacturing, Kaizen, Manufacturing..., 5S, Process Simulation, Cross-functional Team..., Auditing, Value Stream Mapping, Engineering, Calibration, Process Engineering, Inspection, Training, ISO 14971, APQP, Internal Audit, GD&T, Document Management, Measurement System..., Product Design, Leadership Development, Machining, New Business Development, Project Management, Global Customer Service, Compliance Remediation, Behavioral Interviewing, Packaging, Regulatory Affairs, Post Market Surveillance
Education
Indiana Institute of Technology
Bachelor of Science, Business Management
Tek Systems -Cardinal Health May 2015 - Present
Baxter International Inc. March 2014 - Present
Aerotek March 2014 - Present
Private 2010 - 2015
Private 2010 - 2015
Private 2010 - 2015
Maetrics, LLC February 2013 - March 2014
Covidien September 2012 - February 2013
Teleflex Medical OEM May 2010 - August 2012
Maetrics, LLC September 2008 - April 2010
Skills
Quality System, CAPA, ISO 13485, FDA, Quality Management, Quality Assurance, Six Sigma, ISO, Quality Auditing, Supplier Quality, Validation, Manufacturing, Medical Devices, V&V, SPC, FMEA, Product Development, Computer System..., Process Improvement, Lean Manufacturing, Kaizen, Manufacturing..., 5S, Process Simulation, Cross-functional Team..., Auditing, Value Stream Mapping, Engineering, Calibration, Process Engineering, Inspection, Training, ISO 14971, APQP, Internal Audit, GD&T, Document Management, Measurement System..., Product Design, Leadership Development, Machining, New Business Development, Project Management, Global Customer Service, Compliance Remediation, Behavioral Interviewing, Packaging, Regulatory Affairs, Post Market Surveillance
Education
Indiana Institute of Technology
Bachelor of Science, Business Management
Janet (Gilbert) Macones Janet (Gilbert) Macones's Maetrics, LLC Experience September 2008 - April 2009
Job Sr. Regulatory Affairs Quality Assurance Specialist at ImmunoScience, Inc.
Industry Biotechnology
Experience
ImmunoScience, Inc. November 2013 - Present
ImmunoScience, Inc. February 2013 - October 2013
CooperVision October 2011 - February 2013
ImmunoScience, Inc. April 2009 - October 2011
Maetrics, LLC September 2008 - April 2009
Smith & Nephew February 2007 - August 2008
AgaMatrix November 2005 - February 2007
Guidant (Boston Scientific, Now Abbott) January 2004 - August 2005
Philips November 1999 - December 2003
Skills
Quality Auditing, Leadership, Regulatory Affairs, Training, Quality Assurance, Medical Devices, CAPA, Project Management, Complaint Investigations, Compliance, MDRs, IVDD, IVD, Consulting, Design Control, FDA, CE marking, ISO 13485, Sop, Validation, Change Control, GMP, SOP, Quality System, Biotechnology, Cross-functional Team..., Pharmaceutical Industry, V&V, R&D, Regulatory Submissions, Management, Life Sciences
Education
BSI British Standards Institution
ISO 13485:2003 Lead Auditor (TPECS)
Ohlone College
English Language and Literature, General Graphic Design, Marketing
Silicon Valley University
Graphic Design, Desktop Publising
ImmunoScience, Inc. November 2013 - Present
ImmunoScience, Inc. February 2013 - October 2013
CooperVision October 2011 - February 2013
ImmunoScience, Inc. April 2009 - October 2011
Maetrics, LLC September 2008 - April 2009
Smith & Nephew February 2007 - August 2008
AgaMatrix November 2005 - February 2007
Guidant (Boston Scientific, Now Abbott) January 2004 - August 2005
Philips November 1999 - December 2003
Skills
Quality Auditing, Leadership, Regulatory Affairs, Training, Quality Assurance, Medical Devices, CAPA, Project Management, Complaint Investigations, Compliance, MDRs, IVDD, IVD, Consulting, Design Control, FDA, CE marking, ISO 13485, Sop, Validation, Change Control, GMP, SOP, Quality System, Biotechnology, Cross-functional Team..., Pharmaceutical Industry, V&V, R&D, Regulatory Submissions, Management, Life Sciences
Education
BSI British Standards Institution
ISO 13485:2003 Lead Auditor (TPECS)
Ohlone College
English Language and Literature, General Graphic Design, Marketing
Silicon Valley University
Graphic Design, Desktop Publising
Angela Graves's Maetrics, LLC Experience 2013 - August 2015
Job Complaint Analyst Mindlance
Industry Pharmaceuticals
Experience
Mindlance July 2015 - Present
Maetrics, LLC 2013 - August 2015
Roche Pharmaceuticals May 2006 - 2013
WJOB AM 1230 Hammond May 2005 - November 2005
Skills
Medical Devices, Quality Assurance, SAP, Call Centers, FDA, Microsoft Office, Pharmaceutical Industry, Process Improvement, Product Launch, Sop
Education
Indiana University Bloomington 2000 — 2004
Bachelor of Arts (B.A.), Journalism
Mindlance July 2015 - Present
Maetrics, LLC 2013 - August 2015
Roche Pharmaceuticals May 2006 - 2013
WJOB AM 1230 Hammond May 2005 - November 2005
Skills
Medical Devices, Quality Assurance, SAP, Call Centers, FDA, Microsoft Office, Pharmaceutical Industry, Process Improvement, Product Launch, Sop
Education
Indiana University Bloomington 2000 — 2004
Bachelor of Arts (B.A.), Journalism
Natasha Bhayani Natasha Bhayani's Maetrics, LLC Experience December 2012 - July 2013
Job Nursing Assistant II at Rush University Medical Center
Industry Pharmaceuticals
Experience
Rush University Medical Center October 2014 - Present
Fresenius Kabi USA August 2013 - January 2014
Maetrics, LLC December 2012 - July 2013
Baxter Healthcare July 2011 - October 2012
Skills
Microsoft Office, Data Analysis, Medical Devices, FDA, Western Blotting, Agarose Gel..., Bacterial Cell Culture, Microscopes, Autoclave, Aseptic Technique, Media Preparation, SPSS, Design Control, Quality Assurance, GxP, ISO 13485, ISO 14971, Clinical Research, Healthcare, PowerPoint
Education
DePaul University 2014 — 2015
Masters of Science in Nursing
University of Illinois at Chicago 2007 — 2011
Bachelor of Science (B.S.), Biology
Rush University Medical Center October 2014 - Present
Fresenius Kabi USA August 2013 - January 2014
Maetrics, LLC December 2012 - July 2013
Baxter Healthcare July 2011 - October 2012
Skills
Microsoft Office, Data Analysis, Medical Devices, FDA, Western Blotting, Agarose Gel..., Bacterial Cell Culture, Microscopes, Autoclave, Aseptic Technique, Media Preparation, SPSS, Design Control, Quality Assurance, GxP, ISO 13485, ISO 14971, Clinical Research, Healthcare, PowerPoint
Education
DePaul University 2014 — 2015
Masters of Science in Nursing
University of Illinois at Chicago 2007 — 2011
Bachelor of Science (B.S.), Biology
Jennifer Baughman's Maetrics, LLC Experience July 2005 - January 2009
Job Regional Quality Compliance Specialist at Siemens Molecular Imaging PETNET Solutions
Industry Biotechnology
Experience
Siemens Molecular Imaging - PETNET Solutions February 2012 - Present
Maetrics, LLC July 2005 - January 2009
Indiana Protein Technology December 2003 - July 2005
Wishard Hospital July 2003 - December 2003
Covance Bioanalytical Laboratories November 2000 - July 2003
Covance Central Laboratory Services February 1996 - November 2000
Skills
Attention To Detail, Microsoft Office, Critical Thinking, GLP, Sop, Validation, FDA, Biotechnology, Lifesciences, GMP, Pharmaceutical Industry, CAPA, Medical Devices, Immunology, Infectious Diseases, CTMS, Quality Assurance, Laboratory, Microbiology, Clinical Research, Quality Control, Clinical Trials
Education
LSU Medical Center 1993 — 1994
BS, Clinical Laboratory Science
Southeastern Louisiana University 1990 — 1993
Clinical Laboratory Science
Purdue University 1988 — 1990
Pharmacy
Siemens Molecular Imaging - PETNET Solutions February 2012 - Present
Maetrics, LLC July 2005 - January 2009
Indiana Protein Technology December 2003 - July 2005
Wishard Hospital July 2003 - December 2003
Covance Bioanalytical Laboratories November 2000 - July 2003
Covance Central Laboratory Services February 1996 - November 2000
Skills
Attention To Detail, Microsoft Office, Critical Thinking, GLP, Sop, Validation, FDA, Biotechnology, Lifesciences, GMP, Pharmaceutical Industry, CAPA, Medical Devices, Immunology, Infectious Diseases, CTMS, Quality Assurance, Laboratory, Microbiology, Clinical Research, Quality Control, Clinical Trials
Education
LSU Medical Center 1993 — 1994
BS, Clinical Laboratory Science
Southeastern Louisiana University 1990 — 1993
Clinical Laboratory Science
Purdue University 1988 — 1990
Pharmacy
Angela Stinson-Adams, Lean Six Sigma Certified Angela Stinson-Adams, Lean Six Sigma Certified's Maetrics, LLC Experience May 2013 - August 2013
Job Director of Quality at Celtaxsys
Industry Pharmaceuticals
Experience
Celtaxsys September 2013 - Present
Maetrics, LLC May 2013 - August 2013
MEDA August 2010 - March 2013
Shionogi Pharma (formerly Sciele Pharma) July 2006 - April 2010
Sciele Pharma 2007 - 2008
Sciele Pharma 2006 - 2007
DeKalb County Schools2004-2006 2004 - 2006
Novartis June 1988 - June 2003
Novartis Ophthalmics 1999 - 2001
Novartis Ophthalmics 1997 - 1999
Skills
GCP, Regulatory Submissions, FDA, Change Control, GMP, Regulatory Affairs, CAPA, Validation, Sop, GLP, Quality Assurance, Quality System, Pharmaceutical Industry, Clinical Trials, Biotechnology, Medical Devices, Lifesciences, GxP, Regulatory Requirements, Clinical Development, Pharmaceutics, Design Control, IND, Pharmacovigilance, Drug Development, Technology Transfer, HPLC, Quality Auditing, ISO 13485, Quality Control, V&V, R&D, 21 CFR Part 11, Quality Management, Software Documentation, Computer System..., Biopharmaceuticals, Cleaning Validation, Six Sigma, Cross-functional Team..., Aseptic Processing, FDA GMP, CRO, Trackwise, Formulation, Analytical Chemistry, Oncology, Manufacturing, CTMS, Microbiology
Education
Converse College
Bachelor's Degree, Chemistry, minor Math/Computer Science
University of Tennessee
Hands-On Tablet Technology
Celtaxsys September 2013 - Present
Maetrics, LLC May 2013 - August 2013
MEDA August 2010 - March 2013
Shionogi Pharma (formerly Sciele Pharma) July 2006 - April 2010
Sciele Pharma 2007 - 2008
Sciele Pharma 2006 - 2007
DeKalb County Schools2004-2006 2004 - 2006
Novartis June 1988 - June 2003
Novartis Ophthalmics 1999 - 2001
Novartis Ophthalmics 1997 - 1999
Skills
GCP, Regulatory Submissions, FDA, Change Control, GMP, Regulatory Affairs, CAPA, Validation, Sop, GLP, Quality Assurance, Quality System, Pharmaceutical Industry, Clinical Trials, Biotechnology, Medical Devices, Lifesciences, GxP, Regulatory Requirements, Clinical Development, Pharmaceutics, Design Control, IND, Pharmacovigilance, Drug Development, Technology Transfer, HPLC, Quality Auditing, ISO 13485, Quality Control, V&V, R&D, 21 CFR Part 11, Quality Management, Software Documentation, Computer System..., Biopharmaceuticals, Cleaning Validation, Six Sigma, Cross-functional Team..., Aseptic Processing, FDA GMP, CRO, Trackwise, Formulation, Analytical Chemistry, Oncology, Manufacturing, CTMS, Microbiology
Education
Converse College
Bachelor's Degree, Chemistry, minor Math/Computer Science
University of Tennessee
Hands-On Tablet Technology
Kirsten (Ysseldyke) Jessen Kirsten (Ysseldyke) Jessen's Maetrics, LLC Experience May 2013 - February 2014
Job HR Coordinator at STANLEY Security
Industry Human Resources
Experience
STANLEY Security June 2014 - Present
Maetrics, LLC May 2013 - February 2014
Boehringer Ingelheim April 2012 - January 2013
Eastman Kodak May 2010 - August 2010
Skills
Spanish, Microsoft Excel, Recruiting, Research, PowerPoint, Editing, Microsoft Word, Microsoft Office, Customer Service, Outlook, Teamwork, Human Resources, Photoshop, Sourcing, Telephone Interviewing, Screening, Taleo, Applicant Tracking..., Salesforce.com, Temporary Placement, Talent Acquisition, Internet Recruiting, College Recruiting, Technical Recruiting, Onboarding
Education
DePauw University 2009 — 2013
Bachelor of Arts, English, Spanish
STANLEY Security June 2014 - Present
Maetrics, LLC May 2013 - February 2014
Boehringer Ingelheim April 2012 - January 2013
Eastman Kodak May 2010 - August 2010
Skills
Spanish, Microsoft Excel, Recruiting, Research, PowerPoint, Editing, Microsoft Word, Microsoft Office, Customer Service, Outlook, Teamwork, Human Resources, Photoshop, Sourcing, Telephone Interviewing, Screening, Taleo, Applicant Tracking..., Salesforce.com, Temporary Placement, Talent Acquisition, Internet Recruiting, College Recruiting, Technical Recruiting, Onboarding
Education
DePauw University 2009 — 2013
Bachelor of Arts, English, Spanish
Peter Sobotta Peter Sobotta's Maetrics, LLC Experience January 2014 - June 2014
Job Sr. Compliance Consultant at Validant
Industry Medical Devices
Experience
Validant September 2014 - Present
R&Q June 2014 - September 2014
Maetrics, LLC January 2014 - June 2014
Hospira January 2012 - January 2014
Ethicon Endo-Surgery April 2010 - January 2012
Mercy Mt. Airy Hospital August 2009 - December 2011
Riverhills Healthcare, Inc. October 2008 - August 2009
Innovex April 2005 - November 2007
Skills
Clinical Research, Cardiology, Healthcare, Medical Devices, Oncology, Hospitals, Clinical Trials, Surgery, Neurology, Medicine, Managed Care, Critical Care, Diabetes, Patient Safety, FDA, Regulatory Affairs, Pharmaceutical Industry, ISO 13485, CAPA, SOP, GCP
Education
Concordia University-Wisconsin 2002 — 2005
BSN, Nursing
Validant September 2014 - Present
R&Q June 2014 - September 2014
Maetrics, LLC January 2014 - June 2014
Hospira January 2012 - January 2014
Ethicon Endo-Surgery April 2010 - January 2012
Mercy Mt. Airy Hospital August 2009 - December 2011
Riverhills Healthcare, Inc. October 2008 - August 2009
Innovex April 2005 - November 2007
Skills
Clinical Research, Cardiology, Healthcare, Medical Devices, Oncology, Hospitals, Clinical Trials, Surgery, Neurology, Medicine, Managed Care, Critical Care, Diabetes, Patient Safety, FDA, Regulatory Affairs, Pharmaceutical Industry, ISO 13485, CAPA, SOP, GCP
Education
Concordia University-Wisconsin 2002 — 2005
BSN, Nursing
Federico Perez's Maetrics, LLC Experience April 2013 - Present
Job Operations Manager at Maetrics
Industry Medical Devices
Experience
Maetrics, LLC April 2013 - Present
Zimmer December 2007 - April 2013
Maetrics LLC November 2006 - April 2013
Boston Scientific November 2006 - September 2007
Baxter Healthcare May 2005 - November 2006
Baxter Healthcare June 2002 - May 2005
Skills
V&V, Quality System, Minitab, Validation, CAPA, ISO 13485, Medical Devices, FDA, FMEA, Quality Auditing, Design of Experiments, 21 CFR Part 11, GMP, Six Sigma, Change Control, Design Control, Root Cause Analysis, Process Simulation, Computer System..., Pharmaceutical Industry, Manufacturing, ISO, Process Engineering, Lean Manufacturing, ISO 14971, Process Improvement, SPC, DMAIC, Organizational..., Quality Assurance, Quality Control
Education
Instituto Tecnológico de Santo Domingo 2005 — 2006
Post Bachelor's in Quality and Productivity Management, Engineering
Instituto Tecnológico de Santo Domingo 1999 — 2003
Industrial Engineer, Engineering
Maetrics, LLC April 2013 - Present
Zimmer December 2007 - April 2013
Maetrics LLC November 2006 - April 2013
Boston Scientific November 2006 - September 2007
Baxter Healthcare May 2005 - November 2006
Baxter Healthcare June 2002 - May 2005
Skills
V&V, Quality System, Minitab, Validation, CAPA, ISO 13485, Medical Devices, FDA, FMEA, Quality Auditing, Design of Experiments, 21 CFR Part 11, GMP, Six Sigma, Change Control, Design Control, Root Cause Analysis, Process Simulation, Computer System..., Pharmaceutical Industry, Manufacturing, ISO, Process Engineering, Lean Manufacturing, ISO 14971, Process Improvement, SPC, DMAIC, Organizational..., Quality Assurance, Quality Control
Education
Instituto Tecnológico de Santo Domingo 2005 — 2006
Post Bachelor's in Quality and Productivity Management, Engineering
Instituto Tecnológico de Santo Domingo 1999 — 2003
Industrial Engineer, Engineering
Tracy Gutierrez's Maetrics, LLC Experience September 2013 - December 2014
Job Regulatory Affairs Specialist
Industry Medical Devices
Experience
DePuy Synthes December 2014 - Present
Maetrics, LLC September 2013 - December 2014
Roche Diagnostics October 2007 - September 2013
Roche Diagnostics November 2006 - October 2007
Roche Diagnostics June 2004 - November 2006
Skills
Coaching, Feedback, SAP, MS Office, Customer Service, Medical Devices, FDA
Education
Butler University 1999 — 2003
Bachelor of Arts (B.A.), Psychology
DePuy Synthes December 2014 - Present
Maetrics, LLC September 2013 - December 2014
Roche Diagnostics October 2007 - September 2013
Roche Diagnostics November 2006 - October 2007
Roche Diagnostics June 2004 - November 2006
Skills
Coaching, Feedback, SAP, MS Office, Customer Service, Medical Devices, FDA
Education
Butler University 1999 — 2003
Bachelor of Arts (B.A.), Psychology
Daniel New's Maetrics, LLC Experience February 2013 - July 2014
Job Contract Recruiter at Theoris
Industry Biotechnology
Experience
Theoris July 2014 - Present
Maetrics, LLC February 2013 - July 2014
Kelly Services June 2012 - January 2013
AIT Laboratories January 2012 - June 2012
AIT Laboratories January 2011 - December 2011
Advanced Testing Laboratory February 2010 - June 2010
IUPUI May 2009 - June 2009
Henry County Hospital September 2005 - March 2009
New's Bushi-Kai Martial Arts October 2004 - March 2007
Skills
Phlebotomy, Cell Culture, Personal Training, Karate, Martial Arts, leadership, Team Leadership, Leading Change, Customer Relations, Customer Service, Analysis, Organizational..., Recruiting, Technical Recruiting, Strategy, Coaching, Leadership, CRM, Management, Validation, Training, Research, Sales
Education
Indiana University-Purdue University at Indianapolis 2007 — 2009
Bachelors, General Studies-Math and Science Focus
Ball State University 2004 — 2006
Associates, General Arts
Tri Jr. Sr. High School
Theoris July 2014 - Present
Maetrics, LLC February 2013 - July 2014
Kelly Services June 2012 - January 2013
AIT Laboratories January 2012 - June 2012
AIT Laboratories January 2011 - December 2011
Advanced Testing Laboratory February 2010 - June 2010
IUPUI May 2009 - June 2009
Henry County Hospital September 2005 - March 2009
New's Bushi-Kai Martial Arts October 2004 - March 2007
Skills
Phlebotomy, Cell Culture, Personal Training, Karate, Martial Arts, leadership, Team Leadership, Leading Change, Customer Relations, Customer Service, Analysis, Organizational..., Recruiting, Technical Recruiting, Strategy, Coaching, Leadership, CRM, Management, Validation, Training, Research, Sales
Education
Indiana University-Purdue University at Indianapolis 2007 — 2009
Bachelors, General Studies-Math and Science Focus
Ball State University 2004 — 2006
Associates, General Arts
Tri Jr. Sr. High School
Dylan Nix's Maetrics, LLC Experience August 2011 - October 2013
Job Writer / Game Designer / Guitar Technician
Industry Writing and Editing
Experience
Self-Employed October 2013 - May 2014
Maetrics, LLC August 2011 - October 2013
Will-Drill Resources, Inc. February 2011 - July 2011
LSUS Campus Wide Lab August 2009 - December 2010
LSUS Computer Science Department January 2009 - July 2009
Skills
Microsoft Office, HTML, Software Documentation, Editing, Microsoft Excel, Troubleshooting, Technical Writing, Integration, Quality Assurance, Training
Education
Galloup School of Guitar Building and Repair 2014 — 2014
Certified Fretted Instrument Repair Technician
LSU Shreveport 2008 — 2010
BGS, Humanities, Computer Science
Louisiana State University 2005 — 2007
English, Theatre
Self-Employed October 2013 - May 2014
Maetrics, LLC August 2011 - October 2013
Will-Drill Resources, Inc. February 2011 - July 2011
LSUS Campus Wide Lab August 2009 - December 2010
LSUS Computer Science Department January 2009 - July 2009
Skills
Microsoft Office, HTML, Software Documentation, Editing, Microsoft Excel, Troubleshooting, Technical Writing, Integration, Quality Assurance, Training
Education
Galloup School of Guitar Building and Repair 2014 — 2014
Certified Fretted Instrument Repair Technician
LSU Shreveport 2008 — 2010
BGS, Humanities, Computer Science
Louisiana State University 2005 — 2007
English, Theatre
Cathy Behrendt's Maetrics, LLC Experience September 2013 - April 2014
Job Regulatory Affairs Manager
Industry Medical Devices
Experience
Carestream January 2015 - Present
Oxford International July 2014 - December 2014
Maetrics, LLC September 2013 - April 2014
LSI Solutions August 2012 - September 2013
Robert Bosch Healthcare Systems, Inc. April 2011 - June 2012
Conmed Corporation November 2006 - March 2011
RadioShack October 2004 - August 2005
RadioShack January 1998 - October 2004
Skills
Regulatory Affairs, Quality Assurance, Technical Writing, Certified Project..., Technical File..., Design Control, IEC 62304, EN 980, EN 1041, ISO 15223-2, IEC 60601-1 3rd Edition, ANSI/AAMI TIR 80002-1, Cytotoxicity, Bioburden, Sterilization, Risk Management, Medical Devices, European Union, Design Documents, Design History, Post Market Surveillance, Biocompatibility, Medical Terminology, FDA, V&V, Regulatory Submissions, CE marking, 21 CFR Part 11, Software Documentation, Electronics, Product Development, Validation, ISO 14971, GMP, ISO 13485, Process Improvement, PMA, Medical Device Directive, 21 CFR, Change Control, Warning Letter..., Regulatory Requirements, Quality System, ISO, Quality Auditing, Project Management
Education
Northeastern University 2009 — 2011
Master of Science, Regulatory Affairs Drugs, Biologics and Medical Devices, 3.57
Northeastern University 2009 — 2010
Graduate Certificate, Medical Device Regulatory Affairs
SUNY Polytechnic Institute 1992 — 1994
BS, Healthcare Management
Carestream January 2015 - Present
Oxford International July 2014 - December 2014
Maetrics, LLC September 2013 - April 2014
LSI Solutions August 2012 - September 2013
Robert Bosch Healthcare Systems, Inc. April 2011 - June 2012
Conmed Corporation November 2006 - March 2011
RadioShack October 2004 - August 2005
RadioShack January 1998 - October 2004
Skills
Regulatory Affairs, Quality Assurance, Technical Writing, Certified Project..., Technical File..., Design Control, IEC 62304, EN 980, EN 1041, ISO 15223-2, IEC 60601-1 3rd Edition, ANSI/AAMI TIR 80002-1, Cytotoxicity, Bioburden, Sterilization, Risk Management, Medical Devices, European Union, Design Documents, Design History, Post Market Surveillance, Biocompatibility, Medical Terminology, FDA, V&V, Regulatory Submissions, CE marking, 21 CFR Part 11, Software Documentation, Electronics, Product Development, Validation, ISO 14971, GMP, ISO 13485, Process Improvement, PMA, Medical Device Directive, 21 CFR, Change Control, Warning Letter..., Regulatory Requirements, Quality System, ISO, Quality Auditing, Project Management
Education
Northeastern University 2009 — 2011
Master of Science, Regulatory Affairs Drugs, Biologics and Medical Devices, 3.57
Northeastern University 2009 — 2010
Graduate Certificate, Medical Device Regulatory Affairs
SUNY Polytechnic Institute 1992 — 1994
BS, Healthcare Management
Dana Colston Jr. Dana Colston Jr.'s Maetrics, LLC Experience 2009 - Present
Job
Industry Medical Devices
Experience
Maetrics, LLC 2009 - Present
Baxter Healthcare September 2007 - May 2009
Boston Scientific December 2006 - August 2007
Kraft Foods Group June 2005 - August 2005
Kraft Foods Group June 2004 - August 2004
Skills
V&V, FDA, Validation, Six Sigma, FMEA, Minitab, Medical Devices, DMAIC, R&D, Change Control, Quality Control, Quality System, ISO 13485, Process Engineering, Process Simulation, Testing, Cross-functional Team...
Education
Michigan State University 2002 — 2006
BS, Chemical Engineering
Volgograd State University of Architecture and Civil Engineering 2006 — 2006
Volgograd, Russia
Maetrics, LLC 2009 - Present
Baxter Healthcare September 2007 - May 2009
Boston Scientific December 2006 - August 2007
Kraft Foods Group June 2005 - August 2005
Kraft Foods Group June 2004 - August 2004
Skills
V&V, FDA, Validation, Six Sigma, FMEA, Minitab, Medical Devices, DMAIC, R&D, Change Control, Quality Control, Quality System, ISO 13485, Process Engineering, Process Simulation, Testing, Cross-functional Team...
Education
Michigan State University 2002 — 2006
BS, Chemical Engineering
Volgograd State University of Architecture and Civil Engineering 2006 — 2006
Volgograd, Russia
Garth Smitman Garth Smitman's Maetrics, LLC Experience December 2013 - December 2014
Job Calm and Relentless Expert
Industry Medical Devices
Experience
Meggitt Piezo Technologies August 2014 - Present
MAETRICS April 2014 - January 2015
Maetrics, LLC December 2013 - December 2014
King Systems December 2013 - June 2014
G&H Wire August 2011 - December 2013
Performance Validation November 2008 - August 2011
American Society for Quality 2005 - August 2011
Performance Validation June 2001 - August 2011
Performance Validation June 2001 - August 2011
Toastmasters International April 2008 - June 2010
Skills
Quality System, Continuous Improvement, Quality Management, Quality Assurance, Quality Control, Validation, GMP, PMP, Six Sigma, Quality Auditing, CQA, ISO 13485, Root Cause Analysis, CAPA, Process Engineering, Microsoft Office, V&V, Process Improvement, DMAIC, Change Control, Manufacturing, Software Documentation, Medical Devices, Training, FDA, SPC, Leadership, Management, Supplier Quality, Employee Training, Computer System..., Program Management, Project Planning, 21 CFR Part 11, Cross-functional Team..., Public Speaking, ISO, Lean Manufacturing, Operational Excellence, TQM, Pharmaceutical Industry
Education
Purdue University 1998 — 2001
BS, Chemical Engineering
Montana State University-Billings 1996 — 1998
hours towards BS, Chemistry
Harlem High School 1984 — 1988
HS Diploma, College Prep
Meggitt Piezo Technologies August 2014 - Present
MAETRICS April 2014 - January 2015
Maetrics, LLC December 2013 - December 2014
King Systems December 2013 - June 2014
G&H Wire August 2011 - December 2013
Performance Validation November 2008 - August 2011
American Society for Quality 2005 - August 2011
Performance Validation June 2001 - August 2011
Performance Validation June 2001 - August 2011
Toastmasters International April 2008 - June 2010
Skills
Quality System, Continuous Improvement, Quality Management, Quality Assurance, Quality Control, Validation, GMP, PMP, Six Sigma, Quality Auditing, CQA, ISO 13485, Root Cause Analysis, CAPA, Process Engineering, Microsoft Office, V&V, Process Improvement, DMAIC, Change Control, Manufacturing, Software Documentation, Medical Devices, Training, FDA, SPC, Leadership, Management, Supplier Quality, Employee Training, Computer System..., Program Management, Project Planning, 21 CFR Part 11, Cross-functional Team..., Public Speaking, ISO, Lean Manufacturing, Operational Excellence, TQM, Pharmaceutical Industry
Education
Purdue University 1998 — 2001
BS, Chemical Engineering
Montana State University-Billings 1996 — 1998
hours towards BS, Chemistry
Harlem High School 1984 — 1988
HS Diploma, College Prep
Yevgeny Baburin's Maetrics, LLC Experience January 2011 - Present
Job Quality Consultant at Maetrics, LLC
Industry Nonprofit Organization Management
Experience
Maetrics, LLC January 2011 - Present
NUVO March 2009 - Present
NUVO June 2010 - June 2011
Freelance June 2010 - June 2011
Noblesville Music Center September 2006 - August 2010
NUVO July 2009 - December 2009
Indianapolis Peace and Justice Center May 2009 - August 2009
Indianapolis Peace and Justice February 2009 - May 2009
Indianapolis Peace and Justice Center July 2008 - January 2009
Skills
Technical Writing, 21 CFR 820, 21 CFR 803, Microsoft Office, cGMP, GMP, 21 CFR, Validation, Editing, Software Documentation
Education
Indiana University
Bachelor of arts, journalism
Indiana University-Purdue University at Indianapolis
Maetrics, LLC January 2011 - Present
NUVO March 2009 - Present
NUVO June 2010 - June 2011
Freelance June 2010 - June 2011
Noblesville Music Center September 2006 - August 2010
NUVO July 2009 - December 2009
Indianapolis Peace and Justice Center May 2009 - August 2009
Indianapolis Peace and Justice February 2009 - May 2009
Indianapolis Peace and Justice Center July 2008 - January 2009
Skills
Technical Writing, 21 CFR 820, 21 CFR 803, Microsoft Office, cGMP, GMP, 21 CFR, Validation, Editing, Software Documentation
Education
Indiana University
Bachelor of arts, journalism
Indiana University-Purdue University at Indianapolis
Joe Byars, PMP Joe Byars, PMP's Maetrics, LLC Experience April 2014 - April 2015
Job Director, R&D at Stroma Medical Corporation
Industry Medical Devices
Experience
Stroma Medical Corporation May 2015 - Present
Maetrics LLC April 2014 - April 2015
Sysmex America, Inc. August 2011 - March 2014
Abbott Medical Optics August 2004 - October 2010
Masimo Corporation May 1997 - July 2004
Baxter Paramax February 1986 - February 1997
Skills
Field Service, Medical Devices, ISO 13485, Design Control, Medical Imaging, Management, Project Management, Calibration, PMP, Six Sigma, Validation, Cross-functional Team..., Quality System, CAPA, Quality Assurance, Process Improvement, R&D, Hardware Diagnostics, Quality Management, Testing, Kaizen, Electronics, FDA, Lifesciences, V&V, Biomedical Engineering, Product Development, Sop, Change Control, Commercialization, GMP, Biotechnology, Manufacturing, 21 CFR Part 11, Pharmaceutical Industry, Budgets, Product Launch
Education
National University 1983 — 1984
Computer Science
Stroma Medical Corporation May 2015 - Present
Maetrics LLC April 2014 - April 2015
Sysmex America, Inc. August 2011 - March 2014
Abbott Medical Optics August 2004 - October 2010
Masimo Corporation May 1997 - July 2004
Baxter Paramax February 1986 - February 1997
Skills
Field Service, Medical Devices, ISO 13485, Design Control, Medical Imaging, Management, Project Management, Calibration, PMP, Six Sigma, Validation, Cross-functional Team..., Quality System, CAPA, Quality Assurance, Process Improvement, R&D, Hardware Diagnostics, Quality Management, Testing, Kaizen, Electronics, FDA, Lifesciences, V&V, Biomedical Engineering, Product Development, Sop, Change Control, Commercialization, GMP, Biotechnology, Manufacturing, 21 CFR Part 11, Pharmaceutical Industry, Budgets, Product Launch
Education
National University 1983 — 1984
Computer Science
Dean Murphy, RAC Dean Murphy, RAC's Maetrics, LLC Experience February 2013 - Present
Job Accomplished Regulatory Affairs, Compliance and Quality Professional in Pharma/MedDev/Biotech Industry
Industry Pharmaceuticals
Experience
Consultant, Self Employed June 2015 - Present
Maetrics, LLC February 2013 - Present
Vistakon, division of Johnson and Johnson Vision Care, Inc. October 2009 - December 2012
Ligand Pharmaceuticals January 2009 - December 2009
Pharmacopeia, Inc. July 2007 - December 2008
Chugai Pharma USA, Ltd. March 2006 - July 2007
Alteon Inc. October 2004 - February 2006
Novartis September 2003 - October 2004
Novartis 1998 - 2003
Bausch & Lomb 1995 - 1996
Skills
Quality Control, Pharmaceutical Industry, FDA, Biotechnology, GCP, Regulatory Submissions, Clinical Trials, Regulatory Affairs, Medical Devices, Clinical Development, Sop, Clinical Research, GMP, Validation, eCTD, GLP, IND, NDA, Drug Development, Quality System, GxP, Regulatory Requirements, Design Control, CMC, Regulatory Filings, Combination Products, Change Control, Electronic Submissions, Quality Assurance, Regulatory Documentation, ICH-GCP, Aseptic Processing, R&D, CRO, Commercialization, Pharmaceutics, CAPA, Biopharmaceuticals, V&V, 21 CFR Part 11, ISO 14971, ISO 13485, Computer System..., Laboratory, Technology Transfer, Chemistry, LIMS, PMA, Quality Management, Life Sciences
Education
Stockton University 1978 — 1980
BS, Biology
Burlington County College 1976 — 1978
Bachelor's degree, Biology/Biological Sciences, General
Consultant, Self Employed June 2015 - Present
Maetrics, LLC February 2013 - Present
Vistakon, division of Johnson and Johnson Vision Care, Inc. October 2009 - December 2012
Ligand Pharmaceuticals January 2009 - December 2009
Pharmacopeia, Inc. July 2007 - December 2008
Chugai Pharma USA, Ltd. March 2006 - July 2007
Alteon Inc. October 2004 - February 2006
Novartis September 2003 - October 2004
Novartis 1998 - 2003
Bausch & Lomb 1995 - 1996
Skills
Quality Control, Pharmaceutical Industry, FDA, Biotechnology, GCP, Regulatory Submissions, Clinical Trials, Regulatory Affairs, Medical Devices, Clinical Development, Sop, Clinical Research, GMP, Validation, eCTD, GLP, IND, NDA, Drug Development, Quality System, GxP, Regulatory Requirements, Design Control, CMC, Regulatory Filings, Combination Products, Change Control, Electronic Submissions, Quality Assurance, Regulatory Documentation, ICH-GCP, Aseptic Processing, R&D, CRO, Commercialization, Pharmaceutics, CAPA, Biopharmaceuticals, V&V, 21 CFR Part 11, ISO 14971, ISO 13485, Computer System..., Laboratory, Technology Transfer, Chemistry, LIMS, PMA, Quality Management, Life Sciences
Education
Stockton University 1978 — 1980
BS, Biology
Burlington County College 1976 — 1978
Bachelor's degree, Biology/Biological Sciences, General
Sheryl Roark Sheryl Roark's Maetrics, LLC Experience February 2008 - August 2008
Job Sr. Consulting Engineer
Industry Medical Devices
Experience
Currently seeking a new validation / compliance project within FDA regulated industries. July 2015 - Present
Business Owner - doTERRA November 2014 - Present
Enhanced Compliance, Inc. at Atrium Medical December 2013 - July 2015
Roche Diagnostics August 2008 - November 2013
Maetrics, LLC February 2008 - August 2008
Boston Scientific March 2006 - February 2008
General Motors Powertrain October 2005 - January 2006
TRW Automotive February 2005 - September 2005
Pfizer, Inc. August 2004 - December 2004
Applied Extrusion Technologies June 2004 - August 2004
Skills
Medical Devices, FDA, Troubleshooting, Validation, Value Stream Mapping, Continuous Improvement, ISO 13485, V&V, FMEA, Quality System, Root Cause Analysis, Product Development, CAPA, 21 CFR Part 11, 5S, Calibration, Design Control, Design for Manufacturing, Design of Experiments, Engineering, GMP, ISO, Kaizen, Lean Manufacturing, Manufacturing..., Manufacturing Operations, Process Capability, Process Engineering, Process Improvement, Quality Control, SPC, Six Sigma, Sop, DMAIC, SOP
Education
Indiana State University 2002 — 2004
M.S., Human Resource Development
Indiana State University 1991 — 1995
B.S., Industrial Mechanical Technology
Indiana State University 1991 — 1995
B.S., Electronics Technology
Vincennes University 1989 — 1991
A.S., Laser Electro-Optics Technology
North Daviess High School 1976 — 1980
Currently seeking a new validation / compliance project within FDA regulated industries. July 2015 - Present
Business Owner - doTERRA November 2014 - Present
Enhanced Compliance, Inc. at Atrium Medical December 2013 - July 2015
Roche Diagnostics August 2008 - November 2013
Maetrics, LLC February 2008 - August 2008
Boston Scientific March 2006 - February 2008
General Motors Powertrain October 2005 - January 2006
TRW Automotive February 2005 - September 2005
Pfizer, Inc. August 2004 - December 2004
Applied Extrusion Technologies June 2004 - August 2004
Skills
Medical Devices, FDA, Troubleshooting, Validation, Value Stream Mapping, Continuous Improvement, ISO 13485, V&V, FMEA, Quality System, Root Cause Analysis, Product Development, CAPA, 21 CFR Part 11, 5S, Calibration, Design Control, Design for Manufacturing, Design of Experiments, Engineering, GMP, ISO, Kaizen, Lean Manufacturing, Manufacturing..., Manufacturing Operations, Process Capability, Process Engineering, Process Improvement, Quality Control, SPC, Six Sigma, Sop, DMAIC, SOP
Education
Indiana State University 2002 — 2004
M.S., Human Resource Development
Indiana State University 1991 — 1995
B.S., Industrial Mechanical Technology
Indiana State University 1991 — 1995
B.S., Electronics Technology
Vincennes University 1989 — 1991
A.S., Laser Electro-Optics Technology
North Daviess High School 1976 — 1980
Charles McIver's Maetrics, LLC Experience February 2013 - January 2015
Job Compliance and Quality Consultant at Maetrics, LLC
Industry Mechanical or Industrial Engineering
Experience
Maetrics, LLC February 2013 - January 2015
Kelly Services July 2012 - January 2013
TIAA-CREF September 2010 - December 2010
Career search February 2009 - September 2010
Signature Aluminum May 2007 - January 2009
Atlantis Technical Services October 2006 - May 2007
Atlantis Technical Services August 2005 - September 2006
Cardiocom, Inc February 2005 - June 2005
Minneapolis Public Schools December 2003 - January 2005
DBI/SALA June 2004 - November 2004
Skills
Process Improvement, Lean Manufacturing, Six Sigma, Internal Audit, Manufacturing, CAPA, Continuous Improvement, Engineering, DMAIC, ISO, Industrial Engineering, Quality Auditing, Quality Control, Quality Management, Quality System, Root Cause Analysis, SPC, Sop, Technical Writing, Training, Business Process, SOP
Education
North Carolina State University 1977 — 1984
BS, Industrial Engineering
North Carolina State University 1977 — 1984
Bachelor of Science (BS), Industrial Engineering
Maetrics, LLC February 2013 - January 2015
Kelly Services July 2012 - January 2013
TIAA-CREF September 2010 - December 2010
Career search February 2009 - September 2010
Signature Aluminum May 2007 - January 2009
Atlantis Technical Services October 2006 - May 2007
Atlantis Technical Services August 2005 - September 2006
Cardiocom, Inc February 2005 - June 2005
Minneapolis Public Schools December 2003 - January 2005
DBI/SALA June 2004 - November 2004
Skills
Process Improvement, Lean Manufacturing, Six Sigma, Internal Audit, Manufacturing, CAPA, Continuous Improvement, Engineering, DMAIC, ISO, Industrial Engineering, Quality Auditing, Quality Control, Quality Management, Quality System, Root Cause Analysis, SPC, Sop, Technical Writing, Training, Business Process, SOP
Education
North Carolina State University 1977 — 1984
BS, Industrial Engineering
North Carolina State University 1977 — 1984
Bachelor of Science (BS), Industrial Engineering
Larry McElhiney Larry McElhiney's Maetrics, LLC Experience September 2004 - Present
Job Quality Consultant at Maetrics, LLC
Industry Medical Devices
Experience
Maetrics, LLC September 2004 - Present
Maetrics, LLC 2004 - Present
Eli Lilly October 2001 - September 2004
DPS Telecom 1999 - 2000
Plantronics 1977 - 1998
Avantek, Inc. 1974 - 1977
United States Air Force 1966 - 1970
Skills
Quality Assurance, Validation, FDA, Quality System, Medical Devices, Quality Auditing, ISO 13485, ISO, Quality Control, Computer System..., Management, Manufacturing, 21 CFR Part 11, Training, ISO 14971, Lean Manufacturing, SPC, FMEA, Iso 9000, Process Improvement, CAPA, GMP, Quality Management, Cross-functional Team..., Change Control, Telecommunications, Design Control, GxP, DMAIC, Sop, Technical Writing, Testing, Root Cause Analysis, Process Simulation, Pharmaceutical Industry, Biotechnology, Process Engineering, Technology Transfer, GAMP, Auditing, Software Documentation, Continuous Improvement, R&D, Document Management, Linux, Regulatory Affairs, Complaint Investigations, Gap Analysis, Macintosh Hardware, Mac OS
Education
Weber State University 1970 — 1974
De Anza College
Maetrics, LLC September 2004 - Present
Maetrics, LLC 2004 - Present
Eli Lilly October 2001 - September 2004
DPS Telecom 1999 - 2000
Plantronics 1977 - 1998
Avantek, Inc. 1974 - 1977
United States Air Force 1966 - 1970
Skills
Quality Assurance, Validation, FDA, Quality System, Medical Devices, Quality Auditing, ISO 13485, ISO, Quality Control, Computer System..., Management, Manufacturing, 21 CFR Part 11, Training, ISO 14971, Lean Manufacturing, SPC, FMEA, Iso 9000, Process Improvement, CAPA, GMP, Quality Management, Cross-functional Team..., Change Control, Telecommunications, Design Control, GxP, DMAIC, Sop, Technical Writing, Testing, Root Cause Analysis, Process Simulation, Pharmaceutical Industry, Biotechnology, Process Engineering, Technology Transfer, GAMP, Auditing, Software Documentation, Continuous Improvement, R&D, Document Management, Linux, Regulatory Affairs, Complaint Investigations, Gap Analysis, Macintosh Hardware, Mac OS
Education
Weber State University 1970 — 1974
De Anza College
Colleen Buchanan Colleen Buchanan's Maetrics, LLC Experience November 2013 - March 2014
Job Senior Regulatory Affairs Specialist at American Medical Systems
Industry Biotechnology
Experience
American Medical Systems April 2014 - Present
Maetrics, LLC November 2013 - March 2014
Smiths Medical April 2012 - April 2013
AGA Medical July 2011 - December 2011
Beckman Coulter July 2008 - July 2011
Lifecore Biomedical January 2008 - April 2008
University of Minnesota August 2002 - January 2008
Skills
Medical Devices, Regulatory Requirements, FDA, Regulatory Affairs, Quality System, CAPA, Design Control, ISO 13485, Quality Auditing
Education
College of Saint Benedict 1993 — 1997
American Medical Systems April 2014 - Present
Maetrics, LLC November 2013 - March 2014
Smiths Medical April 2012 - April 2013
AGA Medical July 2011 - December 2011
Beckman Coulter July 2008 - July 2011
Lifecore Biomedical January 2008 - April 2008
University of Minnesota August 2002 - January 2008
Skills
Medical Devices, Regulatory Requirements, FDA, Regulatory Affairs, Quality System, CAPA, Design Control, ISO 13485, Quality Auditing
Education
College of Saint Benedict 1993 — 1997
Nadia C. Zelaya Nadia C. Zelaya's Maetrics, LLC Experience December 2012 - January 2013
Job Independent Consultant, QC Microbiology in Pharma, Biotechnology & Medical Devices
Industry Pharmaceuticals
Experience
Corning Life Sciences April 2013 - May 2015
PAREXEL January 2013 - March 2013
Maetrics, LLC December 2012 - January 2013
ProPharma Group May 2012 - December 2012
BD July 2009 - April 2012
Schering-Plough October 2007 - July 2009
Biotest Pharmaceuticals Corporation (formerly Nabi Biopharmaceuticals) July 2006 - October 2007
American Express September 2000 - July 2007
Skills
Microbiology, Validation, FDA, Sop, CAPA, GMP, Quality Assurance, Quality Auditing, Root Cause Analysis, Quality System, Regulatory Affairs, ISO, Pharmaceutical Industry, Change Control, Quality Management, Manufacturing, GLP, ISO 13485, Aseptic Processing, Computer System..., Cleaning Validation, Technology Transfer, Trackwise, Quality Control, Biotechnology, 21 CFR Part 11, Biopharmaceuticals, Deviations, Environmental Monitoring, GxP, Iso 9000, LIMS, Laboratory, Sterilization, USP, Regulatory Requirements, Lifesciences, FDA GMP, Aseptic Technique, 21 CFR, Cell Culture, Equipment Qualification, Pharmaceutics, SOP, Life Sciences
Education
Florida Atlantic University 2002 — 2005
BS, Microbiology, Molecular Genetics, Biotechnology
Le Cordon Bleu College of Culinary Arts-Miami 2008 — 2009
Diploma in Patisserie and Baking, Patisserie and Baking
Corning Life Sciences April 2013 - May 2015
PAREXEL January 2013 - March 2013
Maetrics, LLC December 2012 - January 2013
ProPharma Group May 2012 - December 2012
BD July 2009 - April 2012
Schering-Plough October 2007 - July 2009
Biotest Pharmaceuticals Corporation (formerly Nabi Biopharmaceuticals) July 2006 - October 2007
American Express September 2000 - July 2007
Skills
Microbiology, Validation, FDA, Sop, CAPA, GMP, Quality Assurance, Quality Auditing, Root Cause Analysis, Quality System, Regulatory Affairs, ISO, Pharmaceutical Industry, Change Control, Quality Management, Manufacturing, GLP, ISO 13485, Aseptic Processing, Computer System..., Cleaning Validation, Technology Transfer, Trackwise, Quality Control, Biotechnology, 21 CFR Part 11, Biopharmaceuticals, Deviations, Environmental Monitoring, GxP, Iso 9000, LIMS, Laboratory, Sterilization, USP, Regulatory Requirements, Lifesciences, FDA GMP, Aseptic Technique, 21 CFR, Cell Culture, Equipment Qualification, Pharmaceutics, SOP, Life Sciences
Education
Florida Atlantic University 2002 — 2005
BS, Microbiology, Molecular Genetics, Biotechnology
Le Cordon Bleu College of Culinary Arts-Miami 2008 — 2009
Diploma in Patisserie and Baking, Patisserie and Baking
Leanne Cobb Leanne Cobb's Maetrics, LLC Experience April 2013 - March 2014
Job Environmental Health & Safety Coordinator Chemical and Radiation Safety & Environmental Programs
Industry Environmental Services
Experience
Florida Atlantic University January 2015 - Present
URS Corporation September 2014 - February 2015
Maetrics, LLC April 2013 - March 2014
Triumph Aerostructures - Vought Aircraft Division August 2008 - November 2012
Teknor Apex Company April 2001 - July 2008
Chemet Corp./Metalor Technologies 1999 - 2001
Radiation & Environmental Safety Training 1994 - 1999
Boston College 1992 - 1994
Environmental Testing Laboratories 1984 - January 1992
Cambridge Analytical Assoc. 1980 - 1983
Skills
Industrial Hygiene, Environmental Compliance, OSHA Record Keeping, Industrial Safety, RCRA, OSHA Safety, Environmental Health..., Radiation Safety, EHS, Ergonomics, Hazardous Waste..., Hazardous Materials, EPA, Safety Engineering, Hazard Analysis, Occupational Health, Training, Environmental Awareness, Environmental Health, Safety Management...
Education
Simmons College - Simmons School of Management 1983 — 1984
Master of Business Administration (MBA), Business Administration and Management, General
Boston College 1975 — 1979
Bachelor of Arts (B.A.), Physiological Psychology/Psychobiology, cum laude
Florida Atlantic University January 2015 - Present
URS Corporation September 2014 - February 2015
Maetrics, LLC April 2013 - March 2014
Triumph Aerostructures - Vought Aircraft Division August 2008 - November 2012
Teknor Apex Company April 2001 - July 2008
Chemet Corp./Metalor Technologies 1999 - 2001
Radiation & Environmental Safety Training 1994 - 1999
Boston College 1992 - 1994
Environmental Testing Laboratories 1984 - January 1992
Cambridge Analytical Assoc. 1980 - 1983
Skills
Industrial Hygiene, Environmental Compliance, OSHA Record Keeping, Industrial Safety, RCRA, OSHA Safety, Environmental Health..., Radiation Safety, EHS, Ergonomics, Hazardous Waste..., Hazardous Materials, EPA, Safety Engineering, Hazard Analysis, Occupational Health, Training, Environmental Awareness, Environmental Health, Safety Management...
Education
Simmons College - Simmons School of Management 1983 — 1984
Master of Business Administration (MBA), Business Administration and Management, General
Boston College 1975 — 1979
Bachelor of Arts (B.A.), Physiological Psychology/Psychobiology, cum laude
LaChon Allen-Covington LaChon Allen-Covington's Maetrics, LLC Experience February 2013 - Present
Job Complaint Investigator at MAETRICS
Industry Medical Devices
Experience
MAETRICS November 2014 - Present
Maetrics, LLC February 2013 - Present
Prodigy Diabetes Care June 2011 - January 2013
Talecris Plasma Resources January 2008 - May 2011
Northern California Transplant Bank May 2006 - December 2007
American Red Cross January 2004 - April 2006
Alpha Therapeutics Inc. May 2001 - December 2003
Skills
FDA, SOP, cGMP, GMP, Auditing, GLP, CAPA, Regulatory Affairs, Quality Systems, Quality Auditing, Validation, Change Control, Process Improvement, Quality Assurance, Compliance, Medical Devices, Quality Management, Documentation, Document Management, Technical Writing, Problem Solving, Mentoring, Quality System, Computer System..., Design Control, ISO, Training, 21 CFR Part 11, FDA GMP, V&V, GxP, Sop, GCP, Software Documentation, Regulatory Submissions, Quality Control, Six Sigma, Regulatory Requirements, Iso 9000, ISO 13485, ISO 14971, Calibration, CE marking, CQA, Technology Transfer, Testing, LIMS, Root Cause Analysis, Pharmaceutical Industry, Biotechnology
Education
California State University-Sacramento 1997 — 2000
BS, Health Sciences, Business
MAETRICS November 2014 - Present
Maetrics, LLC February 2013 - Present
Prodigy Diabetes Care June 2011 - January 2013
Talecris Plasma Resources January 2008 - May 2011
Northern California Transplant Bank May 2006 - December 2007
American Red Cross January 2004 - April 2006
Alpha Therapeutics Inc. May 2001 - December 2003
Skills
FDA, SOP, cGMP, GMP, Auditing, GLP, CAPA, Regulatory Affairs, Quality Systems, Quality Auditing, Validation, Change Control, Process Improvement, Quality Assurance, Compliance, Medical Devices, Quality Management, Documentation, Document Management, Technical Writing, Problem Solving, Mentoring, Quality System, Computer System..., Design Control, ISO, Training, 21 CFR Part 11, FDA GMP, V&V, GxP, Sop, GCP, Software Documentation, Regulatory Submissions, Quality Control, Six Sigma, Regulatory Requirements, Iso 9000, ISO 13485, ISO 14971, Calibration, CE marking, CQA, Technology Transfer, Testing, LIMS, Root Cause Analysis, Pharmaceutical Industry, Biotechnology
Education
California State University-Sacramento 1997 — 2000
BS, Health Sciences, Business
Lynn Spartz's Maetrics, LLC Experience June 2002 - February 2012
Job Account Executive at CSpring
Industry Information Technology and Services
Experience
CSpring January 2014 - Present
Fusion Alliance May 2012 - January 2014
Maetrics, LLC June 2002 - February 2012
Whittman-Hart May 1995 - October 1999
Skills
Business Development, Strategic Planning, New Business Development, Program Management, Cross-functional Team..., Entrepreneurship, Leadership, Process Improvement, Project Management, Team Building, Management, Start-ups, Strategy, Sales Process, Solution Selling, Recruiting, Team Leadership, Account Management
Education
Purdue University
Bachelor's Degree
CSpring January 2014 - Present
Fusion Alliance May 2012 - January 2014
Maetrics, LLC June 2002 - February 2012
Whittman-Hart May 1995 - October 1999
Skills
Business Development, Strategic Planning, New Business Development, Program Management, Cross-functional Team..., Entrepreneurship, Leadership, Process Improvement, Project Management, Team Building, Management, Start-ups, Strategy, Sales Process, Solution Selling, Recruiting, Team Leadership, Account Management
Education
Purdue University
Bachelor's Degree
Andy McGuire's Maetrics, LLC Experience November 2012 - November 2013
Job Director Operations Learning & Development at The Mosaic Company
Industry Professional Training & Coaching
Experience
Maetrics, LLC November 2012 - November 2013
ITT Educational Services, Inc. June 2012 - October 2012
Cummins Inc. June 2007 - May 2012
Roche Diagnostics January 2005 - May 2007
Hill-Rom, Inc. June 2002 - October 2004
Eli Lilly 1992 - 2002
Clemson Univeristy January 1990 - June 1992
AT&T 1989 - 1989
Skills
Learning and Development, Talent Management, Employee Development, Performance Management, Leadership Development, Organizational..., Performnce Consulting, Human Performance..., Competency Management, Change Management, Succession Planning, Process Improvement, ADDIE, PADDIEM, Front-end Analysis, Needs Analysis, Instructional Design, Training Evaluation and..., E-Learning, Distance Learning, Learning Management, Learning Management..., Project Management, Vendor Management, Six Sigma, Training, Quality Systems Training, Training for ERP Systems, Budget Planning and..., Strategic Planning, Business Planning, Management, Evaluation, Project Planning, Budgets, Cross-functional Team..., Performance Improvement, Coaching, Performance Consulting, Front-end, Team Building, Program Management, Business Process, Business Strategy, Strategic Leadership, Blended Learning, Leadership, Employee Training, Training Delivery, Employee Engagement
Education
Indiana University Bloomington 1987 — 1989
Master's degree, Instructional Systems Technology
Maetrics, LLC November 2012 - November 2013
ITT Educational Services, Inc. June 2012 - October 2012
Cummins Inc. June 2007 - May 2012
Roche Diagnostics January 2005 - May 2007
Hill-Rom, Inc. June 2002 - October 2004
Eli Lilly 1992 - 2002
Clemson Univeristy January 1990 - June 1992
AT&T 1989 - 1989
Skills
Learning and Development, Talent Management, Employee Development, Performance Management, Leadership Development, Organizational..., Performnce Consulting, Human Performance..., Competency Management, Change Management, Succession Planning, Process Improvement, ADDIE, PADDIEM, Front-end Analysis, Needs Analysis, Instructional Design, Training Evaluation and..., E-Learning, Distance Learning, Learning Management, Learning Management..., Project Management, Vendor Management, Six Sigma, Training, Quality Systems Training, Training for ERP Systems, Budget Planning and..., Strategic Planning, Business Planning, Management, Evaluation, Project Planning, Budgets, Cross-functional Team..., Performance Improvement, Coaching, Performance Consulting, Front-end, Team Building, Program Management, Business Process, Business Strategy, Strategic Leadership, Blended Learning, Leadership, Employee Training, Training Delivery, Employee Engagement
Education
Indiana University Bloomington 1987 — 1989
Master's degree, Instructional Systems Technology
Steve Jean-Philippe's Maetrics, LLC Experience April 2013 - Present
Job QUALITY CONSULTANT AT MAETRICS, LLC
Industry Medical Devices
Experience
Maetrics, LLC April 2013 - Present
AAR Landing Gear Services August 2009 - April 2013
Maetrics April 2013 - 2013
Beckman Coulter November 1981 - January 2009
Beckman Coulter 1981 - 2009
Skills
ISO 13485, CAPA, Quality System, FDA, GMP, Quality Auditing, ISO, Quality Assurance, TQM, Complaint Management, Manufacturing, Process Improvement, Biomedical Engineering, Management Review, Auditing, Design Control, Medical Devices, Internal Audit, 14 CFR Part 43 & 145, 21CFR Part 820, ISO 9000, AS9100, Validation, Iso 9000
Education
Nova Southeastern University 1993 — 1996
BS, Business & Professional Management
Maetrics, LLC April 2013 - Present
AAR Landing Gear Services August 2009 - April 2013
Maetrics April 2013 - 2013
Beckman Coulter November 1981 - January 2009
Beckman Coulter 1981 - 2009
Skills
ISO 13485, CAPA, Quality System, FDA, GMP, Quality Auditing, ISO, Quality Assurance, TQM, Complaint Management, Manufacturing, Process Improvement, Biomedical Engineering, Management Review, Auditing, Design Control, Medical Devices, Internal Audit, 14 CFR Part 43 & 145, 21CFR Part 820, ISO 9000, AS9100, Validation, Iso 9000
Education
Nova Southeastern University 1993 — 1996
BS, Business & Professional Management
Steven Wallace Steven Wallace's Maetrics, LLC Experience May 2013 - Present
Job Manager, Solutions Delivery at Maetrics, LLC
Industry Medical Devices
Experience
Maetrics, LLC May 2013 - Present
Thomas & Betts April 2013 - May 2013
Mission Health Systems, Inc January 2013 - May 2013
Medtronic Spine & Biologics August 2010 - November 2012
Medtronic Spine & Biologics February 2009 - August 2010
Independent Consultant May 2006 - March 2009
QinetiQ North America December 2008 - February 2009
Asurion April 2008 - January 2009
AIM Healthcare Services, Inc. May 2007 - April 2008
Harris Connect May 2006 - March 2007
Skills
Process Improvement, Cross-functional Team..., Six Sigma, Lean Manufacturing, Quality Assurance, FDA, Medical Devices, Quality Management, Continuous Improvement, Quality System, Product Development, Manufacturing, Leadership, DMAIC, Program Management, Project Management, Kaizen, Design of Experiments, FMEA, Data Analysis, Business Process..., 5S, Engineering, Innovation Development
Education
Middle Tennessee State University 1998 — 2002
MBA, Business Adminstration
Virginia Polytechnic Institute and State University 1990 — 1995
B.S., Industrial Engineering
Maetrics, LLC May 2013 - Present
Thomas & Betts April 2013 - May 2013
Mission Health Systems, Inc January 2013 - May 2013
Medtronic Spine & Biologics August 2010 - November 2012
Medtronic Spine & Biologics February 2009 - August 2010
Independent Consultant May 2006 - March 2009
QinetiQ North America December 2008 - February 2009
Asurion April 2008 - January 2009
AIM Healthcare Services, Inc. May 2007 - April 2008
Harris Connect May 2006 - March 2007
Skills
Process Improvement, Cross-functional Team..., Six Sigma, Lean Manufacturing, Quality Assurance, FDA, Medical Devices, Quality Management, Continuous Improvement, Quality System, Product Development, Manufacturing, Leadership, DMAIC, Program Management, Project Management, Kaizen, Design of Experiments, FMEA, Data Analysis, Business Process..., 5S, Engineering, Innovation Development
Education
Middle Tennessee State University 1998 — 2002
MBA, Business Adminstration
Virginia Polytechnic Institute and State University 1990 — 1995
B.S., Industrial Engineering
Donna Vieth's Maetrics, LLC Experience December 2011 - Present
Job CQT Consultant at Maetrics, LLC
Industry Medical Devices
Experience
Maetrics, LLC December 2011 - Present
Vieth Consulting December 2010 - Present
MicroCHIPS June 2007 - December 2010
Boston Scientific June 2005 - February 2007
Hospira, Inc. (formerly a division of Abbott Labs) May 2003 - June 2005
Abbott Laboratories 1998 - May 2003
Abbott Laboratories February 2001 - November 2001
Abbott Laboratories April 1998 - February 2001
Abbott Laboratories May 1996 - April 1998
New York Life Insurance Company 1991 - 1995
Skills
Technical Writing, Instructional Design, Auditing, Procedure Development, GMP, Training & Development, Work Instructions, InDesign, Visio, ISO 13485, 21 CFR Part 11, Documentation, Software Documentation, CAPA, Employee Training, Cross-functional Team..., Medical Devices, Quality Assurance, Quality System, Validation, Process Improvement, Sop, Manufacturing, R&D, FDA
Education
ISO 13485 Lead Auditor Certificate 2011 — 2011
Boise State University 2003 — 2005
MS, Instructional and Performance Technology
University of Maryland University College 1998 — 2001
BS Communication Studies, Business and Technical Communications
Grossmont College 1990 — 1996
N/A, Multimedia & Computer Science
Maetrics, LLC December 2011 - Present
Vieth Consulting December 2010 - Present
MicroCHIPS June 2007 - December 2010
Boston Scientific June 2005 - February 2007
Hospira, Inc. (formerly a division of Abbott Labs) May 2003 - June 2005
Abbott Laboratories 1998 - May 2003
Abbott Laboratories February 2001 - November 2001
Abbott Laboratories April 1998 - February 2001
Abbott Laboratories May 1996 - April 1998
New York Life Insurance Company 1991 - 1995
Skills
Technical Writing, Instructional Design, Auditing, Procedure Development, GMP, Training & Development, Work Instructions, InDesign, Visio, ISO 13485, 21 CFR Part 11, Documentation, Software Documentation, CAPA, Employee Training, Cross-functional Team..., Medical Devices, Quality Assurance, Quality System, Validation, Process Improvement, Sop, Manufacturing, R&D, FDA
Education
ISO 13485 Lead Auditor Certificate 2011 — 2011
Boise State University 2003 — 2005
MS, Instructional and Performance Technology
University of Maryland University College 1998 — 2001
BS Communication Studies, Business and Technical Communications
Grossmont College 1990 — 1996
N/A, Multimedia & Computer Science
Jacob Foster, MBA Jacob Foster, MBA's Maetrics, LLC Experience August 2012 - January 2015
Job Director, Solutions Delivery at MAETRICS
Industry Medical Devices
Experience
MAETRICS July 2015 - Present
MAETRICS January 2015 - July 2015
Maetrics, LLC August 2012 - January 2015
Maetrics, LLC September 2011 - August 2012
OPKO Health November 2010 - September 2011
Perrigo Florida (formerly Unico Holdings, Inc.) January 2007 - August 2010
Maetrics, LLC 2004 - 2006
Eli Lilly August 2003 - December 2004
Schweizerhall Manufacturing Company 1998 - 2000
Skills
GMP, Quality Systems, Auditing, ISO 13485, FDA, Quality System, ISO, Sop, CAPA, Validation, Quality Assurance, Design Control, Medical Devices, Quality Auditing, Quality Management, 21 CFR Part 11, Computer System..., Regulatory Affairs, Software Documentation, FMEA, Continuous Improvement, Pharmaceutical Industry, ISO 14971, Design of Experiments, Manufacturing, V&V, Process Engineering, Cross-functional Team..., Leadership, Root Cause Analysis, Quality Control, Change Control, Organizational..., Biotechnology, Laboratory, Testing, Process Simulation, Technology Transfer, SPC, DMAIC, GLP, Biopharmaceuticals, Document Management, 21 CFR, FDA GMP, Minitab, Six Sigma, R&D, GxP, Iso 9000
Education
Grand Canyon University 2008 — 2011
MBA (Six Sigma), Six Sigma
University of Louisville 1994 — 1996
BS, Chemistry
Clemson University 1992 — 1994
Chemical Engineering
Georgia Institute of Technology 1987 — 1991
Chemical Engineering
MAETRICS July 2015 - Present
MAETRICS January 2015 - July 2015
Maetrics, LLC August 2012 - January 2015
Maetrics, LLC September 2011 - August 2012
OPKO Health November 2010 - September 2011
Perrigo Florida (formerly Unico Holdings, Inc.) January 2007 - August 2010
Maetrics, LLC 2004 - 2006
Eli Lilly August 2003 - December 2004
Schweizerhall Manufacturing Company 1998 - 2000
Skills
GMP, Quality Systems, Auditing, ISO 13485, FDA, Quality System, ISO, Sop, CAPA, Validation, Quality Assurance, Design Control, Medical Devices, Quality Auditing, Quality Management, 21 CFR Part 11, Computer System..., Regulatory Affairs, Software Documentation, FMEA, Continuous Improvement, Pharmaceutical Industry, ISO 14971, Design of Experiments, Manufacturing, V&V, Process Engineering, Cross-functional Team..., Leadership, Root Cause Analysis, Quality Control, Change Control, Organizational..., Biotechnology, Laboratory, Testing, Process Simulation, Technology Transfer, SPC, DMAIC, GLP, Biopharmaceuticals, Document Management, 21 CFR, FDA GMP, Minitab, Six Sigma, R&D, GxP, Iso 9000
Education
Grand Canyon University 2008 — 2011
MBA (Six Sigma), Six Sigma
University of Louisville 1994 — 1996
BS, Chemistry
Clemson University 1992 — 1994
Chemical Engineering
Georgia Institute of Technology 1987 — 1991
Chemical Engineering
Anthony Loll Anthony Loll's Maetrics, LLC Experience Director of Quality & SafetyRAM Industrial Services, Inc.January 2012 - December 2012
Job Quality Engineer
Industry Medical Devices
Experience
Maetrics, LLC Director of Quality & SafetyRAM Industrial Services, Inc.January 2012 - December 2012
Haemonetics August 2011 - December 2012
Teleflex International June 2010 - December 2010
Billet Industries, Inc. November 2009 - August 2010
Unilife Medical Solutions February 2005 - July 2009
GE Hybrid Power Systems October 1996 - June 1999
Unocal Oil Company October 1988 - September 1996
Skills
Process Validation, QMS Development, Quality Management, ISO 13485, Medical Devices, Quality System, Sop, Testing, V, Validation, CAPA, FDA, R, GMP, Quality Control, SOP, Manufacturing, Quality Assurance
Education
Saddleback College
Associates, Chemistry
Maetrics, LLC Director of Quality & SafetyRAM Industrial Services, Inc.January 2012 - December 2012
Haemonetics August 2011 - December 2012
Teleflex International June 2010 - December 2010
Billet Industries, Inc. November 2009 - August 2010
Unilife Medical Solutions February 2005 - July 2009
GE Hybrid Power Systems October 1996 - June 1999
Unocal Oil Company October 1988 - September 1996
Skills
Process Validation, QMS Development, Quality Management, ISO 13485, Medical Devices, Quality System, Sop, Testing, V, Validation, CAPA, FDA, R, GMP, Quality Control, SOP, Manufacturing, Quality Assurance
Education
Saddleback College
Associates, Chemistry
Rebecca DeBoer Rebecca DeBoer's Maetrics, LLC Experience October 2008 - November 2009
Job Business Professional
Industry Pharmaceuticals
Experience
Maetrics, LLC October 2008 - November 2009
sanofi-aventis December 2005 - September 2008
Sharon Lynne Wilson Center for the Arts September 2004 - February 2005
VMS September 2001 - September 2004
PricewaterhouseCoopers September 1999 - May 2001
Skills
Management, Business Development, Account Management, Strategic Planning, Leadership, Medical Devices, Pharmaceutical Industry, Cross-functional Team...
Education
Michigan State University 1995 — 1999
Bachelor of Arts
Maetrics, LLC October 2008 - November 2009
sanofi-aventis December 2005 - September 2008
Sharon Lynne Wilson Center for the Arts September 2004 - February 2005
VMS September 2001 - September 2004
PricewaterhouseCoopers September 1999 - May 2001
Skills
Management, Business Development, Account Management, Strategic Planning, Leadership, Medical Devices, Pharmaceutical Industry, Cross-functional Team...
Education
Michigan State University 1995 — 1999
Bachelor of Arts
Randall Gasa Randall Gasa's Maetrics, LLC Experience May 2009 - May 2015
Job Director Life Sciences Quality and Compliance at Smart Life Sciences
Industry Management Consulting
Experience
Smart Life Sciences June 2015 - Present
Maetrics, LLC May 2009 - May 2015
Maetrics, LLC November 2007 - May 2009
JOM Pharmaceutical services September 2007 - November 2007
Brock Solutions May 2006 - September 2007
Maetrics, LLC September 2004 - May 2006
Eli Lilly and Company February 2004 - September 2004
Abbott Laboratories 2000 - 2001
Argonne National Laboratory 1996 - 1996
Skills
Validation, Quality System, CAPA, 21 CFR Part 11, FDA, Computer System..., ISO 13485, GMP, Medical Devices, FMEA, Batch Records, Sop, ISO 14971, Change Control, V&V, Quality Assurance, Design Control, GAMP, GxP, Quality Auditing, Quality Control, SOP, Root Cause Analysis, Cross-functional Team...
Education
Ohio University
Bachelor of Science, Chemical Engineering
OPRF
Smart Life Sciences June 2015 - Present
Maetrics, LLC May 2009 - May 2015
Maetrics, LLC November 2007 - May 2009
JOM Pharmaceutical services September 2007 - November 2007
Brock Solutions May 2006 - September 2007
Maetrics, LLC September 2004 - May 2006
Eli Lilly and Company February 2004 - September 2004
Abbott Laboratories 2000 - 2001
Argonne National Laboratory 1996 - 1996
Skills
Validation, Quality System, CAPA, 21 CFR Part 11, FDA, Computer System..., ISO 13485, GMP, Medical Devices, FMEA, Batch Records, Sop, ISO 14971, Change Control, V&V, Quality Assurance, Design Control, GAMP, GxP, Quality Auditing, Quality Control, SOP, Root Cause Analysis, Cross-functional Team...
Education
Ohio University
Bachelor of Science, Chemical Engineering
OPRF
Don Henderson Don Henderson's Maetrics, LLC Experience August 2013 - April 2015
Job President at Apex Quality Consulting Group
Industry Medical Devices
Experience
Apex Quality Consulting Group April 2015 - Present
Maetrics, LLC August 2013 - April 2015
Emergo Group April 2013 - April 2015
Oxford Global Resources April 2012 - July 2013
Conmed Corporation July 2010 - September 2011
Epimed International 1996 - 2008
Epimed International 1992 - 1996
Skills
ISO 13485, FDA, CE marking, Medical Devices, V&V, CAPA, Design Control, Quality System, Regulatory Affairs, Validation, Complaint Management, Regulatory Submissions, Quality Auditing, Quality Assurance, Biotechnology, ISO, Iso 9000, Lifesciences, Life Sciences, ISO 9000
Education
State University of New York College at Plattsburgh 1986 — 1991
Bachelor of Science (BS), Business, Management, Marketing, and Related Support Services
Apex Quality Consulting Group April 2015 - Present
Maetrics, LLC August 2013 - April 2015
Emergo Group April 2013 - April 2015
Oxford Global Resources April 2012 - July 2013
Conmed Corporation July 2010 - September 2011
Epimed International 1996 - 2008
Epimed International 1992 - 1996
Skills
ISO 13485, FDA, CE marking, Medical Devices, V&V, CAPA, Design Control, Quality System, Regulatory Affairs, Validation, Complaint Management, Regulatory Submissions, Quality Auditing, Quality Assurance, Biotechnology, ISO, Iso 9000, Lifesciences, Life Sciences, ISO 9000
Education
State University of New York College at Plattsburgh 1986 — 1991
Bachelor of Science (BS), Business, Management, Marketing, and Related Support Services
Randall K Lenz, MBA Randall K Lenz, MBA's Maetrics, LLC Experience February 2011 - July 2012
Job Quality System Program Manager at Oxford Global Resources (Covidien Medtronic)
Industry Medical Devices
Experience
Oxford Global Resources (Covidien GI Solutions part of Medtronic) May 2015 - Present
Orion Consulting Group, LLC June 2012 - Present
American Contractors Corp. April 2015 - May 2015
Validant September 2014 - December 2014
Validant May 2014 - August 2014
Black Diamond Networks January 2014 - March 2014
The Evanston Group August 2012 - December 2013
Maetrics, LLC February 2011 - July 2012
Maetrics, LLC - Compliance, Quality & Technology Consultants September 2009 - February 2011
Maetrics, LLC September 2009 - October 2009
Skills
Analytics, Asset Managment, Auditing, Budgeting, Continuous Improvement, cGMP manufacturing, Business, Business Development, Customer Service, Configuration Management, Entrepreneurship, ISO, iPhone, Key Account Development, Kaizen, Leadership, Lifesciences, Medical Devices, Microsoft Office, Microsoft Excel, Microsoft Word, Mathematics, Non-profits, Outsourcing, Organization, PowerPoint, PMP, Problem Solving, Quality Assurance, Quality Management, Quality System, Regulatory Affairs, Sustainability, SOA, Visio, Program Management, FDA, Manufacturing, Budgets, Nonprofits, SPC, Cross-functional Team..., Process Improvement
Education
Cornerstone University 2008 — 2009
M.B.A., Business Administration - (international emphasis)
Michigan State University 1985 — 1989
B.S., Physical Science (mathematics / engineering)
Michigan Technological University 1983 — 1984
Undergrad Studies, Computer Science & Engineering, Freshmen & Sophomore
Harrison High School 1980 — 1983
Diploma, Math and Sciences
Oxford Global Resources (Covidien GI Solutions part of Medtronic) May 2015 - Present
Orion Consulting Group, LLC June 2012 - Present
American Contractors Corp. April 2015 - May 2015
Validant September 2014 - December 2014
Validant May 2014 - August 2014
Black Diamond Networks January 2014 - March 2014
The Evanston Group August 2012 - December 2013
Maetrics, LLC February 2011 - July 2012
Maetrics, LLC - Compliance, Quality & Technology Consultants September 2009 - February 2011
Maetrics, LLC September 2009 - October 2009
Skills
Analytics, Asset Managment, Auditing, Budgeting, Continuous Improvement, cGMP manufacturing, Business, Business Development, Customer Service, Configuration Management, Entrepreneurship, ISO, iPhone, Key Account Development, Kaizen, Leadership, Lifesciences, Medical Devices, Microsoft Office, Microsoft Excel, Microsoft Word, Mathematics, Non-profits, Outsourcing, Organization, PowerPoint, PMP, Problem Solving, Quality Assurance, Quality Management, Quality System, Regulatory Affairs, Sustainability, SOA, Visio, Program Management, FDA, Manufacturing, Budgets, Nonprofits, SPC, Cross-functional Team..., Process Improvement
Education
Cornerstone University 2008 — 2009
M.B.A., Business Administration - (international emphasis)
Michigan State University 1985 — 1989
B.S., Physical Science (mathematics / engineering)
Michigan Technological University 1983 — 1984
Undergrad Studies, Computer Science & Engineering, Freshmen & Sophomore
Harrison High School 1980 — 1983
Diploma, Math and Sciences
Amit N. Patel, CQA, CQMS-PA Amit N. Patel, CQA, CQMS-PA's Maetrics, LLC Experience January 2013 - November 2014
Job Principal Consultant at Pal Management Consulting LLC
Industry Medical Devices
Experience
Pal Management Consulting LLC July 2015 - Present
Oxford Global Resources September 2014 - July 2015
Maetrics, LLC January 2013 - November 2014
Hercon Pharmaceuticals August 2014 - September 2014
Hospira (Contractor) September 2012 - January 2013
Pfizer November 2011 - August 2012
sanofi-aventis August 2011 - November 2011
Blispak Inc. June 2011 - August 2011
Astral Pharmaceutical Ind September 2010 - February 2011
Claris Lifesciences Ltd March 2009 - August 2009
Skills
Document Review, CAPA, Validation, Change Control, Quality Auditing, Quality Systems, Investigations, Inspection, cGMP, Process Validation, GMP, Cleaning Validation, Quality Assurance, Compliance, Quality Management, Root Cause Analysis, Sop, V&V, Quality System, Software Documentation, Private Investigations, Gap Analysis, Trackwise, Pharmaceutics, Biotechnology, Analytical Chemistry, 21 CFR Part 11, Remedial Investigations, Regulatory Affairs, GxP, Regulatory Submissions, GLP, Computer System..., Technology Transfer, Pharmaceutical Industry, Aseptic Processing, Microbiology, LIMS, Biopharmaceuticals, GAMP, ISO 13485, Technical Writing, GCP, HPLC, Quality Control
Education
California State University-Dominguez Hills 2013 — 2014
Technical Writing Certificate, Technical Writing
The University of Chicago - Graham School 2013 — 2014
Medical Writing and Editing Certificate
Villanova University 2013 — 2013
Masters Certificate in Six Sigma, Six Sigma Green Belt, Lean Six Sigma, Six Sigma Black Belt
Institute of Pharmacy, Nirma University 2009 — 2010
Bachelor of Pharmacy (Hons.), Clinical Pharmacy, 3.07
Amravati University 2001 — 2005
B.Pharm, Pharmaceutical Sciences, 3.71
H. M. Patel EMSC 1997 — 2001
High School, Physics, Chemistry, Biology, Mathematics
English Teaching School 1992 — 1997
School, School
Pal Management Consulting LLC July 2015 - Present
Oxford Global Resources September 2014 - July 2015
Maetrics, LLC January 2013 - November 2014
Hercon Pharmaceuticals August 2014 - September 2014
Hospira (Contractor) September 2012 - January 2013
Pfizer November 2011 - August 2012
sanofi-aventis August 2011 - November 2011
Blispak Inc. June 2011 - August 2011
Astral Pharmaceutical Ind September 2010 - February 2011
Claris Lifesciences Ltd March 2009 - August 2009
Skills
Document Review, CAPA, Validation, Change Control, Quality Auditing, Quality Systems, Investigations, Inspection, cGMP, Process Validation, GMP, Cleaning Validation, Quality Assurance, Compliance, Quality Management, Root Cause Analysis, Sop, V&V, Quality System, Software Documentation, Private Investigations, Gap Analysis, Trackwise, Pharmaceutics, Biotechnology, Analytical Chemistry, 21 CFR Part 11, Remedial Investigations, Regulatory Affairs, GxP, Regulatory Submissions, GLP, Computer System..., Technology Transfer, Pharmaceutical Industry, Aseptic Processing, Microbiology, LIMS, Biopharmaceuticals, GAMP, ISO 13485, Technical Writing, GCP, HPLC, Quality Control
Education
California State University-Dominguez Hills 2013 — 2014
Technical Writing Certificate, Technical Writing
The University of Chicago - Graham School 2013 — 2014
Medical Writing and Editing Certificate
Villanova University 2013 — 2013
Masters Certificate in Six Sigma, Six Sigma Green Belt, Lean Six Sigma, Six Sigma Black Belt
Institute of Pharmacy, Nirma University 2009 — 2010
Bachelor of Pharmacy (Hons.), Clinical Pharmacy, 3.07
Amravati University 2001 — 2005
B.Pharm, Pharmaceutical Sciences, 3.71
H. M. Patel EMSC 1997 — 2001
High School, Physics, Chemistry, Biology, Mathematics
English Teaching School 1992 — 1997
School, School
Angela Young-Oliver's Maetrics, LLC Experience July 2012 - July 2013
Job Recruiter at Roche Diagnostics
Industry Medical Devices
Experience
Roche Diagnostics March 2015 - Present
IBM July 2013 - February 2015
Maetrics, LLC July 2012 - July 2013
ExactTarget February 2011 - July 2012
Vision Solutions (Formerly Double Take Software) October 2007 - February 2011
Kforce Technology Staffing May 2006 - October 2007
Thermo Fisher Scientific January 2005 - May 2006
Volt Technical Resources August 2002 - January 2005
TEKsystems 2001 - 2001
Skills
Applicant Tracking..., College Recruiting, Recruiting, Talent Acquisition, Technical Recruiting
Education
Indiana State University 1997 — 1999
Master's Program Criminal Justice
Indiana State University 1993 — 1997
B.S, Criminal Justice
Roche Diagnostics March 2015 - Present
IBM July 2013 - February 2015
Maetrics, LLC July 2012 - July 2013
ExactTarget February 2011 - July 2012
Vision Solutions (Formerly Double Take Software) October 2007 - February 2011
Kforce Technology Staffing May 2006 - October 2007
Thermo Fisher Scientific January 2005 - May 2006
Volt Technical Resources August 2002 - January 2005
TEKsystems 2001 - 2001
Skills
Applicant Tracking..., College Recruiting, Recruiting, Talent Acquisition, Technical Recruiting
Education
Indiana State University 1997 — 1999
Master's Program Criminal Justice
Indiana State University 1993 — 1997
B.S, Criminal Justice
Phyllis Neal, MBA's Maetrics, LLC Experience 2012 - February 2014
Job Quality Manager
Industry Medical Devices
Experience
Thermi June 2015 - Present
Cognizant Technology Solutions November 2014 - June 2015
OsteoMed March 2014 - November 2014
Maetrics, LLC 2012 - February 2014
Terumo Cardiovascular Systems October 2011 - March 2012
Abbott Laboratories (Retired) 2002 - December 2011
Abbott Laboratories 1997 - December 2002
Pharmchem Toxicology Laboratories 1992 - 1997
Skills
FDA, Quality System, ISO 13485, 21 CFR Part 11, CAPA, Validation, Design Control, Quality Assurance, GMP, Microsoft Office, Six Sigma, Cross-functional Team..., Testing, Corrective Action, Software Documentation, V&V, Corrective Actions, Manufacturing, Complaint Management, Microsoft Office 2007, Microsoft, NCMR, NIDA
Education
Project Management Academy 2011 — 2011
Project Management
Kaplan University 2005 — 2007
MBA, Business, 3.97
Wiley College 1977 — 1981
BS, Biology
Thermi June 2015 - Present
Cognizant Technology Solutions November 2014 - June 2015
OsteoMed March 2014 - November 2014
Maetrics, LLC 2012 - February 2014
Terumo Cardiovascular Systems October 2011 - March 2012
Abbott Laboratories (Retired) 2002 - December 2011
Abbott Laboratories 1997 - December 2002
Pharmchem Toxicology Laboratories 1992 - 1997
Skills
FDA, Quality System, ISO 13485, 21 CFR Part 11, CAPA, Validation, Design Control, Quality Assurance, GMP, Microsoft Office, Six Sigma, Cross-functional Team..., Testing, Corrective Action, Software Documentation, V&V, Corrective Actions, Manufacturing, Complaint Management, Microsoft Office 2007, Microsoft, NCMR, NIDA
Education
Project Management Academy 2011 — 2011
Project Management
Kaplan University 2005 — 2007
MBA, Business, 3.97
Wiley College 1977 — 1981
BS, Biology
Lori Zelenitz Swisher's Maetrics, LLC Experience April 2008 - December 2010
Job National Sales Director at LexaMed, Ltd.
Industry Medical Devices
Experience
LexaMed February 2014 - Present
Synergy Health July 2012 - December 2013
Medtronic December 2011 - July 2012
Validant December 2010 - December 2011
Maetrics LLC April 2008 - December 2010
LexaMed November 2007 - April 2008
J & J Scientific Products February 2007 - December 2007
Baxter Healthcare February 2005 - January 2007
MasterTaste November 2003 - December 2004
ASO Corporation June 2001 - November 2003
Skills
CAPA, Validation, FDA, ISO 13485, Medical Devices, V&V, Quality System, FMEA, Manufacturing, Regulatory Affairs, Continuous Improvement, Quality Assurance, SPC, ISO, Sop, Quality Auditing, Change Control, GMP
Education
Gannon University 1981 — 1985
Bachelor of Science, Biology
LexaMed February 2014 - Present
Synergy Health July 2012 - December 2013
Medtronic December 2011 - July 2012
Validant December 2010 - December 2011
Maetrics LLC April 2008 - December 2010
LexaMed November 2007 - April 2008
J & J Scientific Products February 2007 - December 2007
Baxter Healthcare February 2005 - January 2007
MasterTaste November 2003 - December 2004
ASO Corporation June 2001 - November 2003
Skills
CAPA, Validation, FDA, ISO 13485, Medical Devices, V&V, Quality System, FMEA, Manufacturing, Regulatory Affairs, Continuous Improvement, Quality Assurance, SPC, ISO, Sop, Quality Auditing, Change Control, GMP
Education
Gannon University 1981 — 1985
Bachelor of Science, Biology
Don Amig Don Amig's Maetrics, LLC Experience March 2013 - December 2014
Job Management Consultant at Oxford International
Industry Pharmaceuticals
Experience
Oxford International July 2015 - Present
PharmaBio Serv June 2015 - July 2015
Maetrics, LLC March 2013 - December 2014
Validant July 2012 - March 2013
Piramal Critical Care, Inc October 2010 - June 2012
Validant March 2010 - October 2010
Halo Pharmaceuticals, Inc. January 2009 - April 2010
Abbott Laboratories August 2003 - December 2008
Skills
Quality Management, Quality Systems Design, Quality System..., cGMP practices, CFR Part 210 & 211, CFR 21 Part 820, ISO 13485, Quality Auditing, ICH guidelines, Validation, FDA, Quality Assurance, FDA GMP, Quality Control, Quality System, GxP, CAPA, GMP, Six Sigma, Medical Devices, Root Cause Analysis, Cross-functional Team..., 21 CFR Part 11, Pharmaceutical Industry, Regulatory Affairs, SOP, Change Control, GLP, V&V, Process Improvement
Education
Lehigh University - College of Business and Economics 1997 — 2002
MBA, General Administration
Penn State University 1968 — 1972
Bachelor's degree, Ceramic Sciences and Engineering
Oxford International July 2015 - Present
PharmaBio Serv June 2015 - July 2015
Maetrics, LLC March 2013 - December 2014
Validant July 2012 - March 2013
Piramal Critical Care, Inc October 2010 - June 2012
Validant March 2010 - October 2010
Halo Pharmaceuticals, Inc. January 2009 - April 2010
Abbott Laboratories August 2003 - December 2008
Skills
Quality Management, Quality Systems Design, Quality System..., cGMP practices, CFR Part 210 & 211, CFR 21 Part 820, ISO 13485, Quality Auditing, ICH guidelines, Validation, FDA, Quality Assurance, FDA GMP, Quality Control, Quality System, GxP, CAPA, GMP, Six Sigma, Medical Devices, Root Cause Analysis, Cross-functional Team..., 21 CFR Part 11, Pharmaceutical Industry, Regulatory Affairs, SOP, Change Control, GLP, V&V, Process Improvement
Education
Lehigh University - College of Business and Economics 1997 — 2002
MBA, General Administration
Penn State University 1968 — 1972
Bachelor's degree, Ceramic Sciences and Engineering
Hai Yang's Maetrics, LLC Experience January 2013 - June 2014
Job
Industry Medical Devices
Experience
Siemens Healthcare 2015 - Present
Biomet 2014 - 2015
Maetrics, LLC January 2013 - June 2014
Covance July 2009 - December 2012
Maetrics, LLC January 2008 - June 2009
Skills
FDA, Medical Devices, Validation, Quality System, Clinical Trials, Microbiology, Quality Control, GCP, Clinical Data Management, Software Documentation, Clinical Research, CAPA, LIMS, CRO, Clinical Chemistry, Medical Device Recalls, Risk Analyses (Medical..., Investigations, Post Market Surveillance, Presentations, Quality Assurance, Cross-functional Team..., Process Improvement, Pharmaceutical Industry, ISO 13485
Education
Ball State University 2002 — 2007
Bachelors
Siemens Healthcare 2015 - Present
Biomet 2014 - 2015
Maetrics, LLC January 2013 - June 2014
Covance July 2009 - December 2012
Maetrics, LLC January 2008 - June 2009
Skills
FDA, Medical Devices, Validation, Quality System, Clinical Trials, Microbiology, Quality Control, GCP, Clinical Data Management, Software Documentation, Clinical Research, CAPA, LIMS, CRO, Clinical Chemistry, Medical Device Recalls, Risk Analyses (Medical..., Investigations, Post Market Surveillance, Presentations, Quality Assurance, Cross-functional Team..., Process Improvement, Pharmaceutical Industry, ISO 13485
Education
Ball State University 2002 — 2007
Bachelors
Adam J. Welch's Maetrics, LLC Experience April 2013 - July 2014
Job Operations Manager at McRoberts Security Technologies
Industry Medical Devices
Experience
Steri-Kit/McRoberts Security Technologies, Inc October 2014 - Present
Maetrics, LLC April 2013 - July 2014
Intuitive Surgical July 2012 - September 2012
Stryker Endoscopy July 2009 - July 2012
Muscular Dystrophy Association 2009 - 2009
Skills
CAPA, ISO 13485, FDA, Curriculum Development, Volunteer Management, Volunteer Recruiting, Volunteer Training, Lean Manufacturing, Complaint Management, Regulatory Affairs, Quality System, Quality Auditing, Root Cause Analysis, Validation, Medical Devices, Public Speaking, Management, Research, Quality Assurance, Training, SOP, Operations Management, Production Planning
Education
San Jose State University 2007 — 2009
BA Social Sciences, History, Education
Steri-Kit/McRoberts Security Technologies, Inc October 2014 - Present
Maetrics, LLC April 2013 - July 2014
Intuitive Surgical July 2012 - September 2012
Stryker Endoscopy July 2009 - July 2012
Muscular Dystrophy Association 2009 - 2009
Skills
CAPA, ISO 13485, FDA, Curriculum Development, Volunteer Management, Volunteer Recruiting, Volunteer Training, Lean Manufacturing, Complaint Management, Regulatory Affairs, Quality System, Quality Auditing, Root Cause Analysis, Validation, Medical Devices, Public Speaking, Management, Research, Quality Assurance, Training, SOP, Operations Management, Production Planning
Education
San Jose State University 2007 — 2009
BA Social Sciences, History, Education
Thomas Stilson, BSME Thomas Stilson, BSME's Maetrics, LLC Experience December 2010 - June 2014
Job QA Engineer Risk Management at Stryker
Industry Medical Devices
Experience
Stryker July 2014 - Present
Maetrics, LLC December 2010 - June 2014
Western Michigan University August 2008 - December 2008
Corium International March 2004 - April 2007
Skills
FDA, CAPA, Quality Assurance, Medical Devices, Root Cause Analysis, ISO 14971, ISO, Quality System, Pro Engineer, Solidworks, Risk Assessment, Risk Management, Risk Analysis, MathCAD, FDA GMP, Trackwise, FMEA, Quality Management, Quality Auditing, Continuous Improvement, Validation, Quality Control, Matlab, Auditing, Microsoft Office, Microsoft Excel, Visio, Complaint Investigations, Compliance
Education
Western Michigan University 2007 — 2010
Bachelor of Science (BS), Mechanical Engineering
Grand Rapids Community College 2003 — 2007
Associate of Science (AS), Pre-Engineering
Stryker July 2014 - Present
Maetrics, LLC December 2010 - June 2014
Western Michigan University August 2008 - December 2008
Corium International March 2004 - April 2007
Skills
FDA, CAPA, Quality Assurance, Medical Devices, Root Cause Analysis, ISO 14971, ISO, Quality System, Pro Engineer, Solidworks, Risk Assessment, Risk Management, Risk Analysis, MathCAD, FDA GMP, Trackwise, FMEA, Quality Management, Quality Auditing, Continuous Improvement, Validation, Quality Control, Matlab, Auditing, Microsoft Office, Microsoft Excel, Visio, Complaint Investigations, Compliance
Education
Western Michigan University 2007 — 2010
Bachelor of Science (BS), Mechanical Engineering
Grand Rapids Community College 2003 — 2007
Associate of Science (AS), Pre-Engineering
Christina McGuire Christina McGuire's Maetrics, LLC Experience January 2013 - October 2013
Job Principal Post Market Surveillance Specialist
Industry Medical Devices
Experience
Fresenius Medical Care November 2014 - Present
Validant August 2014 - November 2014
DOHMEN March 2014 - June 2014
Maetrics, LLC January 2013 - October 2013
HeartWare Inc March 2011 - March 2012
Cordis Corporation February 2005 - March 2011
Baxter Healthcare Corporation January 1999 - January 2001
Skills
Medical Devices, Validation, ISO 13485, FDA, Quality System, Quality Assurance, CAPA, Quality Management, 21 CFR, GMP, ISO 14971, V, Complaint Management, Software Documentation, Sop, V&V, Regulatory Affairs
Education
Florida International University 2006 — 2008
Bachelors, International Business and Management
Fresenius Medical Care November 2014 - Present
Validant August 2014 - November 2014
DOHMEN March 2014 - June 2014
Maetrics, LLC January 2013 - October 2013
HeartWare Inc March 2011 - March 2012
Cordis Corporation February 2005 - March 2011
Baxter Healthcare Corporation January 1999 - January 2001
Skills
Medical Devices, Validation, ISO 13485, FDA, Quality System, Quality Assurance, CAPA, Quality Management, 21 CFR, GMP, ISO 14971, V, Complaint Management, Software Documentation, Sop, V&V, Regulatory Affairs
Education
Florida International University 2006 — 2008
Bachelors, International Business and Management
Sarah Mott, CMQ/OE, CQA Sarah Mott, CMQ/OE, CQA's Maetrics, LLC Experience March 2014 - July 2014
Job Manager at MAETRICS
Industry Medical Devices
Experience
MAETRICS 2015 - Present
MAETRICS July 2013 - Present
MAETRICS August 2014 - December 2014
MAETRICS, LLC March 2014 - July 2014
Pii (Pharmaceutics International, Inc.). January 2010 - June 2013
Housing Authority of Baltimore City November 2009 - January 2010
JP Morgan Chase July 2007 - May 2009
Abbott Bioresearch Center November 2000 - July 2007
Auto Credit Express December 1998 - November 2000
American Honda Finance 1996 - 1998
Skills
Training, CAPA, Change Control, Process Improvement, Quality System, Quality Assurance, Change Management, Auditing, Quality Management, Medical Devices, 21 CFR Part 11, FDA, Quality Auditing, GMP, Leadership, Management, Cross-functional Team..., Pharmaceutical Industry, Biotechnology, SOP, Project Management, Continuous Improvement, Regulatory Affairs, Consulting
Education
Franklin Pierce University 1993 — 1996
BA, Anthropology
University of Delaware 1994 — 1995
Anthropology, Linguistics
MAETRICS 2015 - Present
MAETRICS July 2013 - Present
MAETRICS August 2014 - December 2014
MAETRICS, LLC March 2014 - July 2014
Pii (Pharmaceutics International, Inc.). January 2010 - June 2013
Housing Authority of Baltimore City November 2009 - January 2010
JP Morgan Chase July 2007 - May 2009
Abbott Bioresearch Center November 2000 - July 2007
Auto Credit Express December 1998 - November 2000
American Honda Finance 1996 - 1998
Skills
Training, CAPA, Change Control, Process Improvement, Quality System, Quality Assurance, Change Management, Auditing, Quality Management, Medical Devices, 21 CFR Part 11, FDA, Quality Auditing, GMP, Leadership, Management, Cross-functional Team..., Pharmaceutical Industry, Biotechnology, SOP, Project Management, Continuous Improvement, Regulatory Affairs, Consulting
Education
Franklin Pierce University 1993 — 1996
BA, Anthropology
University of Delaware 1994 — 1995
Anthropology, Linguistics
Jerry Mickam Jerry Mickam's Maetrics, LLC Experience September 2013 - December 2014
Job Medical Device, Education/Training/Development, Regulatory, Project Management at Jerry Mickam, CSFA, LLC
Industry Medical Devices
Experience
Jerry Mickam, CSFA, LLC 2013 - Present
Maetrics, LLC September 2013 - December 2014
Medtronic July 2007 - September 2013
Medtronic July 2007 - October 2012
Medtronic July 2007 - June 2012
Medtronic ENT 2007 - November 2011
Spectrum Health September 1994 - July 2007
Spectrum Health September 1994 - July 2007
Baker College September 2002 - June 2007
Skills
Medical Devices, FDA, Regulatory Compliance, MDR Determinations, CAPA, 3500a, Corporate Integrity..., Surgery, ENT, Operating Room, Clinical Research, General Surgery, Neurology, Neurosurgery, Capital Equipment, Pharmacology, Orthopedic, Healthcare, Hospitals, Cardiology, Nursing, Sales, Training, Orthopedics, Teaching, Public Speaking, Project Management, Digital Imaging, Marketing, Technical Support, Process Scheduler, Academia, Newsletters, Leadership, Cross-functional Team..., Trust Building, Surgeons, Product Launch, Market Development, Surgical Instruments, Management, Urology, Career Development, Software Documentation, Image Guided Surgery, Spine, Disposables, Medicine, Sales Operations
Education
Saginaw Valley State University 1999 — 2000
BAS
Delta College, University 1998 — 1999
Associate of Applied Sciences
Baker College 1995 — 1997
Associate of Applied Sciences
Baker College of Muskegon 1994 — 1995
AAS
Ottawa Hills High School 1972 — 1976
Diploma
Jerry Mickam, CSFA, LLC 2013 - Present
Maetrics, LLC September 2013 - December 2014
Medtronic July 2007 - September 2013
Medtronic July 2007 - October 2012
Medtronic July 2007 - June 2012
Medtronic ENT 2007 - November 2011
Spectrum Health September 1994 - July 2007
Spectrum Health September 1994 - July 2007
Baker College September 2002 - June 2007
Skills
Medical Devices, FDA, Regulatory Compliance, MDR Determinations, CAPA, 3500a, Corporate Integrity..., Surgery, ENT, Operating Room, Clinical Research, General Surgery, Neurology, Neurosurgery, Capital Equipment, Pharmacology, Orthopedic, Healthcare, Hospitals, Cardiology, Nursing, Sales, Training, Orthopedics, Teaching, Public Speaking, Project Management, Digital Imaging, Marketing, Technical Support, Process Scheduler, Academia, Newsletters, Leadership, Cross-functional Team..., Trust Building, Surgeons, Product Launch, Market Development, Surgical Instruments, Management, Urology, Career Development, Software Documentation, Image Guided Surgery, Spine, Disposables, Medicine, Sales Operations
Education
Saginaw Valley State University 1999 — 2000
BAS
Delta College, University 1998 — 1999
Associate of Applied Sciences
Baker College 1995 — 1997
Associate of Applied Sciences
Baker College of Muskegon 1994 — 1995
AAS
Ottawa Hills High School 1972 — 1976
Diploma
Renan Estuardo Peña Renan Estuardo Peña's Maetrics, LLC Experience September 2013 - May 2014
Job Post Market Clinical and Pharmacovigilance Analyst – Team Lead at Oxford Global Resources
Industry Medical Devices
Experience
Oxford Global Resources June 2015 - Present
Black Diamond Networks February 2015 - July 2015
Validant May 2014 - December 2014
Maetrics, LLC September 2013 - May 2014
Medtronic May 2010 - September 2013
Skills
Medical Devices, Process Improvement, Troubleshooting, Software Documentation, FDA, Market Development, Customer Service, Management, Training, SAP, Cross-functional Team..., Quality System, Quality Assurance, CAPA, Six Sigma, GMP, Microsoft Office, Pharmaceutical Industry
Education
The University of Texas at San Antonio 2006 — 2012
Bachelor of Science (BS), Mechanical Engineering
Texas A&M University 2005 — 2006
Bachelor of Science (BS), Naval Architecture and Marine Engineering
Oxford Global Resources June 2015 - Present
Black Diamond Networks February 2015 - July 2015
Validant May 2014 - December 2014
Maetrics, LLC September 2013 - May 2014
Medtronic May 2010 - September 2013
Skills
Medical Devices, Process Improvement, Troubleshooting, Software Documentation, FDA, Market Development, Customer Service, Management, Training, SAP, Cross-functional Team..., Quality System, Quality Assurance, CAPA, Six Sigma, GMP, Microsoft Office, Pharmaceutical Industry
Education
The University of Texas at San Antonio 2006 — 2012
Bachelor of Science (BS), Mechanical Engineering
Texas A&M University 2005 — 2006
Bachelor of Science (BS), Naval Architecture and Marine Engineering
Luis Heredia, MSc Luis Heredia, MSc's Maetrics, LLC Experience December 2010 - August 2012
Job CQT Founder & Program Managing Director
Industry Management Consulting
Experience
CQT Consultancy, LLC August 2012 - Present
Maetrics, LLC December 2010 - August 2012
CR Bard Endovascular 2008 - January 2011
The Richline Group, a Berkshire Hathaway Company 2009 - 2010
DePuy, Johnson & Johnson 2003 - 2008
DePuy Johnson & Johnson 1999 - 2003
JJPI, Johnson & Johnson 1996 - 1999
Scully Signal Company November 1988 - October 1996
Skills
Medical Devices, Program Management, Six Sigma, Validation, Business Analysis, Change Control, Manufacturing, ERP, Testing, Product Development, Engineering, Strategic Planning, Microsoft Office, Integration, Software Project..., Analysis, PMP, Management Consulting, Requirements Analysis, Technical Leadership, FMEA, Healthcare, Compliance, Release Management, Contract Negotiation, PMO, Software Development..., Product Life Cycle..., Leading Projects, Readiness, Budgeting, Planning, Customer Relations, Mergers, Risk, Software Products, Policy, Product Requirements, Administration, Waterfall, Web Project Management, Project Execution, Life Cycle Assessment, People Management, Quality Systems, Virtual Teams, Cost, Deployment, PMI, EMEA
Education
Northeastern University 1995 — 1996
Post Graduate State of the Art Program, Computer Software Engineering
Nacional'nij Tehnicnij Universytet 'Kharkivskij Polytehnicnij Institut' 1986 — 1988
Master of Science, Computer Science
Nacional'nij Tehnicnij Universytet 'Kharkivskij Polytehnicnij Institut' 1981 — 1986
Bachelor of science, Electronics Systems Engineering
Universidad Autónoma de Santo Domingo 1979 — 1981
Engineering Fundamentals, Electromechanical Engineering
CQT Consultancy, LLC August 2012 - Present
Maetrics, LLC December 2010 - August 2012
CR Bard Endovascular 2008 - January 2011
The Richline Group, a Berkshire Hathaway Company 2009 - 2010
DePuy, Johnson & Johnson 2003 - 2008
DePuy Johnson & Johnson 1999 - 2003
JJPI, Johnson & Johnson 1996 - 1999
Scully Signal Company November 1988 - October 1996
Skills
Medical Devices, Program Management, Six Sigma, Validation, Business Analysis, Change Control, Manufacturing, ERP, Testing, Product Development, Engineering, Strategic Planning, Microsoft Office, Integration, Software Project..., Analysis, PMP, Management Consulting, Requirements Analysis, Technical Leadership, FMEA, Healthcare, Compliance, Release Management, Contract Negotiation, PMO, Software Development..., Product Life Cycle..., Leading Projects, Readiness, Budgeting, Planning, Customer Relations, Mergers, Risk, Software Products, Policy, Product Requirements, Administration, Waterfall, Web Project Management, Project Execution, Life Cycle Assessment, People Management, Quality Systems, Virtual Teams, Cost, Deployment, PMI, EMEA
Education
Northeastern University 1995 — 1996
Post Graduate State of the Art Program, Computer Software Engineering
Nacional'nij Tehnicnij Universytet 'Kharkivskij Polytehnicnij Institut' 1986 — 1988
Master of Science, Computer Science
Nacional'nij Tehnicnij Universytet 'Kharkivskij Polytehnicnij Institut' 1981 — 1986
Bachelor of science, Electronics Systems Engineering
Universidad Autónoma de Santo Domingo 1979 — 1981
Engineering Fundamentals, Electromechanical Engineering
Sandra Bennett Sandra Bennett's Maetrics, LLC Experience June 2013 - January 2014
Job Quality Assurance Engineer /Analyst at GlySens
Industry Medical Devices
Experience
GlySens August 2015 - Present
Astute Medical January 2014 - August 2015
Maetrics, LLC June 2013 - January 2014
Tandem Diabetes Care, Inc February 2012 - February 2013
Accumetrics November 2008 - September 2011
Tensys Medical, Inc March 2003 - November 2008
Nellcor Puritan Bennett Mallinckrodt (Now Covidien) January 1990 - November 2002
Skills
Lean Manufacturing, Process Validation, New Product..., Manufactuirng Line Setup, Process Improvement, ISO 13485, Continuous Improvement, Six Sigma, Product Development, Kaizen, Change Management, CAPA, Quality System, V&V, GMP, FDA, Validation, Medical Devices, MRP, ISO 9000, Quality Management..., Advanced Manufacturing, Technical Training, Team Leadership, Personal Development, Technical Documentation, Document Review, Configuration Management, ERP Software, Department Budgeting, Operations Management, Quality Control, Quality Auditing, KPI Reports, Communication Skills, Collaboration, Collaborative Problem..., Mentoring, ISO 14971, Quality Management, R&D, Iso 9000, Manufacturing, Cross-functional Team..., FMEA, ISO
Education
National University 1998 — 2000
Bachelor of Science
University of California, San Diego
Excel Partnership SAI Global
Logicon
GlySens August 2015 - Present
Astute Medical January 2014 - August 2015
Maetrics, LLC June 2013 - January 2014
Tandem Diabetes Care, Inc February 2012 - February 2013
Accumetrics November 2008 - September 2011
Tensys Medical, Inc March 2003 - November 2008
Nellcor Puritan Bennett Mallinckrodt (Now Covidien) January 1990 - November 2002
Skills
Lean Manufacturing, Process Validation, New Product..., Manufactuirng Line Setup, Process Improvement, ISO 13485, Continuous Improvement, Six Sigma, Product Development, Kaizen, Change Management, CAPA, Quality System, V&V, GMP, FDA, Validation, Medical Devices, MRP, ISO 9000, Quality Management..., Advanced Manufacturing, Technical Training, Team Leadership, Personal Development, Technical Documentation, Document Review, Configuration Management, ERP Software, Department Budgeting, Operations Management, Quality Control, Quality Auditing, KPI Reports, Communication Skills, Collaboration, Collaborative Problem..., Mentoring, ISO 14971, Quality Management, R&D, Iso 9000, Manufacturing, Cross-functional Team..., FMEA, ISO
Education
National University 1998 — 2000
Bachelor of Science
University of California, San Diego
Excel Partnership SAI Global
Logicon
Leslie Burris Leslie Burris's Maetrics, LLC Experience April 2013 - August 2013
Job Quality and Compliance Consultant
Industry Management Consulting
Experience
Quality and Compliance Consultant August 2013 - Present
Maetrics, LLC April 2013 - August 2013
MDA June 2011 - March 2013
Rath Inc. March 2009 - May 2011
Consolidated Container Company March 2008 - March 2009
Terumo Cardiovascular Systems June 2006 - March 2008
Terumo September 2000 - June 2006
Skills
Quality Assurance, Quality Management, Quality System, ISO, Quality Auditing, Validation, ISO 13485, Root Cause Analysis, Iso 9000, CAPA, 21 CFR Part 11, FDA, ISO 9000, Medical Devices, Manufacturing, Lean Manufacturing, Quality Control, Management, Process Improvement, GMP, Continuous Improvement
Education
Cecil College 2006 — 2008
Associate of Science (AS), Business Leadership & Management
Quality and Compliance Consultant August 2013 - Present
Maetrics, LLC April 2013 - August 2013
MDA June 2011 - March 2013
Rath Inc. March 2009 - May 2011
Consolidated Container Company March 2008 - March 2009
Terumo Cardiovascular Systems June 2006 - March 2008
Terumo September 2000 - June 2006
Skills
Quality Assurance, Quality Management, Quality System, ISO, Quality Auditing, Validation, ISO 13485, Root Cause Analysis, Iso 9000, CAPA, 21 CFR Part 11, FDA, ISO 9000, Medical Devices, Manufacturing, Lean Manufacturing, Quality Control, Management, Process Improvement, GMP, Continuous Improvement
Education
Cecil College 2006 — 2008
Associate of Science (AS), Business Leadership & Management
Betty Watson Betty Watson's Maetrics, LLC Experience March 2010 - November 2012
Job Radiologic Technologist at U.S. Department of Veterans Affairs
Industry Medical Devices
Experience
U.S. Department of Veterans Affairs August 2013 - Present
Independent Contractor 2012 - Present
Currently Unemployed April 1979 - Present
Depuyes-Synthes August 2012 - November 2012
Maetrics, LLC March 2010 - November 2012
Stryker March 2012 - June 2012
Philips Healthcare 2010 - 2012
Philips Healthcare September 2010 - February 2011
Skills
Healthcare Management, EHR, Epic Systems, Computed Tomography, HIPAA, Radiology, Healthcare, Hospitals, Digital Imaging, Medical Devices, Healthcare Information...
Education
University of Phoenix 2013 — 2015
Bachelor's Degree, Health/Health Care Administration/Management
Cuyahoga Community College 1979 — 2001
Associates, applied medical science
Sanford-Brown College-Cleveland 1998 — 2000
certificate, Ultrasound technology
U.S. Department of Veterans Affairs August 2013 - Present
Independent Contractor 2012 - Present
Currently Unemployed April 1979 - Present
Depuyes-Synthes August 2012 - November 2012
Maetrics, LLC March 2010 - November 2012
Stryker March 2012 - June 2012
Philips Healthcare 2010 - 2012
Philips Healthcare September 2010 - February 2011
Skills
Healthcare Management, EHR, Epic Systems, Computed Tomography, HIPAA, Radiology, Healthcare, Hospitals, Digital Imaging, Medical Devices, Healthcare Information...
Education
University of Phoenix 2013 — 2015
Bachelor's Degree, Health/Health Care Administration/Management
Cuyahoga Community College 1979 — 2001
Associates, applied medical science
Sanford-Brown College-Cleveland 1998 — 2000
certificate, Ultrasound technology
Tamala Wattree Tamala Wattree's Maetrics, LLC Experience May 2013 - July 2014
Job Compliance Specialist at Masimo
Industry Medical Devices
Experience
Masimo December 2014 - June 2015
Regulatory and Quality Solutions LLC (R&Q) September 2014 - November 2014
Maetrics LLC May 2013 - July 2014
Allergan November 2011 - February 2013
Hub International March 2011 - November 2011
Santa Barbara Graduate Institute November 2009 - February 2010
CRN Digital Talk Radio November 2008 - June 2009
Skills
Time Management, Marketing, Interviews, Public Relations, Management, Team Building, Customer Service, Customer Satisfaction, Editing, Policy, Proposal Writing, FDA, SAP, Medical Devices, Training, Outlook
Education
California State University-Northridge 2004 — 2007
Master of Arts (M.A.), Mass Communication/Media Studies, 3.6
University of California, Riverside 1999 — 2003
Bachelor of Arts (B.A.), Theater Arts, 3.4
Masimo December 2014 - June 2015
Regulatory and Quality Solutions LLC (R&Q) September 2014 - November 2014
Maetrics LLC May 2013 - July 2014
Allergan November 2011 - February 2013
Hub International March 2011 - November 2011
Santa Barbara Graduate Institute November 2009 - February 2010
CRN Digital Talk Radio November 2008 - June 2009
Skills
Time Management, Marketing, Interviews, Public Relations, Management, Team Building, Customer Service, Customer Satisfaction, Editing, Policy, Proposal Writing, FDA, SAP, Medical Devices, Training, Outlook
Education
California State University-Northridge 2004 — 2007
Master of Arts (M.A.), Mass Communication/Media Studies, 3.6
University of California, Riverside 1999 — 2003
Bachelor of Arts (B.A.), Theater Arts, 3.4
Faye Ryan's Maetrics, LLC Experience May 2013 - December 2014
Job Recruiter at ProfyleTracker
Industry Human Resources
Experience
Profyle Tracker April 2015 - Present
New Horizons Computer Learning Center - Indianapolis IN December 2014 - April 2015
Maetrics, LLC May 2013 - December 2014
ITT Technical Institute January 2013 - April 2013
ITT Technical Institute June 2011 - April 2013
ITT Technical Institute June 2012 - December 2012
ITT Technical Institute January 2012 - June 2012
ITT Technical Institute June 2011 - December 2011
Carmel Clay Schools August 2010 - May 2011
Carmel Clay Schools January 2010 - May 2010
Skills
Training, Recruiting, Customer Service, Leadership, Management, Interviews, Public Relations, Teaching, Sales, Microsoft Office, Public Speaking, Admissions, PowerPoint, Career Counseling, Marketing, Social Media, Time Management, Facebook, Microsoft Word, Event Planning, Higher Education, Coaching, Leadership Development, Interviewing Skills
Education
Ball State University 2005 — 2009
BA, Elementary Education
Profyle Tracker April 2015 - Present
New Horizons Computer Learning Center - Indianapolis IN December 2014 - April 2015
Maetrics, LLC May 2013 - December 2014
ITT Technical Institute January 2013 - April 2013
ITT Technical Institute June 2011 - April 2013
ITT Technical Institute June 2012 - December 2012
ITT Technical Institute January 2012 - June 2012
ITT Technical Institute June 2011 - December 2011
Carmel Clay Schools August 2010 - May 2011
Carmel Clay Schools January 2010 - May 2010
Skills
Training, Recruiting, Customer Service, Leadership, Management, Interviews, Public Relations, Teaching, Sales, Microsoft Office, Public Speaking, Admissions, PowerPoint, Career Counseling, Marketing, Social Media, Time Management, Facebook, Microsoft Word, Event Planning, Higher Education, Coaching, Leadership Development, Interviewing Skills
Education
Ball State University 2005 — 2009
BA, Elementary Education
Peter Varney Peter Varney's Maetrics, LLC Experience July 2013 - April 2014
Job Mechanical Spear System Administrator at Amtrak
Industry Transportation/Trucking/Railroad
Experience
Amtrak April 2014 - Present
Maetrics, LLC July 2013 - April 2014
New Chapter, Inc. January 2011 - May 2012
Janos Technology October 2009 - December 2010
Ruhmaus, LLC April 2007 - May 2010
True North Networks June 2006 - April 2007
Skills
Document Management, Integration, Operating Systems, Servers, Testing, Software Development, Troubleshooting, System Administration, Windows Server, Windows, Databases, Help Desk Support, Active Directory, Information Technology, Windows 7, Process Improvement, ERP, Software Documentation, Shell Scripting, Technical Support, Visual Basic, Microsoft Office, Disaster Recovery, SQL, Hallway Testing, CMS, Drupal, .NET, C#, Analysis, Networking, Microsoft SQL Server, Security, PHP, Quality Assurance, Hardware
Education
Keene State College 2006 — 2010
BS Applied Computer Science, Computer Science
Amtrak April 2014 - Present
Maetrics, LLC July 2013 - April 2014
New Chapter, Inc. January 2011 - May 2012
Janos Technology October 2009 - December 2010
Ruhmaus, LLC April 2007 - May 2010
True North Networks June 2006 - April 2007
Skills
Document Management, Integration, Operating Systems, Servers, Testing, Software Development, Troubleshooting, System Administration, Windows Server, Windows, Databases, Help Desk Support, Active Directory, Information Technology, Windows 7, Process Improvement, ERP, Software Documentation, Shell Scripting, Technical Support, Visual Basic, Microsoft Office, Disaster Recovery, SQL, Hallway Testing, CMS, Drupal, .NET, C#, Analysis, Networking, Microsoft SQL Server, Security, PHP, Quality Assurance, Hardware
Education
Keene State College 2006 — 2010
BS Applied Computer Science, Computer Science
Jean Lundquist Jean Lundquist's Maetrics, LLC Experience 2013 - 2013
Job Sr. Technical Writer
Industry Writing and Editing
Experience
Neozene, Inc. 2015 - 2015
Penguin Computing June 2014 - December 2014
KLA-Tencor May 2014 - June 2014
Stryker February 2013 - April 2014
IZON Media, LLC May 2012 - January 2013
Maetrics, LLC 2013 - 2013
Hewlett-Packard February 2011 - April 2012
Skills
Technical Writing, FrameMaker, Technical Communication, RoboHelp, Technical Documentation, Online Help, Manuals, SnagIt, Content Management, Software Documentation, Visio, Adobe Acrobat, Captivate, Content Development, SharePoint, Technical Training, Document Management, DITA, Information Architecture, Project Management, Agile Methodologies, XML, Documentation
Education
Claremont Graduate University 1988 — 1991
Master of Science (MS), Computer and Information Sciences, General
California State Polytechnic University-Pomona 1982 — 1985
Bachelor of Science (BS), Computer/Information Technology Administration and Management
Neozene, Inc. 2015 - 2015
Penguin Computing June 2014 - December 2014
KLA-Tencor May 2014 - June 2014
Stryker February 2013 - April 2014
IZON Media, LLC May 2012 - January 2013
Maetrics, LLC 2013 - 2013
Hewlett-Packard February 2011 - April 2012
Skills
Technical Writing, FrameMaker, Technical Communication, RoboHelp, Technical Documentation, Online Help, Manuals, SnagIt, Content Management, Software Documentation, Visio, Adobe Acrobat, Captivate, Content Development, SharePoint, Technical Training, Document Management, DITA, Information Architecture, Project Management, Agile Methodologies, XML, Documentation
Education
Claremont Graduate University 1988 — 1991
Master of Science (MS), Computer and Information Sciences, General
California State Polytechnic University-Pomona 1982 — 1985
Bachelor of Science (BS), Computer/Information Technology Administration and Management
Bhavana Kurian Bhavana Kurian's Maetrics, LLC Experience April 2013 - Present
Job Change Management Specialist at Hospira
Industry Pharmaceuticals
Experience
Hospira May 2015 - Present
Maetrics, LLC April 2013 - Present
Baxter Healthcare May 2011 - March 2013
Rush University Medical Center May 2009 - August 2009
Skills
Cell Culture, FDA GMP, 21 CFR 820, 21 CFR 803, Biotechnology, CAPA, Product Development, Research, R&D, Medical Devices, Compliance, Regulatory Submissions, Regulatory Affairs, MDRs, Adverse Event Reporting, GDP, Pharmaceutical Industry, Complaint Investigations, Product Complaints, Document Review, SOP, FDA, Quality System, GMP, Quality Assurance, 21 CFR
Education
University of Illinois at Chicago 2008 — 2010
Bachelor of Science (B.S.), Bioengineering and Biomedical Engineering
Oakton Community College 2006 — 2008
Hospira May 2015 - Present
Maetrics, LLC April 2013 - Present
Baxter Healthcare May 2011 - March 2013
Rush University Medical Center May 2009 - August 2009
Skills
Cell Culture, FDA GMP, 21 CFR 820, 21 CFR 803, Biotechnology, CAPA, Product Development, Research, R&D, Medical Devices, Compliance, Regulatory Submissions, Regulatory Affairs, MDRs, Adverse Event Reporting, GDP, Pharmaceutical Industry, Complaint Investigations, Product Complaints, Document Review, SOP, FDA, Quality System, GMP, Quality Assurance, 21 CFR
Education
University of Illinois at Chicago 2008 — 2010
Bachelor of Science (B.S.), Bioengineering and Biomedical Engineering
Oakton Community College 2006 — 2008
Julia Raye Julia Raye's Maetrics, LLC Experience January 2013 - March 2013
Job Principal Owner at Raye Regulatory Auditors
Industry Medical Devices
Experience
Raye Regulatory Auditors June 2014 - Present
Kelly Scientific Resources December 2013 - March 2014
Oxford International August 2013 - November 2013
Maetrics, LLC January 2013 - March 2013
Oxford International February 2012 - November 2012
Solstas Lab Partners July 2011 - October 2011
Hemarus June 2010 - July 2010
Vistakon March 2010 - May 2010
Covidien September 2007 - January 2009
Battelle-CDC August 2003 - June 2006
Skills
FDA, Medical Devices, ISO 13485, Regulatory Affairs, SOP, Quality Systems, CAPA, Validation, Quality Assurance, 21 CFR Part 11, Quality System, Sop, Pharmaceutical Industry, GMP, Software Documentation, Change Control, Quality Auditing, Quality Management, R&D, Cross-functional Team..., Laboratory, Root Cause Analysis, ISO, Regulatory Requirements, Regulatory Submissions, V&V, Process Improvement, Aseptic Processing, Quality Control, Biotechnology, LIMS, Design Control, GLP, GxP, Computer System..., Technology Transfer, Lifesciences, Biopharmaceuticals, Cleaning Validation, FMEA, Analytical Chemistry, Chromatography, Process Simulation, HPLC, Clinical Trials, Vaccines, GCP, Pharmaceutics, Six Sigma, Gas Chromatography
Education
Northeastern University - Graduate School of Business Administration 2011 — 2015
Master's Degree, Regulatory Affairs in Drugs, Biologics and Medical Devices
Paine College 1983 — 1989
Bachelor of Science, Chemistry
Raye Regulatory Auditors June 2014 - Present
Kelly Scientific Resources December 2013 - March 2014
Oxford International August 2013 - November 2013
Maetrics, LLC January 2013 - March 2013
Oxford International February 2012 - November 2012
Solstas Lab Partners July 2011 - October 2011
Hemarus June 2010 - July 2010
Vistakon March 2010 - May 2010
Covidien September 2007 - January 2009
Battelle-CDC August 2003 - June 2006
Skills
FDA, Medical Devices, ISO 13485, Regulatory Affairs, SOP, Quality Systems, CAPA, Validation, Quality Assurance, 21 CFR Part 11, Quality System, Sop, Pharmaceutical Industry, GMP, Software Documentation, Change Control, Quality Auditing, Quality Management, R&D, Cross-functional Team..., Laboratory, Root Cause Analysis, ISO, Regulatory Requirements, Regulatory Submissions, V&V, Process Improvement, Aseptic Processing, Quality Control, Biotechnology, LIMS, Design Control, GLP, GxP, Computer System..., Technology Transfer, Lifesciences, Biopharmaceuticals, Cleaning Validation, FMEA, Analytical Chemistry, Chromatography, Process Simulation, HPLC, Clinical Trials, Vaccines, GCP, Pharmaceutics, Six Sigma, Gas Chromatography
Education
Northeastern University - Graduate School of Business Administration 2011 — 2015
Master's Degree, Regulatory Affairs in Drugs, Biologics and Medical Devices
Paine College 1983 — 1989
Bachelor of Science, Chemistry
Paul Schnur Paul Schnur's Maetrics, LLC Experience October 2012 - July 2013
Job Sr Mechanical Engineer, TransEnterix
Industry Medical Devices
Experience
TransEnterix, Inc. July 2013 - Present
Maetrics, LLC October 2012 - July 2013
Covidien PLC October 2009 - May 2012
Power Medical Interventions, Inc October 2001 - October 2009
Agere Systems December 2000 - October 2001
Quad Systems Incorporated March 1998 - December 2000
Kulicke & Soffa Industries, Inc March 1988 - March 1998
Skills
Medical Devices, Design Control, Quality System, Product Launch, Product Design, Product Development, Cross-functional Team..., FDA, Product Management, Solidworks, Validation, Manufacturing, Continuous Improvement, Start-ups, Manufacturing..., Design for Manufacturing, CAPA, Engineering, Design of Experiments, Root Cause Analysis, R&D, Biomedical Engineering, FMEA, GD, Testing, V
Education
Bucks County Community College
Bucks County Community College
Mechanical Engineering
Montgomery County Community College
PTS Learning Systems
Pennco Technical Institute
Associate, Electronic Engineering
TransEnterix, Inc. July 2013 - Present
Maetrics, LLC October 2012 - July 2013
Covidien PLC October 2009 - May 2012
Power Medical Interventions, Inc October 2001 - October 2009
Agere Systems December 2000 - October 2001
Quad Systems Incorporated March 1998 - December 2000
Kulicke & Soffa Industries, Inc March 1988 - March 1998
Skills
Medical Devices, Design Control, Quality System, Product Launch, Product Design, Product Development, Cross-functional Team..., FDA, Product Management, Solidworks, Validation, Manufacturing, Continuous Improvement, Start-ups, Manufacturing..., Design for Manufacturing, CAPA, Engineering, Design of Experiments, Root Cause Analysis, R&D, Biomedical Engineering, FMEA, GD, Testing, V
Education
Bucks County Community College
Bucks County Community College
Mechanical Engineering
Montgomery County Community College
PTS Learning Systems
Pennco Technical Institute
Associate, Electronic Engineering
Craig Adelman Craig Adelman's Maetrics, LLC Experience February 2013 - July 2014
Job Senior Product Surveillance Specialist at The Fountain Group
Industry Medical Devices
Experience
The Fountain Group June 2015 - Present
Validant July 2014 - February 2015
Maetrics, LLC February 2013 - July 2014
Hospira February 2012 - February 2013
Auxilium Pharmaceuticals February 2010 - June 2011
PPD January 2009 - February 2010
Merck June 2007 - December 2009
Thomas Jefferson University December 2006 - June 2007
Medical Diagnostic Laboratory April 2006 - November 2006
Skills
cGMP, HPLC, Chromatography, Protein Chemistry, Medical Devices, Quality System..., 21 CFR Part 11, Root Cause Analysis, CAPA, Organizational..., LIMS, GMP, FDA, Biotechnology, Sop, ELISA, Quality System, Cell, Laboratory, Quality Control, UV/Vis, PCR
Education
Ashford University 2010 — 2012
M.A., Organizational Management
Thomas Jefferson University 2005 — 2007
B.S., Biotechnology
The Fountain Group June 2015 - Present
Validant July 2014 - February 2015
Maetrics, LLC February 2013 - July 2014
Hospira February 2012 - February 2013
Auxilium Pharmaceuticals February 2010 - June 2011
PPD January 2009 - February 2010
Merck June 2007 - December 2009
Thomas Jefferson University December 2006 - June 2007
Medical Diagnostic Laboratory April 2006 - November 2006
Skills
cGMP, HPLC, Chromatography, Protein Chemistry, Medical Devices, Quality System..., 21 CFR Part 11, Root Cause Analysis, CAPA, Organizational..., LIMS, GMP, FDA, Biotechnology, Sop, ELISA, Quality System, Cell, Laboratory, Quality Control, UV/Vis, PCR
Education
Ashford University 2010 — 2012
M.A., Organizational Management
Thomas Jefferson University 2005 — 2007
B.S., Biotechnology
Jason Brock's Maetrics, LLC Experience September 2013 - Present
Job Senior Corporate Recruiter at Maetrics, LLC
Industry Human Resources
Experience
Maetrics, LLC September 2013 - Present
Butler America February 2011 - September 2013
RN & Allied Specialties, Inc. September 2010 - February 2011
Specialty Staff, Inc July 2009 - August 2010
DSS Consulting August 2006 - May 2009
Tricad Engineering October 2004 - August 2006
Century Personnel July 2003 - October 2004
Independent Contractor October 1996 - July 2003
Century Personnel February 1993 - October 1996
Skills
Applicant Tracking..., Microsoft Office, Microsoft Excel, Microsoft Word, Contract Recruitment, Contract Negotiation, Direct Hires, E-Verify, Background Checks, Human Resources, Public Speaking, Coaching, Public Relations, Cold Calling Experience, Sales, Twitter, Screening Resumes, Communication, Benefits Negotiation, Cold Calling, Internet Recruiting, Technical Recruiting, Interviews, Sourcing, Recruiting, Temporary Placement, Staff Augmentation, Onboarding, Screening, Job Fairs, Talent Acquisition, College Recruiting, Permanent Placement, Executive Search, Staffing Services, Temporary Staffing, Employee Benefits, IT Recruitment, Networking, Management, Employee Relations, Resume Writing, New Hire Orientations, Taleo, Boolean Searching, Industrial Sector, Workforce Planning, Employer Branding, Recruitment Advertising, HRIS
Education
Ball State University 1987 — 1989
NONE, Telecommunications, Public Speaking
Frankfort Sr. High School 1983 — 1987
Diploma, General Studies
Maetrics, LLC September 2013 - Present
Butler America February 2011 - September 2013
RN & Allied Specialties, Inc. September 2010 - February 2011
Specialty Staff, Inc July 2009 - August 2010
DSS Consulting August 2006 - May 2009
Tricad Engineering October 2004 - August 2006
Century Personnel July 2003 - October 2004
Independent Contractor October 1996 - July 2003
Century Personnel February 1993 - October 1996
Skills
Applicant Tracking..., Microsoft Office, Microsoft Excel, Microsoft Word, Contract Recruitment, Contract Negotiation, Direct Hires, E-Verify, Background Checks, Human Resources, Public Speaking, Coaching, Public Relations, Cold Calling Experience, Sales, Twitter, Screening Resumes, Communication, Benefits Negotiation, Cold Calling, Internet Recruiting, Technical Recruiting, Interviews, Sourcing, Recruiting, Temporary Placement, Staff Augmentation, Onboarding, Screening, Job Fairs, Talent Acquisition, College Recruiting, Permanent Placement, Executive Search, Staffing Services, Temporary Staffing, Employee Benefits, IT Recruitment, Networking, Management, Employee Relations, Resume Writing, New Hire Orientations, Taleo, Boolean Searching, Industrial Sector, Workforce Planning, Employer Branding, Recruitment Advertising, HRIS
Education
Ball State University 1987 — 1989
NONE, Telecommunications, Public Speaking
Frankfort Sr. High School 1983 — 1987
Diploma, General Studies
Brian Henderson Brian Henderson's Maetrics, LLC Experience January 2012 - June 2013
Job Corporate Recruiter
Industry Biotechnology
Experience
Barry-Wehmiller Design Group February 2014 - Present
Maetrics, LLC January 2012 - June 2013
Smart IT Staffing August 2008 - December 2011
Kelly Scientific Resources June 2006 - August 2008
National Institutes of Health September 2002 - May 2005
Charles River Laboratories July 2001 - August 2002
Skills
Recruiting, Temporary Placement, Staffing Services, Business Development, Internet Recruiting, College Recruiting, SDLC, Technical Recruiting, Medical Devices, Biotechnology, Applicant Tracking..., Contract Recruitment, Pharmaceutical Industry, Engineering, Lifesciences, Screening, GMP, Protein Purification, Western Blotting, Golf, Sourcing, Fermentation, ELISA, Interviews, Chemistry, Biology, Talent Acquisition, GLP, Quality Assurance, Sop, Validation, FDA, Regulatory Affairs, Quality System, Resume Writing, Human Resources, Screening Resumes, GCP, Temporary Staffing, IT Recruitment, Interviewing, Golf Club..., Permanent Placement, Staff Augmentation, Onboarding, Executive Search, Hiring
Education
Hanover College 1997 — 2001
BA, Biology
Barry-Wehmiller Design Group February 2014 - Present
Maetrics, LLC January 2012 - June 2013
Smart IT Staffing August 2008 - December 2011
Kelly Scientific Resources June 2006 - August 2008
National Institutes of Health September 2002 - May 2005
Charles River Laboratories July 2001 - August 2002
Skills
Recruiting, Temporary Placement, Staffing Services, Business Development, Internet Recruiting, College Recruiting, SDLC, Technical Recruiting, Medical Devices, Biotechnology, Applicant Tracking..., Contract Recruitment, Pharmaceutical Industry, Engineering, Lifesciences, Screening, GMP, Protein Purification, Western Blotting, Golf, Sourcing, Fermentation, ELISA, Interviews, Chemistry, Biology, Talent Acquisition, GLP, Quality Assurance, Sop, Validation, FDA, Regulatory Affairs, Quality System, Resume Writing, Human Resources, Screening Resumes, GCP, Temporary Staffing, IT Recruitment, Interviewing, Golf Club..., Permanent Placement, Staff Augmentation, Onboarding, Executive Search, Hiring
Education
Hanover College 1997 — 2001
BA, Biology
Loretta Clemmans Loretta Clemmans's Maetrics, LLC Experience May 2013 - February 2015
Job Records Manager thru Oxford International
Industry Medical Devices
Experience
Oxford International February 2015 - Present
Maetrics, LLC May 2013 - February 2015
GE Capital Americas December 2011 - May 2013
GE Healthcare May 2006 - December 2011
GE Healthcare May 2006 - December 2011
Danaher/Kavo/Gendex Dental Systems December 2004 - May 2006
GE Healthcare (formerly Amersham Health) June 2001 - December 2004
Skills
Software Documentation, Quality System, Quality Assurance, FDA, Medical Devices, GMP, Validation, ISO 13485, Cross-functional Team..., Quality Control, Change Control, CAPA, 21 CFR Part 11, Product Development, ISO, Design Control, Training, V&V, ISO 14971, Regulatory Affairs, Process Improvement, Manufacturing, Management, SOP, Business Process..., Program Management, Quality Management, Customer Service, Contract Negotiation, Data Analysis, Real Estate, Healthcare, Continuous Improvement, Team Leadership, Microsoft Office, Auditing, Records Management
Education
Elgin Community College 2000 — 2002
Certification, Herbalism
Foreman High School
Oxford International February 2015 - Present
Maetrics, LLC May 2013 - February 2015
GE Capital Americas December 2011 - May 2013
GE Healthcare May 2006 - December 2011
GE Healthcare May 2006 - December 2011
Danaher/Kavo/Gendex Dental Systems December 2004 - May 2006
GE Healthcare (formerly Amersham Health) June 2001 - December 2004
Skills
Software Documentation, Quality System, Quality Assurance, FDA, Medical Devices, GMP, Validation, ISO 13485, Cross-functional Team..., Quality Control, Change Control, CAPA, 21 CFR Part 11, Product Development, ISO, Design Control, Training, V&V, ISO 14971, Regulatory Affairs, Process Improvement, Manufacturing, Management, SOP, Business Process..., Program Management, Quality Management, Customer Service, Contract Negotiation, Data Analysis, Real Estate, Healthcare, Continuous Improvement, Team Leadership, Microsoft Office, Auditing, Records Management
Education
Elgin Community College 2000 — 2002
Certification, Herbalism
Foreman High School
Debra Stull Debra Stull's Maetrics, LLC Experience May 2014 - December 2014
Job QA Compliance Analyist | Open to new opportunities
Industry Medical Devices
Experience
Aerotek August 2015 - Present
Maetrics, LLC May 2014 - December 2014
Philips Healthcare May 2012 - April 2014
Kent State University June 2004 - May 2012
Summa Barberton Citizens Hospital February 2000 - May 2012
Skills
Medical Devices, ISO 13485, FDA, Medical Imaging, Radiology, Quality System, Cross-functional Team..., Process Improvement, Training, Nuclear Medicine, Complaint Management, Complaint Investigations, Compliance Remediation, MedWatch 3500A MDR, CAPA, Customer Service, Healthcare, Clinical Research
Education
Kent State University 2005 — 2011
BGS, General with minor in Conflict Management, GPA 3.79
The Ohio State University Medical Center 1995 — 1996
Certified Nuclear Medicine Technologist, Nuclear Medicine Technology
Aerotek August 2015 - Present
Maetrics, LLC May 2014 - December 2014
Philips Healthcare May 2012 - April 2014
Kent State University June 2004 - May 2012
Summa Barberton Citizens Hospital February 2000 - May 2012
Skills
Medical Devices, ISO 13485, FDA, Medical Imaging, Radiology, Quality System, Cross-functional Team..., Process Improvement, Training, Nuclear Medicine, Complaint Management, Complaint Investigations, Compliance Remediation, MedWatch 3500A MDR, CAPA, Customer Service, Healthcare, Clinical Research
Education
Kent State University 2005 — 2011
BGS, General with minor in Conflict Management, GPA 3.79
The Ohio State University Medical Center 1995 — 1996
Certified Nuclear Medicine Technologist, Nuclear Medicine Technology
Jill Melanson, MBA Jill Melanson, MBA's Maetrics, LLC Experience April 2013 - November 2013
Job Project Administrator at Designeers Midwest
Industry Oil & Energy
Experience
Designeers Midwest July 2015 - Present
Adecco March 2015 - September 2015
CDI Corporation March 2014 - August 2014
Validant December 2013 - February 2014
Kelly Services October 2014 - 2014
Maetrics, LLC April 2013 - November 2013
Adecco Staffing, USA January 2013 - April 2013
Casual Male Retail Group October 2012 - January 2013
Siemens Building Technologies May 2012 - November 2012
Computershare June 2012 - August 2012
Skills
Quality Assurance, Training, Access, Customer Satisfaction, Customer Service, Call Centers, Software Documentation, Technical Support, SAP, Medical Devices, Microsoft Office, Microsoft Excel, Process Improvement, Lotus Notes, FDA, Call Center, Microsoft Word, Process Scheduler, Oracle, Sales, Outlook, Data Entry, PowerPoint, Teamwork, Management, Retail, Troubleshooting, Leadership, Cross-functional Team..., Data Analysis, Time Management, Customer Support, Research, Social Networking, Customer Experience, Cold Calling, CATSWeb, Account Reconciliation, Compliance, Pilgrim, 21CFR820.198, Analysis, Healthcare, Agile, Inventory Management, MDRs, Medwatch 3500a, eSubmitter, Team Building
Education
University of Phoenix 2006 — 2009
MBA, Business Administration
Framingham State University 1997 — 1999
BA Degree, Sociology
Middlesex Community College 1996 — 1997
A.S., Liberal Studies
University of Massachusetts, Amherst 1994 — 1995
N/A, Undecided
Billerica Memorial High School 1990 — 1994
HS Diploma, College Prep
Designeers Midwest July 2015 - Present
Adecco March 2015 - September 2015
CDI Corporation March 2014 - August 2014
Validant December 2013 - February 2014
Kelly Services October 2014 - 2014
Maetrics, LLC April 2013 - November 2013
Adecco Staffing, USA January 2013 - April 2013
Casual Male Retail Group October 2012 - January 2013
Siemens Building Technologies May 2012 - November 2012
Computershare June 2012 - August 2012
Skills
Quality Assurance, Training, Access, Customer Satisfaction, Customer Service, Call Centers, Software Documentation, Technical Support, SAP, Medical Devices, Microsoft Office, Microsoft Excel, Process Improvement, Lotus Notes, FDA, Call Center, Microsoft Word, Process Scheduler, Oracle, Sales, Outlook, Data Entry, PowerPoint, Teamwork, Management, Retail, Troubleshooting, Leadership, Cross-functional Team..., Data Analysis, Time Management, Customer Support, Research, Social Networking, Customer Experience, Cold Calling, CATSWeb, Account Reconciliation, Compliance, Pilgrim, 21CFR820.198, Analysis, Healthcare, Agile, Inventory Management, MDRs, Medwatch 3500a, eSubmitter, Team Building
Education
University of Phoenix 2006 — 2009
MBA, Business Administration
Framingham State University 1997 — 1999
BA Degree, Sociology
Middlesex Community College 1996 — 1997
A.S., Liberal Studies
University of Massachusetts, Amherst 1994 — 1995
N/A, Undecided
Billerica Memorial High School 1990 — 1994
HS Diploma, College Prep
Robert Zagmot's Maetrics, LLC Experience April 2013 - May 2013
Job Medical Device and Pharmaceutical Quality Consultant
Industry Medical Devices
Experience
Validant June 2013 - Present
Stevens Institute of Technology January 2014 - Present
Maetrics, LLC April 2013 - May 2013
CR Bard July 2009 - February 2012
Roche January 2004 - June 2009
Zagmot Consulting January 2003 - January 2004
Anadigics January 2001 - January 2003
Price Pfister Faucets of Black & Decker (currently Pfister Faucets) January 2000 - January 2001
Seagate Technology August 1998 - January 2000
Rodel, Inc. (later bought by Rohm and Haas) August 1995 - August 1998
Skills
FDA, Quality Assurance, CAPA, Continuous Improvement, Quality System, Validation, ISO 13485, GMP, Design Control, Medical Devices, Quality Auditing, Quality Management, Six Sigma, 21 CFR Part 11, Root Cause Analysis, Quality Control, Change Control, Computer System..., V&V, Lean Manufacturing, Cross-functional Team..., Black Belt, Manufacturing, Design of Experiments, FMEA, SPC, Operational Excellence, DMAIC, Process Simulation, Sop, Minitab, ISO, Testing, Product Development, Value Stream Mapping, Green Belt, Kaizen, Statistical Data...
Education
Regis University 2002 — 2004
MBA, Business Administration and Management, General
University of Delaware 1991 — 1995
BS, Mechnical Engineering
Validant June 2013 - Present
Stevens Institute of Technology January 2014 - Present
Maetrics, LLC April 2013 - May 2013
CR Bard July 2009 - February 2012
Roche January 2004 - June 2009
Zagmot Consulting January 2003 - January 2004
Anadigics January 2001 - January 2003
Price Pfister Faucets of Black & Decker (currently Pfister Faucets) January 2000 - January 2001
Seagate Technology August 1998 - January 2000
Rodel, Inc. (later bought by Rohm and Haas) August 1995 - August 1998
Skills
FDA, Quality Assurance, CAPA, Continuous Improvement, Quality System, Validation, ISO 13485, GMP, Design Control, Medical Devices, Quality Auditing, Quality Management, Six Sigma, 21 CFR Part 11, Root Cause Analysis, Quality Control, Change Control, Computer System..., V&V, Lean Manufacturing, Cross-functional Team..., Black Belt, Manufacturing, Design of Experiments, FMEA, SPC, Operational Excellence, DMAIC, Process Simulation, Sop, Minitab, ISO, Testing, Product Development, Value Stream Mapping, Green Belt, Kaizen, Statistical Data...
Education
Regis University 2002 — 2004
MBA, Business Administration and Management, General
University of Delaware 1991 — 1995
BS, Mechnical Engineering
David BenJoseph's Maetrics, LLC Experience December 2013 - Present
Job Compliance and Quality Consultant at Maetrics, LLC
Industry Medical Practice
Experience
Maetrics, LLC December 2013 - Present
inSync Staffing March 2012 - February 2013
Fifth City Hospital November 2007 - November 2011
Fifth City Hospital, Sofia April 2007 - November 2007
Medical University - Sofia October 1988 - January 2007
St. Ivan Rilski Univ. Hosp. May 2004 - December 2006
St. Ivan Rilski Univ. Hosp. October 2000 - May 2004
Monitoring Force March 2002 - February 2003
S&P Pharmatest Management November 1994 - October 2000
Gastroenterology Clinic October 1988 - October 2000
Skills
English, Language Skills, Russian, Clinical Chemistry, Hematology, Clinical Research, Healthcare, Medical Devices, Clinical Trials, Quality Assurance, Clinical, Life Sciences, Regulatory Affairs, Research, Oncology, Immunology, Hospitals, Laboratory Medicine, CRO, GCP, Pharmaceuticals, Biotechnology, Clinical Data Management, Molecular Biology, Diagnostics, Infectious Diseases, FDA, Microbiology, PCR, Clinical Trial..., SOP, Clinical Development, GLP, Validation, Healthcare IT, Biochemistry, Cancer, GMP, Health, Compliance, ELISA, Documentation, Data Management, Supervisory Skills, Statistics, Medical Writing, LIMS, Data Analysis, Quality Management, Pharmacovigilance
Education
Medicinski universitet - Sofia 1979 — 1985
MD, Clinical Laboratory
125 Basic School "Dr. Ivan Pashov", Sofia 1966 — 1973
Maetrics, LLC December 2013 - Present
inSync Staffing March 2012 - February 2013
Fifth City Hospital November 2007 - November 2011
Fifth City Hospital, Sofia April 2007 - November 2007
Medical University - Sofia October 1988 - January 2007
St. Ivan Rilski Univ. Hosp. May 2004 - December 2006
St. Ivan Rilski Univ. Hosp. October 2000 - May 2004
Monitoring Force March 2002 - February 2003
S&P Pharmatest Management November 1994 - October 2000
Gastroenterology Clinic October 1988 - October 2000
Skills
English, Language Skills, Russian, Clinical Chemistry, Hematology, Clinical Research, Healthcare, Medical Devices, Clinical Trials, Quality Assurance, Clinical, Life Sciences, Regulatory Affairs, Research, Oncology, Immunology, Hospitals, Laboratory Medicine, CRO, GCP, Pharmaceuticals, Biotechnology, Clinical Data Management, Molecular Biology, Diagnostics, Infectious Diseases, FDA, Microbiology, PCR, Clinical Trial..., SOP, Clinical Development, GLP, Validation, Healthcare IT, Biochemistry, Cancer, GMP, Health, Compliance, ELISA, Documentation, Data Management, Supervisory Skills, Statistics, Medical Writing, LIMS, Data Analysis, Quality Management, Pharmacovigilance
Education
Medicinski universitet - Sofia 1979 — 1985
MD, Clinical Laboratory
125 Basic School "Dr. Ivan Pashov", Sofia 1966 — 1973
Susan Lewandowski's Maetrics, LLC Experience February 2013 - April 2014
Job Project Leader, Regulatory Affairs CMF at Depuy Synthes
Industry Medical Devices
Experience
Depuy Synthes April 2014 - Present
Maetrics, LLC February 2013 - April 2014
Endo Pharmaceuticals January 2011 - February 2013
Synthes November 2003 - December 2010
Cephalon, Inc. October 2001 - November 2003
Watson Pharmaceutical Inc. December 1999 - June 2001
Lannett Company Inc. July 1994 - January 1999
Mutual Pharmaceutical Company November 1992 - July 1994
Skills
Regulatory Affairs, Regulatory Submissions, Regulatory Requirements, Problem Solving, Team Management, Medical Devices, ISO 13485, Quality Assurance, FDA, V&V, Clinical Trials, Biotechnology, Clinical Development, CMC, Product Development, GCP, 21 CFR Part 11, Quality System, Software Documentation, Sop, GLP, CAPA, Pharmaceutical Industry, IND, GMP, Validation, Change Control, CRO, Computer System..., Orthopedic, Design Control, Technology Transfer, Protocol, Oncology, R&D, Pharmaceutics, eCTD, GxP, ISO 14971, Quality Auditing, Drug Development, Biopharmaceuticals, Clinical Research, Neurology, Biologics, CTMS, Pharmacovigilance, Therapeutic Areas, NDA, Lifesciences
Education
Temple University 1996 — 2001
MS, QA and Regulatory Affairs
Temple University 1988 — 1992
BS, Elementary Education
Depuy Synthes April 2014 - Present
Maetrics, LLC February 2013 - April 2014
Endo Pharmaceuticals January 2011 - February 2013
Synthes November 2003 - December 2010
Cephalon, Inc. October 2001 - November 2003
Watson Pharmaceutical Inc. December 1999 - June 2001
Lannett Company Inc. July 1994 - January 1999
Mutual Pharmaceutical Company November 1992 - July 1994
Skills
Regulatory Affairs, Regulatory Submissions, Regulatory Requirements, Problem Solving, Team Management, Medical Devices, ISO 13485, Quality Assurance, FDA, V&V, Clinical Trials, Biotechnology, Clinical Development, CMC, Product Development, GCP, 21 CFR Part 11, Quality System, Software Documentation, Sop, GLP, CAPA, Pharmaceutical Industry, IND, GMP, Validation, Change Control, CRO, Computer System..., Orthopedic, Design Control, Technology Transfer, Protocol, Oncology, R&D, Pharmaceutics, eCTD, GxP, ISO 14971, Quality Auditing, Drug Development, Biopharmaceuticals, Clinical Research, Neurology, Biologics, CTMS, Pharmacovigilance, Therapeutic Areas, NDA, Lifesciences
Education
Temple University 1996 — 2001
MS, QA and Regulatory Affairs
Temple University 1988 — 1992
BS, Elementary Education
Brian Chviruk, P.E.'s Maetrics, LLC Experience June 2006 - January 2007
Job Manager of Investigations, Production Technical Support at Shire Pharmaceuticals
Industry Pharmaceuticals
Experience
Shire Pharmaceuticals August 2015 - Present
Shire Pharmaceuticals February 2014 - Present
Shire Pharmaceuticals August 2012 - February 2014
Bristol-Myers Squibb March 2012 - August 2012
Bristol-Myers Squibb July 2009 - March 2012
Bristol-Myers Squibb January 2007 - July 2009
Maetrics LLC June 2006 - January 2007
Johnson Matthey Pharma Services / Pharm-Eco January 2003 - May 2006
Transform Pharmaceuticals June 2002 - September 2002
Skills
Process Automation, Validation, FDA, cGMP, Manufacturing Management, Design of Experiments, SharePoint, project management, Risk Assessment, Technical Writing, GMP, Project Management, Manufacturing..., Six Sigma, Quality System, Process Improvement, Sop, Engineering, Computer System..., CAPA, Quality Management, Change Control, GAMP, 21 CFR Part 11, Pharmaceutical Industry, Process Engineering, Trackwise, Commissioning, Cross-functional Team..., Cleaning Validation, V&V, Process Simulation, Biotechnology, Biopharmaceuticals, Process Optimization, Automation, Root Cause Analysis, Medical Devices, Quality Assurance, FDA GMP, MES, Chemical Engineering
Education
Worcester Polytechnic Institute 2009 — 2011
Masters, Bioscience Administration
Dartmouth College 2001 — 2003
M.E.M, Engineering Management
Bucknell University 1997 — 2001
B.S., Chemical Engineering
Auburn High School 1993 — 1997
Shire Pharmaceuticals August 2015 - Present
Shire Pharmaceuticals February 2014 - Present
Shire Pharmaceuticals August 2012 - February 2014
Bristol-Myers Squibb March 2012 - August 2012
Bristol-Myers Squibb July 2009 - March 2012
Bristol-Myers Squibb January 2007 - July 2009
Maetrics LLC June 2006 - January 2007
Johnson Matthey Pharma Services / Pharm-Eco January 2003 - May 2006
Transform Pharmaceuticals June 2002 - September 2002
Skills
Process Automation, Validation, FDA, cGMP, Manufacturing Management, Design of Experiments, SharePoint, project management, Risk Assessment, Technical Writing, GMP, Project Management, Manufacturing..., Six Sigma, Quality System, Process Improvement, Sop, Engineering, Computer System..., CAPA, Quality Management, Change Control, GAMP, 21 CFR Part 11, Pharmaceutical Industry, Process Engineering, Trackwise, Commissioning, Cross-functional Team..., Cleaning Validation, V&V, Process Simulation, Biotechnology, Biopharmaceuticals, Process Optimization, Automation, Root Cause Analysis, Medical Devices, Quality Assurance, FDA GMP, MES, Chemical Engineering
Education
Worcester Polytechnic Institute 2009 — 2011
Masters, Bioscience Administration
Dartmouth College 2001 — 2003
M.E.M, Engineering Management
Bucknell University 1997 — 2001
B.S., Chemical Engineering
Auburn High School 1993 — 1997
Marilee Fields's Maetrics, LLC Experience May 2013 - September 2013
Job Document Control Lead
Industry Biotechnology
Experience
Abiomed March 2015 - Present
Maquet Getinge Group 2013 - 2014
Maetrics, LLC May 2013 - September 2013
Genzyme November 2011 - March 2013
Genzyme April 2009 - November 2011
Genzyme May 1998 - April 2009
Skills
Quality Assurance, Software Documentation, GMP, FDA, Sop, Process Improvement, Document Management, Management, Training, Quality Control, Program Management, Manufacturing, CAPA, Lean Manufacturing, Auditing, Medical Devices, Change Control, SOP
Education
Nichols College 2002 — 2003
Bachelor of Business Administration (B.B.A.), Business Administration, Management and Operations
Abiomed March 2015 - Present
Maquet Getinge Group 2013 - 2014
Maetrics, LLC May 2013 - September 2013
Genzyme November 2011 - March 2013
Genzyme April 2009 - November 2011
Genzyme May 1998 - April 2009
Skills
Quality Assurance, Software Documentation, GMP, FDA, Sop, Process Improvement, Document Management, Management, Training, Quality Control, Program Management, Manufacturing, CAPA, Lean Manufacturing, Auditing, Medical Devices, Change Control, SOP
Education
Nichols College 2002 — 2003
Bachelor of Business Administration (B.B.A.), Business Administration, Management and Operations
Nii Jones-Quartey's Maetrics, LLC Experience October 2013 - January 2015
Job Validation and Process Engineering Consultant
Industry Pharmaceuticals
Experience
Maetrics, LLC October 2013 - January 2015
RCM Technologies April 2013 - July 2013
KAB Consulting Services March 2011 - April 2013
Otsuka Pharmaceutical Companies (U.S.) March 2008 - March 2011
Eli Lilly and Company 2003 - 2007
Shire Pharmaceuticals 1997 - 2003
Consulting Engineering Services November 1996 - December 1997
Alpharma 1993 - 1996
Skills
GMP, Medical Devices, Packaging, Process Engineering, Process Validation, V&V, Technology Transfer, Validation, R&D, Pharmaceutical Industry, FDA, Quality Control, Manufacturing, Quality System, CAPA, SOP, 21 CFR Part 11
Education
Texas A&M University
MS, Industrial Engineering Technology
City College of New York
BS, Electro-Mechanical Technology
Maetrics, LLC October 2013 - January 2015
RCM Technologies April 2013 - July 2013
KAB Consulting Services March 2011 - April 2013
Otsuka Pharmaceutical Companies (U.S.) March 2008 - March 2011
Eli Lilly and Company 2003 - 2007
Shire Pharmaceuticals 1997 - 2003
Consulting Engineering Services November 1996 - December 1997
Alpharma 1993 - 1996
Skills
GMP, Medical Devices, Packaging, Process Engineering, Process Validation, V&V, Technology Transfer, Validation, R&D, Pharmaceutical Industry, FDA, Quality Control, Manufacturing, Quality System, CAPA, SOP, 21 CFR Part 11
Education
Texas A&M University
MS, Industrial Engineering Technology
City College of New York
BS, Electro-Mechanical Technology
Travis Wiley's Maetrics, LLC Experience September 2011 - Present
Job CQT Consultant at Maetrics, LLC
Industry Biotechnology
Experience
Maetrics, LLC September 2011 - Present
Baxter March 2010 - September 2011
United BioSource Corporation July 2009 - March 2010
Amylin Pharmaceuticals 2008 - 2009
Genentech May 1998 - January 2008
Skills
FDA, Validation, Medical Devices, CAPA, 21 CFR Part 11, Pharmaceutical Industry, GMP, Quality Assurance, Sop, Biotechnology
Education
Central Michigan University 2012 — 2016
Doctorate, Health Administration
University of Phoenix 2008 — 2010
MBA, Healthcare Administration
San Jose State University 1993 — 1998
BA, Biological Science
Maetrics, LLC September 2011 - Present
Baxter March 2010 - September 2011
United BioSource Corporation July 2009 - March 2010
Amylin Pharmaceuticals 2008 - 2009
Genentech May 1998 - January 2008
Skills
FDA, Validation, Medical Devices, CAPA, 21 CFR Part 11, Pharmaceutical Industry, GMP, Quality Assurance, Sop, Biotechnology
Education
Central Michigan University 2012 — 2016
Doctorate, Health Administration
University of Phoenix 2008 — 2010
MBA, Healthcare Administration
San Jose State University 1993 — 1998
BA, Biological Science
Tricia Udovich's Maetrics, LLC Experience July 2012 - Present
Job Regulatory & Quality Consultant at Maetrics, LLC
Industry Medical Devices
Experience
Maetrics, LLC July 2012 - Present
ArthroCare Corporation June 2011 - July 2012
St. Jude Medical June 2010 - July 2011
Medtronic January 2008 - June 2010
UnitedHealth Group March 2007 - January 2008
UnitedHealth Group January 2006 - March 2007
UnitedHealth Group August 2005 - January 2006
Skills
Process Improvement, Data Analysis, Communicator, Medical Devices, FDA, CAPA, Regulatory Affairs, Quality System, Quality Auditing, Validation, Cross-functional Team..., Healthcare, Sop, DMAIC, ISO 13485, Complaint Management, Quality Management, 21 CFR Part 11, Quality Assurance, SOP
Education
University of Minnesota Crookston 2015 — 2017
Bachelor's degree, Manufacturing Management (Quality Management)
University of Minnesota-Duluth 2001 — 2004
Bachelor of Arts, Criminology
Mesabi Range Community and Technical College 1999 — 2001
A.A., Liberal Arts
Maetrics, LLC July 2012 - Present
ArthroCare Corporation June 2011 - July 2012
St. Jude Medical June 2010 - July 2011
Medtronic January 2008 - June 2010
UnitedHealth Group March 2007 - January 2008
UnitedHealth Group January 2006 - March 2007
UnitedHealth Group August 2005 - January 2006
Skills
Process Improvement, Data Analysis, Communicator, Medical Devices, FDA, CAPA, Regulatory Affairs, Quality System, Quality Auditing, Validation, Cross-functional Team..., Healthcare, Sop, DMAIC, ISO 13485, Complaint Management, Quality Management, 21 CFR Part 11, Quality Assurance, SOP
Education
University of Minnesota Crookston 2015 — 2017
Bachelor's degree, Manufacturing Management (Quality Management)
University of Minnesota-Duluth 2001 — 2004
Bachelor of Arts, Criminology
Mesabi Range Community and Technical College 1999 — 2001
A.A., Liberal Arts
Janani Nadarajah's Maetrics, LLC Experience January 2010 - 2012
Job Human Resource Manager
Industry Health, Wellness and Fitness
Experience
Sol Yoga, Inc June 2013 - Present
Maetrics, LLC January 2010 - 2012
Lonza October 2007 - July 2009
BioReliance/Invitrogen 2002 - 2004
BioReliance Inc. 2000 - 2004
Skills
Biotechnology, Validation, Technology Transfer
Education
Boston University School of Medicine 1993 — 1996
MA, Biochemistry
University of Zambia
Bachelor's degree, Biochemistry
Sol Yoga, Inc June 2013 - Present
Maetrics, LLC January 2010 - 2012
Lonza October 2007 - July 2009
BioReliance/Invitrogen 2002 - 2004
BioReliance Inc. 2000 - 2004
Skills
Biotechnology, Validation, Technology Transfer
Education
Boston University School of Medicine 1993 — 1996
MA, Biochemistry
University of Zambia
Bachelor's degree, Biochemistry
Wendi M. Lindenmuth's Maetrics, LLC Experience September 2012 - May 2014
Job Founder at Locally Baked, LLC
Industry Biotechnology
Experience
Locally Baked, LLC April 2015 - Present
Locally Geared, LLC October 2014 - Present
Maetrics, LLC September 2012 - May 2014
St. Jude Medical May 2012 - September 2012
Medtronic July 2010 - May 2012
Zimmer Spine December 2008 - June 2010
Katz Analytical Services May 2009 - May 2010
Katz Analytical Services May 2009 - May 2010
Zimmer Spine 2009 - 2010
Medtronic July 2008 - October 2008
Skills
GLP, 21 CFR Part 11, GCP, Protocol, Quality Control, Auditing, Leadership, Project Management, Research, Management, Consulting, Customer Service, Program Management, Testing, LIMS, Sop, ISO 13485, Technology Transfer, Healthcare, Lifesciences, Clinical Development, Change Control, Clinical Research, CRO, Toxicology, Biotechnology, Design Control, Laboratory, Software Documentation, Quality Assurance, CAPA, ISO, Validation, FDA, Quality System, R&D, Biomedical Engineering, Regulatory Requirements, Pharmaceutical Industry, Quality Auditing, Training, Regulatory Submissions, Computer System..., Clinical Trials, GMP, Product Development, Document Management, Quality Management, Medical Devices, Pharmaceutics
Education
Capella University 2010 — 2014
Master's Degree, Masters in Public Health, 4.0
Western Michigan University 1987 — 1997
Bachelors of Science, Education
Locally Baked, LLC April 2015 - Present
Locally Geared, LLC October 2014 - Present
Maetrics, LLC September 2012 - May 2014
St. Jude Medical May 2012 - September 2012
Medtronic July 2010 - May 2012
Zimmer Spine December 2008 - June 2010
Katz Analytical Services May 2009 - May 2010
Katz Analytical Services May 2009 - May 2010
Zimmer Spine 2009 - 2010
Medtronic July 2008 - October 2008
Skills
GLP, 21 CFR Part 11, GCP, Protocol, Quality Control, Auditing, Leadership, Project Management, Research, Management, Consulting, Customer Service, Program Management, Testing, LIMS, Sop, ISO 13485, Technology Transfer, Healthcare, Lifesciences, Clinical Development, Change Control, Clinical Research, CRO, Toxicology, Biotechnology, Design Control, Laboratory, Software Documentation, Quality Assurance, CAPA, ISO, Validation, FDA, Quality System, R&D, Biomedical Engineering, Regulatory Requirements, Pharmaceutical Industry, Quality Auditing, Training, Regulatory Submissions, Computer System..., Clinical Trials, GMP, Product Development, Document Management, Quality Management, Medical Devices, Pharmaceutics
Education
Capella University 2010 — 2014
Master's Degree, Masters in Public Health, 4.0
Western Michigan University 1987 — 1997
Bachelors of Science, Education
Debbie Nishijima's Maetrics, LLC Experience September 2013 - June 2015
Job Senior Corporate Recruiter at Gilead
Industry Biotechnology
Experience
Gilead Sciences June 2015 - Present
Maetrics, LLC September 2013 - June 2015
Kelly Services, Inc. 2008 - September 2013
List Biological Laboratories April 2001 - July 2007
Litmus Concepts/ Quidel July 1990 - March 2001
Skills
Biotechnology, Analytical Chemistry, Protein Purification, Protein Chemistry, Management, Medical Device R&D, Training, R&D, Medical Devices, Leadership, Talent Management, Lifesciences, Laboratory, Talent Acquisition, Business Development, Applicant Tracking..., Consulting, Sales, Temporary Placement, Executive Search, Technical Recruiting, Sourcing, Interviews, Vendor Management, Recruiting, Human Resources, Life Sciences
Education
Santa Clara University 1985 — 1989
Bachelor of Science (B.S.), Biology
Gilead Sciences June 2015 - Present
Maetrics, LLC September 2013 - June 2015
Kelly Services, Inc. 2008 - September 2013
List Biological Laboratories April 2001 - July 2007
Litmus Concepts/ Quidel July 1990 - March 2001
Skills
Biotechnology, Analytical Chemistry, Protein Purification, Protein Chemistry, Management, Medical Device R&D, Training, R&D, Medical Devices, Leadership, Talent Management, Lifesciences, Laboratory, Talent Acquisition, Business Development, Applicant Tracking..., Consulting, Sales, Temporary Placement, Executive Search, Technical Recruiting, Sourcing, Interviews, Vendor Management, Recruiting, Human Resources, Life Sciences
Education
Santa Clara University 1985 — 1989
Bachelor of Science (B.S.), Biology
Gloria Witt's Maetrics, LLC Experience April 2013 - May 2014
Job Quality and Regulatory Manager
Industry Medical Devices
Experience
Exel June 2014 - Present
Maetrics, LLC April 2013 - May 2014
Siemens Medical Solutions October 2005 - February 2012
Lerner, Sampson, Rothfuss April 2005 - September 2005
Skills
Negotiation, Contract Management, Legal Research, Legal Writing, Client Interfacing..., File Management, Electronic Filing, Legal Compliance, Legal Documents, Medical Devices, Regulatory Affairs, Product Development, Virtual Teams, Cross Functional..., ISO 13485, FDA GMP, ISO 14971, Regulatory Submissions, Westlaw, 21 CFR Part 11, Quality Assurance, CAPA, FDA, V&V, Program Management, Sop, Validation, Process Improvement, Quality System, SOP, Cross-functional Team..., Training
Education
Peirce College 2009 — 2014
Bachelor of Science (B.S.), Paralegal Technology
Peirce College 2005 — 2009
A.S., Paralegal Technology
University of Cincinnati 2001 — 2005
90 credits toward a BS Degree, Paralegal Technology
Exel June 2014 - Present
Maetrics, LLC April 2013 - May 2014
Siemens Medical Solutions October 2005 - February 2012
Lerner, Sampson, Rothfuss April 2005 - September 2005
Skills
Negotiation, Contract Management, Legal Research, Legal Writing, Client Interfacing..., File Management, Electronic Filing, Legal Compliance, Legal Documents, Medical Devices, Regulatory Affairs, Product Development, Virtual Teams, Cross Functional..., ISO 13485, FDA GMP, ISO 14971, Regulatory Submissions, Westlaw, 21 CFR Part 11, Quality Assurance, CAPA, FDA, V&V, Program Management, Sop, Validation, Process Improvement, Quality System, SOP, Cross-functional Team..., Training
Education
Peirce College 2009 — 2014
Bachelor of Science (B.S.), Paralegal Technology
Peirce College 2005 — 2009
A.S., Paralegal Technology
University of Cincinnati 2001 — 2005
90 credits toward a BS Degree, Paralegal Technology
Calvin Edward Bembry's Maetrics, LLC Experience September 2010 - February 2012
Job Field Sales Talent Acquisition Consultant for AtriCure, Inc.
Industry Medical Devices
Experience
AtriCure, Inc. August 2015 - Present
kp companies March 2008 - August 2015
American Senior Communities March 2012 - February 2014
Maetrics LLC September 2010 - February 2012
After Sport Group, Inc June 2004 - January 2007
Guidant/Boston Scientific Cardiovascular November 1999 - March 2004
General Motors Magnequench International March 1996 - November 1999
Skills
Talent Acquisition, Recruiting, Talent Management, Medical Devices, Leadership, Training, Sales Process, College Recruiting, Internet Recruiting, Applicant Tracking..., Executive Search, Sourcing, Deferred Compensation, Sales, Human Resources, Interviews, Business Development, Cultural Diversity, Hiring, Healthcare, Organizational..., Coaching, Team Building, Technical Recruiting, Compensation, Employee Relations, Employee Training, Time Management, Management, Building Relationships, Cold Calling, Project Planning, Leadership Development, Talent Developer, Global Talent..., Strategic Planning, Onboarding
Education
University of Tennessee-Knoxville - College of Business Administration 2008 — 2016
Master of Business Administration (M.B.A.), Intl Marketing
Indiana University - Kelley School of Business 1986 — 1991
Bachelor's Degree, Finance and Financial Management Services
Bishop Chatard
AtriCure, Inc. August 2015 - Present
kp companies March 2008 - August 2015
American Senior Communities March 2012 - February 2014
Maetrics LLC September 2010 - February 2012
After Sport Group, Inc June 2004 - January 2007
Guidant/Boston Scientific Cardiovascular November 1999 - March 2004
General Motors Magnequench International March 1996 - November 1999
Skills
Talent Acquisition, Recruiting, Talent Management, Medical Devices, Leadership, Training, Sales Process, College Recruiting, Internet Recruiting, Applicant Tracking..., Executive Search, Sourcing, Deferred Compensation, Sales, Human Resources, Interviews, Business Development, Cultural Diversity, Hiring, Healthcare, Organizational..., Coaching, Team Building, Technical Recruiting, Compensation, Employee Relations, Employee Training, Time Management, Management, Building Relationships, Cold Calling, Project Planning, Leadership Development, Talent Developer, Global Talent..., Strategic Planning, Onboarding
Education
University of Tennessee-Knoxville - College of Business Administration 2008 — 2016
Master of Business Administration (M.B.A.), Intl Marketing
Indiana University - Kelley School of Business 1986 — 1991
Bachelor's Degree, Finance and Financial Management Services
Bishop Chatard
Ed Roach's Maetrics, LLC Experience November 2011 - August 2014
Job Director, Compliance and Validation at BarryWehmiller Design Group
Industry Medical Devices
Experience
Barry-Wehmiller Design Group August 2014 - Present
Maetrics, LLC November 2011 - August 2014
Maetrics, LLC September 2010 - November 2011
Roche Diagnostics February 2008 - September 2010
Maetrics, LLC 2004 - 2008
Avon Products 2001 - 2004
Meridian Bioscience Inc. 1999 - 2001
Skills
CAPA, ISO 13485, FDA, 21 CFR Part 11, Validation, Change Control, V&V, Quality System, GMP, Computer System..., Quality Assurance, Medical Devices, Pharmaceutical Industry, Design Control, ISO 14971, Sop, GxP, Quality Auditing, Regulatory Affairs, GLP, LIMS, Technology Transfer, Regulatory Requirements, Regulatory Submissions, GAMP, Quality Control, Biopharmaceuticals, Aseptic Processing, ISO, Cleaning Validation, Biotechnology, Process Simulation, Quality Management, Root Cause Analysis, SOP, Cross-functional Team..., Process Improvement, Software Documentation, Life Sciences, Project Management, FMEA, Manufacturing, Process Validation, Management
Education
Miami University
Barry-Wehmiller Design Group August 2014 - Present
Maetrics, LLC November 2011 - August 2014
Maetrics, LLC September 2010 - November 2011
Roche Diagnostics February 2008 - September 2010
Maetrics, LLC 2004 - 2008
Avon Products 2001 - 2004
Meridian Bioscience Inc. 1999 - 2001
Skills
CAPA, ISO 13485, FDA, 21 CFR Part 11, Validation, Change Control, V&V, Quality System, GMP, Computer System..., Quality Assurance, Medical Devices, Pharmaceutical Industry, Design Control, ISO 14971, Sop, GxP, Quality Auditing, Regulatory Affairs, GLP, LIMS, Technology Transfer, Regulatory Requirements, Regulatory Submissions, GAMP, Quality Control, Biopharmaceuticals, Aseptic Processing, ISO, Cleaning Validation, Biotechnology, Process Simulation, Quality Management, Root Cause Analysis, SOP, Cross-functional Team..., Process Improvement, Software Documentation, Life Sciences, Project Management, FMEA, Manufacturing, Process Validation, Management
Education
Miami University
Jean Vander Heyden's Maetrics, LLC Experience October 2013 - December 2014
Job Post Market/MDR/Compliance Specialist
Industry Medical Devices
Experience
Fresenius Medical Care (ALKU) January 2015 - May 2015
Maetrics, LLC October 2013 - December 2014
Reglera September 2013 - December 2013
St. Jude NMD October 2012 - July 2013
Terumo Cardiovascular Systems September 2009 - August 2012
Skills
Medical Devices, CAPA, ISO 13485, Validation, ISO 14971, Change Control, Quality Auditing, Process Improvement, Minitab, Regulatory Affairs, Sop
Education
Metropolitan State University 1998 — 2006
Bachelor of Science (BS), Business Administration and Management, General
Inver Hills Community College 1983 — 1985
Associate of Science (AS), Health/Health Care Administration/Management
Fresenius Medical Care (ALKU) January 2015 - May 2015
Maetrics, LLC October 2013 - December 2014
Reglera September 2013 - December 2013
St. Jude NMD October 2012 - July 2013
Terumo Cardiovascular Systems September 2009 - August 2012
Skills
Medical Devices, CAPA, ISO 13485, Validation, ISO 14971, Change Control, Quality Auditing, Process Improvement, Minitab, Regulatory Affairs, Sop
Education
Metropolitan State University 1998 — 2006
Bachelor of Science (BS), Business Administration and Management, General
Inver Hills Community College 1983 — 1985
Associate of Science (AS), Health/Health Care Administration/Management
Andy Mayer's Maetrics, LLC Experience September 2013 - Present
Job Compliance & Quality Consultant at Maetrics, LLC
Industry Research
Experience
Maetrics, LLC September 2013 - Present
Federated Precision October 2012 - Present
Quantachrome October 2011 - October 2012
Biomet 3i March 2007 - October 2011
CBCSF 2002 - 2007
ADC Telecommunications April 1999 - April 2002
Sensormatic Electronics 1980 - 1995
Skills
Manufacturing, Quality System, Design of Experiments, Validation, Medical Devices, Lean Manufacturing, Six Sigma, ISO, ISO 13485, Kaizen, Continuous Improvement, Value Stream Mapping, GMP, Quality Assurance, Manufacturing..., 5S, Kanban, PPAP, V&V, FDA, CAPA
Education
Florida Atlantic University 1994 — 1999
Master of Science (M.S.) Minor in B.A., Engineering
Florida Atlantic University 1985 — 1990
B.S.E.E., Electrical and Electronics Engineering
Maetrics, LLC September 2013 - Present
Federated Precision October 2012 - Present
Quantachrome October 2011 - October 2012
Biomet 3i March 2007 - October 2011
CBCSF 2002 - 2007
ADC Telecommunications April 1999 - April 2002
Sensormatic Electronics 1980 - 1995
Skills
Manufacturing, Quality System, Design of Experiments, Validation, Medical Devices, Lean Manufacturing, Six Sigma, ISO, ISO 13485, Kaizen, Continuous Improvement, Value Stream Mapping, GMP, Quality Assurance, Manufacturing..., 5S, Kanban, PPAP, V&V, FDA, CAPA
Education
Florida Atlantic University 1994 — 1999
Master of Science (M.S.) Minor in B.A., Engineering
Florida Atlantic University 1985 — 1990
B.S.E.E., Electrical and Electronics Engineering
Dawnel Scott's Maetrics, LLC Experience March 2013 - November 2013
Job Regulatory and Quality
Industry Medical Devices
Experience
Cerebrotech Medical Systems November 2013 - Present
DS Consulting November 2013 - Present
Maetrics, LLC March 2013 - November 2013
TDC Medical December 2010 - January 2013
SpinalMotion April 2008 - December 2010
M2 Medical October 2007 - April 2008
Ardian, Inc. November 2005 - April 2007
NeuColl June 2000 - April 2005
Norian corp 1994 - 2000
Skills
CAPA, Manufacturing, Cross-functional Team..., Medical Devices, ISO 13485, Design Control, ISO 14971, FDA, FMEA, Validation, Quality Assurance, Quality System, V&V, Product Development, R&D, GMP, Process Improvement, Root Cause Analysis, Quality Management, Change Control, Product Launch, DMAIC, Quality Auditing, Design of Experiments, ISO, Biotechnology, Regulatory Affairs, Regulatory Submissions, Commercialization, GLP, Supplier Quality, Sop, CQA, FDA GMP, Continuous Improvement, SPC, Quality Control, CE marking, 21 CFR Part 11, Manufacturing..., Contract Manufacturing, Biomedical Engineering, Lean Manufacturing, Complaint Management, Calibration, Technology Transfer
Education
Saint Mary's College of California 2007 — 2009
MA, Leadership
Saint Mary's College of California 2001 — 2003
BA, business management
Las Positas College 1998 — 2000
AA, Liberal Arts
Elko High School 1972 — 1975
high school
Cerebrotech Medical Systems November 2013 - Present
DS Consulting November 2013 - Present
Maetrics, LLC March 2013 - November 2013
TDC Medical December 2010 - January 2013
SpinalMotion April 2008 - December 2010
M2 Medical October 2007 - April 2008
Ardian, Inc. November 2005 - April 2007
NeuColl June 2000 - April 2005
Norian corp 1994 - 2000
Skills
CAPA, Manufacturing, Cross-functional Team..., Medical Devices, ISO 13485, Design Control, ISO 14971, FDA, FMEA, Validation, Quality Assurance, Quality System, V&V, Product Development, R&D, GMP, Process Improvement, Root Cause Analysis, Quality Management, Change Control, Product Launch, DMAIC, Quality Auditing, Design of Experiments, ISO, Biotechnology, Regulatory Affairs, Regulatory Submissions, Commercialization, GLP, Supplier Quality, Sop, CQA, FDA GMP, Continuous Improvement, SPC, Quality Control, CE marking, 21 CFR Part 11, Manufacturing..., Contract Manufacturing, Biomedical Engineering, Lean Manufacturing, Complaint Management, Calibration, Technology Transfer
Education
Saint Mary's College of California 2007 — 2009
MA, Leadership
Saint Mary's College of California 2001 — 2003
BA, business management
Las Positas College 1998 — 2000
AA, Liberal Arts
Elko High School 1972 — 1975
high school
Joshua Friesenhahn's Maetrics, LLC Experience 2008 - 2009
Job Full Stack Engineer
Industry Medical Devices
Experience
SOLS August 2015 - Present
Ambit Energy July 2013 - August 2015
Ambit Energy March 2012 - June 2013
ThermoTek, Inc October 2010 - December 2011
MetLife Home Loans February 2010 - October 2010
Stryker 2008 - 2009
Maetrics LLC 2008 - 2009
Skills
Biomedical Engineering, Biomechanics, Medical Devices, Mechanical Engineering, Product Development, Analytics, Algorithm Design, Quantitative Research, VBA, C++, SQL, Matlab, NI LabVIEW, Control Logic, Computational Modeling, Predictive Modeling, Research, Experimental Design, Literature Reviews, Business Analysis, Business Intelligence, Software Engineering, FDA, Labview, Microsoft Excel, Minitab, Leadership, C#, Process Improvement, Software Development, Databases, LabVIEW
Education
LeTourneau University 2000 — 2004
Bachelor of Science, Biomedical Engineering
LeTourneau University
Bachelor of Science (BS), Biomedical/Medical Engineering
SOLS August 2015 - Present
Ambit Energy July 2013 - August 2015
Ambit Energy March 2012 - June 2013
ThermoTek, Inc October 2010 - December 2011
MetLife Home Loans February 2010 - October 2010
Stryker 2008 - 2009
Maetrics LLC 2008 - 2009
Skills
Biomedical Engineering, Biomechanics, Medical Devices, Mechanical Engineering, Product Development, Analytics, Algorithm Design, Quantitative Research, VBA, C++, SQL, Matlab, NI LabVIEW, Control Logic, Computational Modeling, Predictive Modeling, Research, Experimental Design, Literature Reviews, Business Analysis, Business Intelligence, Software Engineering, FDA, Labview, Microsoft Excel, Minitab, Leadership, C#, Process Improvement, Software Development, Databases, LabVIEW
Education
LeTourneau University 2000 — 2004
Bachelor of Science, Biomedical Engineering
LeTourneau University
Bachelor of Science (BS), Biomedical/Medical Engineering
Greg Leon's Maetrics, LLC Experience May 2013 - Present
Job Senior Compliance & Quality Engineer at Maetrics, LLC
Industry Medical Devices
Experience
Maetrics, LLC May 2013 - Present
VeraLight, Inc. May 2011 - January 2013
Luminous Medical October 2007 - March 2011
Gen-Probe 2006 - 2007
Alcon Laboratories, Inc. 1994 - 2006
Baxter Edwards Critical Care 1992 - 1993
Western Digital 1990 - 1992
Parker Hannifin 1987 - 1990
Skills
CQE, Medical Devices, ISO 13485, Quality System, Product Development, Biomedical Engineering, Manufacturing, Quality Assurance, V&V, FDA, Design Control, ISO 14971, CAPA, ISO, R&D, Certified Reliability..., Certified Biomedical..., NM State Field..., 21 CFR 820, Human Factors..., Risk Management
Education
University of Arizona 1984 — 1987
MS, Industrial Engineering
Claremont McKenna College 1977 — 1981
BA, PsychoBiology
Maetrics, LLC May 2013 - Present
VeraLight, Inc. May 2011 - January 2013
Luminous Medical October 2007 - March 2011
Gen-Probe 2006 - 2007
Alcon Laboratories, Inc. 1994 - 2006
Baxter Edwards Critical Care 1992 - 1993
Western Digital 1990 - 1992
Parker Hannifin 1987 - 1990
Skills
CQE, Medical Devices, ISO 13485, Quality System, Product Development, Biomedical Engineering, Manufacturing, Quality Assurance, V&V, FDA, Design Control, ISO 14971, CAPA, ISO, R&D, Certified Reliability..., Certified Biomedical..., NM State Field..., 21 CFR 820, Human Factors..., Risk Management
Education
University of Arizona 1984 — 1987
MS, Industrial Engineering
Claremont McKenna College 1977 — 1981
BA, PsychoBiology
Dean Haggen's Maetrics, LLC Experience October 2013 - Present
Job Sr. Compliance and Quality Engineer at Maetrics, LLC
Industry Medical Devices
Experience
Maetrics, LLC October 2013 - Present
Oxford International March 2012 - August 2013
Gore June 2006 - March 2012
BD March 2004 - June 2006
Cyberonics June 2002 - March 2004
CR Bard July 1994 - June 2002
Skills
CAPA, ISO 13485, Lean Manufacturing, SPC, Design of Experiments, Quality System, V&V, GMP, Medical Devices, Validation, Manufacturing, Process Simulation, Solidworks, Product Development, PFMEA, Design Control, Design for Manufacturing, Manufacturing..., DMAIC, Injection Molding, Root Cause Analysis, FDA, Minitab, ISO 14971, FMEA, ISO, Process Improvement, Supplier Quality, 5S, Value Stream Mapping, Gage R&R, Six Sigma, SolidWorks
Education
Brigham Young University 1990 — 1993
Bachelor of Applied Science (B.A.Sc.), Manufacturing Engineering Technology
Brigham Young University 1990 — 1993
Bachelor of Applied Science (BASc), Manufacturing Engineering Technology/Technician
Maetrics, LLC October 2013 - Present
Oxford International March 2012 - August 2013
Gore June 2006 - March 2012
BD March 2004 - June 2006
Cyberonics June 2002 - March 2004
CR Bard July 1994 - June 2002
Skills
CAPA, ISO 13485, Lean Manufacturing, SPC, Design of Experiments, Quality System, V&V, GMP, Medical Devices, Validation, Manufacturing, Process Simulation, Solidworks, Product Development, PFMEA, Design Control, Design for Manufacturing, Manufacturing..., DMAIC, Injection Molding, Root Cause Analysis, FDA, Minitab, ISO 14971, FMEA, ISO, Process Improvement, Supplier Quality, 5S, Value Stream Mapping, Gage R&R, Six Sigma, SolidWorks
Education
Brigham Young University 1990 — 1993
Bachelor of Applied Science (B.A.Sc.), Manufacturing Engineering Technology
Brigham Young University 1990 — 1993
Bachelor of Applied Science (BASc), Manufacturing Engineering Technology/Technician
Candida Tomlin's Maetrics, LLC Experience 2005 - 2006
Job Senior Quality Manager at ABSG
Industry Pharmaceuticals
Experience
ABSG September 2006 - Present
Maetrics, LLC 2005 - 2006
Skills
FDA, ISO, cGMP, Documentation, Quality Assurance, Mentoring, Coaching, CAPA, Computer System..., 21 CFR Part 11, Process Validation, Validation, Change Control, Auditing, Continuous Improvement, GMP, Quality Management, Sop, ISO 13485, Iso 9000, Six Sigma, V&V, Quality System, Process Improvement, Cross-functional Team..., SOP
Education
Indiana University Bloomington 1993 — 1995
Bachelor of Science (BS), Microbiology, General
Indiana University-Southeast 1990 — 1993
ABSG September 2006 - Present
Maetrics, LLC 2005 - 2006
Skills
FDA, ISO, cGMP, Documentation, Quality Assurance, Mentoring, Coaching, CAPA, Computer System..., 21 CFR Part 11, Process Validation, Validation, Change Control, Auditing, Continuous Improvement, GMP, Quality Management, Sop, ISO 13485, Iso 9000, Six Sigma, V&V, Quality System, Process Improvement, Cross-functional Team..., SOP
Education
Indiana University Bloomington 1993 — 1995
Bachelor of Science (BS), Microbiology, General
Indiana University-Southeast 1990 — 1993
Patrick H Baker's Maetrics, LLC Experience 2008 - June 2011
Job DIRECTOR PRODUCT MANAGEMENT: QUALITY AND REGULATORY COMPLIANCE, MARKET RESEARCH, and BUSINESS DIAGNOSTICS
Industry Market Research
Experience
Oakworks, Inc March 2015 - Present
McNeil Consumer Healthcare August 2012 - January 2015
Resources Global Professionals June 2012 - August 2012
MedImmune 2011 - 2012
Maetrics, LLC 2008 - June 2011
Lonza 2007 - 2008
Invitrogen 2005 - 2006
Sandoz Pharmaceuticals 2003 - 2005
TIMET 1998 - 2002
Skills
Quality System, Six Sigma, Lean Manufacturing, Process Improvement, Operational Excellence, Supply Chain, Change Management, Business Process, Sop, Design of Experiments, Cross-functional Team..., Continuous Improvement, Biotechnology, Manufacturing, Value Stream Mapping, Program Management, FDA, Management, Leadership, Quality Management, Root Cause Analysis
Education
University of California, Santa Barbara 1987 — 1990
MS, Engineering Materials
Michigan Technological University 1983 — 1987
BS, Metallurgical Engineering
Oakworks, Inc March 2015 - Present
McNeil Consumer Healthcare August 2012 - January 2015
Resources Global Professionals June 2012 - August 2012
MedImmune 2011 - 2012
Maetrics, LLC 2008 - June 2011
Lonza 2007 - 2008
Invitrogen 2005 - 2006
Sandoz Pharmaceuticals 2003 - 2005
TIMET 1998 - 2002
Skills
Quality System, Six Sigma, Lean Manufacturing, Process Improvement, Operational Excellence, Supply Chain, Change Management, Business Process, Sop, Design of Experiments, Cross-functional Team..., Continuous Improvement, Biotechnology, Manufacturing, Value Stream Mapping, Program Management, FDA, Management, Leadership, Quality Management, Root Cause Analysis
Education
University of California, Santa Barbara 1987 — 1990
MS, Engineering Materials
Michigan Technological University 1983 — 1987
BS, Metallurgical Engineering
Brian Gard's Maetrics, LLC Experience May 2013 - Present
Job Compliance and Quality Consultant at Maetrics, LLC
Industry Medical Devices
Experience
Maetrics, LLC May 2013 - Present
Cummins Inc. August 2011 - May 2013
Various Medical Device Companies 2008 - September 2011
Performance Driven LLC 2006 - 2011
Greatbatch, Inc. 2010 - 2010
Real Images December 2009 - 2010
Validant Consulting 2009 - 2009
Batesville Casket Company 2005 - 2008
Hill-Rom 2001 - 2004
Cummins, Inc 1999 - 2001
Skills
Six Sigma, FDA GMP, Validation, CAPA, Remediation, Quality Management, 21 CFR Part 11, CFR, Black Belt, Corrective Actions, Program Management, ISO 13485, New Product Validation, Supplier Quality, Lean Manufacturing, Quality System, Automotive, Medical Devices, Project Management, Quality Assurance, Quality Control, Continuous Improvement, Cross-functional Team..., Product Development
Education
Xavier University 2006 — 2006
Six Sigma Black Belt
Indiana State University 1989 — 1994
BS, EET
Maetrics, LLC May 2013 - Present
Cummins Inc. August 2011 - May 2013
Various Medical Device Companies 2008 - September 2011
Performance Driven LLC 2006 - 2011
Greatbatch, Inc. 2010 - 2010
Real Images December 2009 - 2010
Validant Consulting 2009 - 2009
Batesville Casket Company 2005 - 2008
Hill-Rom 2001 - 2004
Cummins, Inc 1999 - 2001
Skills
Six Sigma, FDA GMP, Validation, CAPA, Remediation, Quality Management, 21 CFR Part 11, CFR, Black Belt, Corrective Actions, Program Management, ISO 13485, New Product Validation, Supplier Quality, Lean Manufacturing, Quality System, Automotive, Medical Devices, Project Management, Quality Assurance, Quality Control, Continuous Improvement, Cross-functional Team..., Product Development
Education
Xavier University 2006 — 2006
Six Sigma Black Belt
Indiana State University 1989 — 1994
BS, EET
Kimberly Harvey's Maetrics, LLC Experience October 2012 - Present
Job Pharmaceutical Consultant
Industry Pharmaceuticals
Experience
GMPworx LLC February 2011 - Present
PAREXEL February 2013 - Present
Maetrics, LLC October 2012 - Present
Quintiles 2011 - Present
Intercell October 2008 - January 2011
Iomai Corporation (acquired by Intercell) July 2004 - October 2008
World Travel, a 2.5 year adventure August 2001 - March 2004
SAIC/National Cancer Institue July 1999 - August 2001
Novartis/ Ciba Vision April 1998 - March 1999
Millennium Pharmaceuticals August 1996 - August 1997
Skills
FDA, Biotechnology, Validation, Pharmaceutical Industry, CAPA, GMP, Vaccines, Technology Transfer, Sop, Biopharmaceuticals, Quality System
Education
The Johns Hopkins University 2000 — 2001
Graduate Studies - Biochemistry
Georgia State University
BS, Medical Technology
GMPworx LLC February 2011 - Present
PAREXEL February 2013 - Present
Maetrics, LLC October 2012 - Present
Quintiles 2011 - Present
Intercell October 2008 - January 2011
Iomai Corporation (acquired by Intercell) July 2004 - October 2008
World Travel, a 2.5 year adventure August 2001 - March 2004
SAIC/National Cancer Institue July 1999 - August 2001
Novartis/ Ciba Vision April 1998 - March 1999
Millennium Pharmaceuticals August 1996 - August 1997
Skills
FDA, Biotechnology, Validation, Pharmaceutical Industry, CAPA, GMP, Vaccines, Technology Transfer, Sop, Biopharmaceuticals, Quality System
Education
The Johns Hopkins University 2000 — 2001
Graduate Studies - Biochemistry
Georgia State University
BS, Medical Technology
Ambra McCain-Roby's Maetrics, LLC Experience September 2005 - January 2007
Job
Industry Biotechnology
Experience
Black Diamond Networks April 2014 - June 2014
Black Diamond Networks October 2013 - March 2014
Validant July 2013 - October 2013
Black Diamond Networks August 2012 - June 2013
Oxford International May 2011 - July 2012
Innovations Consulting Group, LLC February 2007 - March 2011
Maetrics, LLC September 2005 - January 2007
Skills
Quality Assurance, Employee Training, Risk Management, FDA, ISO 13485, Quality System, Validation, Software Documentation, Sop, Team Building, Program Management, Manufacturing..., CAPA, Team Leadership, Quality Control, Cross-functional Team..., Medical Devices, Clinical Trials, Six Sigma, Quality Management, Process Simulation, Biotechnology, Process Improvement, Regulatory Affairs, Quality Auditing, Lifesciences, Lean Manufacturing, Iso 9000, GMP, FMEA, Testing, Document Management, Pharmaceutical Industry, Clinical Development, Management, Product Development, R&D, Root Cause Analysis, Manufacturing, ISO, Technology Transfer, Operational Excellence, Change Management, SPC, Product Launch, Business Process..., Value Stream Mapping, Kaizen, Training, Strategic Planning
Education
Northeastern University 2012 — 2016
Master of Science (M.S.), Regulatory Affairs for Drugs, Biologics and Medical Devices
Marian University 1998 — 2000
Bachelor of Science (B.S.), Biology and Chemistry
Black Diamond Networks April 2014 - June 2014
Black Diamond Networks October 2013 - March 2014
Validant July 2013 - October 2013
Black Diamond Networks August 2012 - June 2013
Oxford International May 2011 - July 2012
Innovations Consulting Group, LLC February 2007 - March 2011
Maetrics, LLC September 2005 - January 2007
Skills
Quality Assurance, Employee Training, Risk Management, FDA, ISO 13485, Quality System, Validation, Software Documentation, Sop, Team Building, Program Management, Manufacturing..., CAPA, Team Leadership, Quality Control, Cross-functional Team..., Medical Devices, Clinical Trials, Six Sigma, Quality Management, Process Simulation, Biotechnology, Process Improvement, Regulatory Affairs, Quality Auditing, Lifesciences, Lean Manufacturing, Iso 9000, GMP, FMEA, Testing, Document Management, Pharmaceutical Industry, Clinical Development, Management, Product Development, R&D, Root Cause Analysis, Manufacturing, ISO, Technology Transfer, Operational Excellence, Change Management, SPC, Product Launch, Business Process..., Value Stream Mapping, Kaizen, Training, Strategic Planning
Education
Northeastern University 2012 — 2016
Master of Science (M.S.), Regulatory Affairs for Drugs, Biologics and Medical Devices
Marian University 1998 — 2000
Bachelor of Science (B.S.), Biology and Chemistry
Tina Meier's Maetrics, LLC Experience April 2012 - Present
Job Compliance & Quality Consultant at Maetrics, LLC
Industry Pharmaceuticals
Experience
Maetrics, LLC April 2012 - Present
Skills
Quality System, FDA, CAPA, 21 CFR Part 11, Validation, Computer System..., V&V, Sop, Quality Auditing, Change Control, ISO 13485, GMP, LIMS, Pharmaceutical Industry, Regulatory Affairs
Education
Indiana Wesleyan University 2010 — 2012
MBA
Maetrics, LLC April 2012 - Present
Skills
Quality System, FDA, CAPA, 21 CFR Part 11, Validation, Computer System..., V&V, Sop, Quality Auditing, Change Control, ISO 13485, GMP, LIMS, Pharmaceutical Industry, Regulatory Affairs
Education
Indiana Wesleyan University 2010 — 2012
MBA
Lori DonDiego's Maetrics, LLC Experience February 2010 - May 2010
Job Senior Manager, Regulatory Affairs at Cerus
Industry Medical Devices
Experience
Cerus January 2013 - Present
Thoratec 2010 - January 2013
Maetrics, LLC February 2010 - May 2010
AngioScore 2008 - 2010
Asthmatx 2004 - 2008
Coapt Systems, Inc. 2003 - 2004
Baxter Healthcare (acquired Fusion Medical Technologies in 2002) 2000 - 2003
Advocet Medical 1999 - 2000
LifeScan 1992 - 1999
Skills
Medical Device..., Summary Technical..., Labeling, Advertising..., Standard Operating..., Adverse Event Reporting, Risk assessment..., FDA, Sop, Electronic Submissions, European Union, Medical Devices, Risk Assessment
Education
SAI Global
RABQSA, Certified FDA Regulated Industries Lead Auditor (ISO9001/ISO13485), Quality Systems
Regulatory Affairs Professional Society (RAPS)
RAC (US)
Saint Mary's College of California
Master of Business Administration (MBA)
University of California, Irvine
Bachelor of Science (BS), Chemistry
Cerus January 2013 - Present
Thoratec 2010 - January 2013
Maetrics, LLC February 2010 - May 2010
AngioScore 2008 - 2010
Asthmatx 2004 - 2008
Coapt Systems, Inc. 2003 - 2004
Baxter Healthcare (acquired Fusion Medical Technologies in 2002) 2000 - 2003
Advocet Medical 1999 - 2000
LifeScan 1992 - 1999
Skills
Medical Device..., Summary Technical..., Labeling, Advertising..., Standard Operating..., Adverse Event Reporting, Risk assessment..., FDA, Sop, Electronic Submissions, European Union, Medical Devices, Risk Assessment
Education
SAI Global
RABQSA, Certified FDA Regulated Industries Lead Auditor (ISO9001/ISO13485), Quality Systems
Regulatory Affairs Professional Society (RAPS)
RAC (US)
Saint Mary's College of California
Master of Business Administration (MBA)
University of California, Irvine
Bachelor of Science (BS), Chemistry
Joe Simon's Maetrics, LLC Experience June 2009 - April 2013
Job Solutions Delivery Manager at MAETRICS
Industry Management Consulting
Experience
MAETRICS April 2013 - Present
Maetrics, LLC June 2009 - April 2013
Maetrics, LLC. October 2008 - June 2009
Maetrics, LLC. 2005 - 2008
Schwarz Pharma 2004 - 2005
Solvay Pharmaceuticals 1996 - 2002
MVTL 1991 - 1996
Education
Jones International University
Master of Business Administration (MBA)
Bemidji State University
BS, Chemistry
St. Olaf College
Biology/Chemistry Study
MAETRICS April 2013 - Present
Maetrics, LLC June 2009 - April 2013
Maetrics, LLC. October 2008 - June 2009
Maetrics, LLC. 2005 - 2008
Schwarz Pharma 2004 - 2005
Solvay Pharmaceuticals 1996 - 2002
MVTL 1991 - 1996
Education
Jones International University
Master of Business Administration (MBA)
Bemidji State University
BS, Chemistry
St. Olaf College
Biology/Chemistry Study
Laura Hamke's Maetrics, LLC Experience 2012 - 2013
Job President/ CEO at Hamke East Consulting, Inc.
Industry Medical Devices
Experience
Hamke East Consulting, Inc. February 2003 - Present
Maetrics, LLC 2012 - 2013
COR Therapeutics 1995 - 1997
Skills
Quality Assurance, Pharmaceutics, Medical Devices, Auditing, CAPA, FDA, Biotechnology, Product Development, GMP, Project Management, Pharmaceutical Industry, ISO 13485, Quality System, 21 CFR Part 11, Validation, SOP
Education
American InterContinental University 2012 — 2013
Master of Business Administration (M.B.A.), Business Administration/Project Management
American InterContinental University 2010 — 2012
Bachelor's Degree, Business Administration and Management, General
University of San Francisco 1977 — 1979
Business Administration
Hamke East Consulting, Inc. February 2003 - Present
Maetrics, LLC 2012 - 2013
COR Therapeutics 1995 - 1997
Skills
Quality Assurance, Pharmaceutics, Medical Devices, Auditing, CAPA, FDA, Biotechnology, Product Development, GMP, Project Management, Pharmaceutical Industry, ISO 13485, Quality System, 21 CFR Part 11, Validation, SOP
Education
American InterContinental University 2012 — 2013
Master of Business Administration (M.B.A.), Business Administration/Project Management
American InterContinental University 2010 — 2012
Bachelor's Degree, Business Administration and Management, General
University of San Francisco 1977 — 1979
Business Administration
Frank Lloyd's Maetrics, LLC Experience November 2011 - January 2012
Job Sr Process Development Engineer at Micell Technologies
Industry Medical Devices
Experience
Micell Technologies January 2012 - Present
Maetrics, LLC November 2011 - January 2012
MedVenture Technology June 2002 - August 2011
PURITAN BENNETT DIVISION of TYCO Healthcare July 1999 - April 2002
Delphi Automotive System (Delco Remy) July 1994 - July 1999
Navistar International (Harvester) May 1991 - November 1993
Skills
product & process..., Process Validation, Cost Reduction, V&V, Manufacturing, Medical Devices, PPAP, Design Control, Quality System, ISO 13485, Design of Experiments, Product Design, Validation, R&D, FMEA, Process Simulation, Design for Manufacturing, Product Development, Root Cause Analysis, Lean Manufacturing, Process Improvement, CAPA, Testing, SPC, Minitab, FDA, Continuous Improvement, DMAIC, Six Sigma
Education
Indiana State University 1988 — 1993
BS, Indutrial Technology
Micell Technologies January 2012 - Present
Maetrics, LLC November 2011 - January 2012
MedVenture Technology June 2002 - August 2011
PURITAN BENNETT DIVISION of TYCO Healthcare July 1999 - April 2002
Delphi Automotive System (Delco Remy) July 1994 - July 1999
Navistar International (Harvester) May 1991 - November 1993
Skills
product & process..., Process Validation, Cost Reduction, V&V, Manufacturing, Medical Devices, PPAP, Design Control, Quality System, ISO 13485, Design of Experiments, Product Design, Validation, R&D, FMEA, Process Simulation, Design for Manufacturing, Product Development, Root Cause Analysis, Lean Manufacturing, Process Improvement, CAPA, Testing, SPC, Minitab, FDA, Continuous Improvement, DMAIC, Six Sigma
Education
Indiana State University 1988 — 1993
BS, Indutrial Technology
Gunter Frey's Maetrics, LLC Experience March 2013 - February 2014
Job Senior Compliance and Quality Consultant
Industry Medical Devices
Experience
Maetrics, LLC March 2013 - February 2014
Philips Healthcare April 2010 - November 2013
Global Harmonization Task Force 2007 - 2012
Philips Healthcare July 2008 - April 2010
GE Healthcare October 1998 - July 2008
Pryon Corporation April 1994 - October 1998
Mortara Instrument February 1989 - April 1994
Skills
Quality System, Regulatory Submissions, ISO 13485, FDA, CAPA, Medical Devices, ISO 14971, Design Control, Regulatory Affairs, V&V, Quality Auditing, Standards Development, CE marking, GMP, Validation, Quality Management, Auditing, Biomedical Engineering, Cross-functional Team..., DMAIC, FDA GMP, ISO, Internal Audit, Iso 9000, Process Improvement, Manufacturing, Product Development, Quality Assurance, Quality Control, Regulatory Requirements, Six Sigma, Root Cause Analysis, ISO 9000
Education
Technische Hochschule Mittelhessen 1982 — 1988
Dipl. Ing. (FH) Biomedizinische Technik, Biomedical Engineering
Maetrics, LLC March 2013 - February 2014
Philips Healthcare April 2010 - November 2013
Global Harmonization Task Force 2007 - 2012
Philips Healthcare July 2008 - April 2010
GE Healthcare October 1998 - July 2008
Pryon Corporation April 1994 - October 1998
Mortara Instrument February 1989 - April 1994
Skills
Quality System, Regulatory Submissions, ISO 13485, FDA, CAPA, Medical Devices, ISO 14971, Design Control, Regulatory Affairs, V&V, Quality Auditing, Standards Development, CE marking, GMP, Validation, Quality Management, Auditing, Biomedical Engineering, Cross-functional Team..., DMAIC, FDA GMP, ISO, Internal Audit, Iso 9000, Process Improvement, Manufacturing, Product Development, Quality Assurance, Quality Control, Regulatory Requirements, Six Sigma, Root Cause Analysis, ISO 9000
Education
Technische Hochschule Mittelhessen 1982 — 1988
Dipl. Ing. (FH) Biomedizinische Technik, Biomedical Engineering
Eric Darcy's Maetrics, LLC Experience 2013 - 2013
Job Quality Engineer at AlterG
Industry Medical Devices
Experience
AlterG June 2014 - Present
DRC Contract Quality Assurance Specialist July 2012 - Present
Maquet Getinge Group January 2014 - April 2014
Johnson & Johnson April 2013 - October 2013
HeartWare Inc October 2011 - April 2013
Maetrics, LLC 2013 - 2013
Maetrics, LLC 2013 - 2013
Oxford Global Resources October 2011 - May 2012
Screen-Tech, Inc May 2010 - March 2011
Fantastic Fan Filters LLC 2009 - 2011
Skills
Certified Quality..., Six Sigma, ISO 13485, CAPA, Engineering Change..., Change Control Board, ISO 9000, Supplier Risk Management, Supplier Quality..., Supplier Evaluation, Supplier Performance, Iso 9000, CQA, DMAIC, Electronics, SPC, Manufacturing, Engineering, Design of Experiments, Quality Control, Quality Assurance, Supplier Quality
Education
San Jose State University 2001 — 2003
MS, Quality Assurance
California State University-Chico 1988 — 1992
BS, Electronic & Computer Technology
AlterG June 2014 - Present
DRC Contract Quality Assurance Specialist July 2012 - Present
Maquet Getinge Group January 2014 - April 2014
Johnson & Johnson April 2013 - October 2013
HeartWare Inc October 2011 - April 2013
Maetrics, LLC 2013 - 2013
Maetrics, LLC 2013 - 2013
Oxford Global Resources October 2011 - May 2012
Screen-Tech, Inc May 2010 - March 2011
Fantastic Fan Filters LLC 2009 - 2011
Skills
Certified Quality..., Six Sigma, ISO 13485, CAPA, Engineering Change..., Change Control Board, ISO 9000, Supplier Risk Management, Supplier Quality..., Supplier Evaluation, Supplier Performance, Iso 9000, CQA, DMAIC, Electronics, SPC, Manufacturing, Engineering, Design of Experiments, Quality Control, Quality Assurance, Supplier Quality
Education
San Jose State University 2001 — 2003
MS, Quality Assurance
California State University-Chico 1988 — 1992
BS, Electronic & Computer Technology
Andy Grom's Maetrics, LLC Experience November 2009 - July 2010
Job Director of Quality at Cardiac Science Inc
Industry Medical Devices
Experience
Cardiac Science Inc July 2014 - Present
Cardiac Sciences June 2012 - June 2014
Baxter Healthcare May 2011 - June 2012
Validant November 2010 - April 2011
Maetrics LLC November 2009 - July 2010
Gendex Dental Systems 2008 - 2009
Ohio Medical Corporation 2005 - 2008
Skills
Quality Systems, FDA, Inspection, ISO 13485, Medical Devices, CAPA, ISO, Validation, cGMP, GMP, Quality Assurance, Lean Manufacturing, Compliance, Process Improvement, Continuous Improvement, Pharmaceuticals, Testing, Auditing, Quality Management, Documentation, QSR, 21 CFR Part 11, Software Documentation, Quality System, Quality Auditing, Pharmaceutical Industry, Computer System..., ISO 14971, Sop, Six Sigma, Change Control, Manufacturing, Supplier Quality, Design Control, Process Simulation, Root Cause Analysis, GLP, R&D, Quality Control, V&V, SPC, Minitab, Regulatory Requirements, Regulatory Affairs, FMEA, GxP, DMAIC, Complaint Management, Cross-functional Team..., Biotechnology
Education
Waukegan West High School 1974 — 1978
College Prep
University of Kansas
Bachelor of Arts (BA)
Cardiac Science Inc July 2014 - Present
Cardiac Sciences June 2012 - June 2014
Baxter Healthcare May 2011 - June 2012
Validant November 2010 - April 2011
Maetrics LLC November 2009 - July 2010
Gendex Dental Systems 2008 - 2009
Ohio Medical Corporation 2005 - 2008
Skills
Quality Systems, FDA, Inspection, ISO 13485, Medical Devices, CAPA, ISO, Validation, cGMP, GMP, Quality Assurance, Lean Manufacturing, Compliance, Process Improvement, Continuous Improvement, Pharmaceuticals, Testing, Auditing, Quality Management, Documentation, QSR, 21 CFR Part 11, Software Documentation, Quality System, Quality Auditing, Pharmaceutical Industry, Computer System..., ISO 14971, Sop, Six Sigma, Change Control, Manufacturing, Supplier Quality, Design Control, Process Simulation, Root Cause Analysis, GLP, R&D, Quality Control, V&V, SPC, Minitab, Regulatory Requirements, Regulatory Affairs, FMEA, GxP, DMAIC, Complaint Management, Cross-functional Team..., Biotechnology
Education
Waukegan West High School 1974 — 1978
College Prep
University of Kansas
Bachelor of Arts (BA)
Leanne Cobb's Maetrics, LLC Experience March 2013 - Present
Job ES&H Manager at Maetrics, LLC
Industry Medical Devices
Experience
Maetrics, LLC March 2013 - Present
Triumph Aerostructures-Vought Aircraft Division 2008 - November 2012
Teknor Apex Company April 2001 - July 2008
Cambridge Analytical 1977 - 1983
Skills
Industrial Hygiene, EHS, Industrial Safety, Safety Management, Hazardous Waste..., Environmental Compliance, Accident Investigation, Waste Management, Emergency Management, Hazardous Materials, Environmental, Safety Engineering, RCRA, Permitting, Safety Management..., Environmental Awareness, Environmental Permitting, EPA, Occupational Health, HAZWOPER, Root Cause Analysis, Environmental Consulting, Environmental..., ISO, Ergonomics, Remediation
Education
Simmons College - Simmons School of Management 1983 — 1984
MBA
Boston College 1975 — 1979
BA, Psychology/Biology
Manter Hall 1973 — 1975
HS Diploma
Maetrics, LLC March 2013 - Present
Triumph Aerostructures-Vought Aircraft Division 2008 - November 2012
Teknor Apex Company April 2001 - July 2008
Cambridge Analytical 1977 - 1983
Skills
Industrial Hygiene, EHS, Industrial Safety, Safety Management, Hazardous Waste..., Environmental Compliance, Accident Investigation, Waste Management, Emergency Management, Hazardous Materials, Environmental, Safety Engineering, RCRA, Permitting, Safety Management..., Environmental Awareness, Environmental Permitting, EPA, Occupational Health, HAZWOPER, Root Cause Analysis, Environmental Consulting, Environmental..., ISO, Ergonomics, Remediation
Education
Simmons College - Simmons School of Management 1983 — 1984
MBA
Boston College 1975 — 1979
BA, Psychology/Biology
Manter Hall 1973 — 1975
HS Diploma
Nicolle Jordan's Maetrics, LLC Experience February 2008 - September 2009
Job Sr Representative QA at Eli Lilly and Company
Industry Pharmaceuticals
Experience
Eli Lilly and Company September 2009 - Present
Maetrics, LLC February 2008 - September 2009
Pfizer 2007 - 2008
Pfizer 2006 - 2007
Skills
Change Control, Quality Assurance, 21 CFR Part 11, CAPA, Validation, GMP, FDA, Quality System, GxP, Quality Auditing, Pharmaceutical Industry, Continuous Improvement, Process Improvement, Microsoft Excel, Microsoft Office, Regulatory Affairs, Regulatory Requirements, Root Cause Analysis, Quality Control, PowerPoint, GLP, LIMS, Document Management, Sop, Aseptic Processing
Education
Indiana State University 2000 — 2005
BS, Biology major/Chem & Spanish minor
Rose-Hulman Institute of Technology
*MS, Engineering Management
Eli Lilly and Company September 2009 - Present
Maetrics, LLC February 2008 - September 2009
Pfizer 2007 - 2008
Pfizer 2006 - 2007
Skills
Change Control, Quality Assurance, 21 CFR Part 11, CAPA, Validation, GMP, FDA, Quality System, GxP, Quality Auditing, Pharmaceutical Industry, Continuous Improvement, Process Improvement, Microsoft Excel, Microsoft Office, Regulatory Affairs, Regulatory Requirements, Root Cause Analysis, Quality Control, PowerPoint, GLP, LIMS, Document Management, Sop, Aseptic Processing
Education
Indiana State University 2000 — 2005
BS, Biology major/Chem & Spanish minor
Rose-Hulman Institute of Technology
*MS, Engineering Management
Bruce Corwin's Maetrics, LLC Experience September 2013 - December 2014
Job Solutions Delivery Manager at MAETRICS
Industry Medical Devices
Experience
MAETRICS January 2015 - Present
Maetrics, LLC September 2013 - December 2014
Baxter International Inc. 2008 - 2012
Baxter International Inc. 2007 - 2008
Baxter International Inc. 2004 - 2007
Baxter International Inc. 2000 - 2004
Baxter International Inc. 1998 - 2000
Baxter International Inc. 1994 - 1998
Baxter International Inc. 1989 - 1994
Baxter International Inc. 1986 - 1989
Skills
Medical Devices, FDA, Sop, CAPA, Design Control, ISO 13485, Quality Management, Quality Assurance, Quality System, ISO 14971, Manufacturing, GMP, V&V, Lean Manufacturing, Validation, Root Cause Analysis, Quality Control, DMAIC, Calibration, Supplier Quality, Testing, Quality Auditing, ISO, FMEA, 21 CFR Part 11, Value Stream Mapping, SPC, Product Development, Manufacturing..., Six Sigma, Continuous Improvement, Engineering, 5S, R&D, Electronics, Manufacturing..., Kaizen, Change Control, Design for Manufacturing, Design of Experiments, Cross-functional Team..., Process Capability, Operational Excellence, Computer System..., Minitab, CQA, FDA GMP, Process Improvement, Iso 9000, SOP
Education
University of South Florida 2014 — 2016
Master of Business Administration (M.B.A.), Business, Management, Marketing, and Related Support Services
St. Petersburg College
Bachelor of Applied Science (B.A.Sc.), Management and Organizational Leadership, 3.8
MAETRICS January 2015 - Present
Maetrics, LLC September 2013 - December 2014
Baxter International Inc. 2008 - 2012
Baxter International Inc. 2007 - 2008
Baxter International Inc. 2004 - 2007
Baxter International Inc. 2000 - 2004
Baxter International Inc. 1998 - 2000
Baxter International Inc. 1994 - 1998
Baxter International Inc. 1989 - 1994
Baxter International Inc. 1986 - 1989
Skills
Medical Devices, FDA, Sop, CAPA, Design Control, ISO 13485, Quality Management, Quality Assurance, Quality System, ISO 14971, Manufacturing, GMP, V&V, Lean Manufacturing, Validation, Root Cause Analysis, Quality Control, DMAIC, Calibration, Supplier Quality, Testing, Quality Auditing, ISO, FMEA, 21 CFR Part 11, Value Stream Mapping, SPC, Product Development, Manufacturing..., Six Sigma, Continuous Improvement, Engineering, 5S, R&D, Electronics, Manufacturing..., Kaizen, Change Control, Design for Manufacturing, Design of Experiments, Cross-functional Team..., Process Capability, Operational Excellence, Computer System..., Minitab, CQA, FDA GMP, Process Improvement, Iso 9000, SOP
Education
University of South Florida 2014 — 2016
Master of Business Administration (M.B.A.), Business, Management, Marketing, and Related Support Services
St. Petersburg College
Bachelor of Applied Science (B.A.Sc.), Management and Organizational Leadership, 3.8
Val Uriegas's Maetrics, LLC Experience April 2013 - Present
Job Senior Compliance and Quality Consultant at Maetrics, LLC
Industry Medical Devices
Experience
Maetrics, LLC April 2013 - Present
Covidien July 2011 - February 2013
Boston Scientific March 2011 - July 2011
Boston Scientific June 2007 - March 2011
TEXAS DEPARTMENT OF STATE HEALTH SERVICES March 2003 - June 2007
TEXAS DEPARTMENT OF STATE HEALTH SERVICES January 2002 - March 2003
TEXAS DEPARTMENT OF STATE HEALTH SERVICES 2000 - 2002
TEXAS DEPARTMENT OF STATE HEALTH 1997 - 2000
Skills
RABSQSA ISO 13485:2003..., CERTIFIED REGULATORY..., CERTIFIED QUALITY..., Design Control, Quality System, CAPA, FDA, ISO 13485, GMP, Quality Auditing, Medical Devices, Regulatory Affairs, Sop, Software Documentation, Auditing, 21 CFR, Internal Audit, ISO
Education
The University of Texas at Austin 1989 — 1997
Bachelor of Science (B.S.), Nutrition Sciences
Maetrics, LLC April 2013 - Present
Covidien July 2011 - February 2013
Boston Scientific March 2011 - July 2011
Boston Scientific June 2007 - March 2011
TEXAS DEPARTMENT OF STATE HEALTH SERVICES March 2003 - June 2007
TEXAS DEPARTMENT OF STATE HEALTH SERVICES January 2002 - March 2003
TEXAS DEPARTMENT OF STATE HEALTH SERVICES 2000 - 2002
TEXAS DEPARTMENT OF STATE HEALTH 1997 - 2000
Skills
RABSQSA ISO 13485:2003..., CERTIFIED REGULATORY..., CERTIFIED QUALITY..., Design Control, Quality System, CAPA, FDA, ISO 13485, GMP, Quality Auditing, Medical Devices, Regulatory Affairs, Sop, Software Documentation, Auditing, 21 CFR, Internal Audit, ISO
Education
The University of Texas at Austin 1989 — 1997
Bachelor of Science (B.S.), Nutrition Sciences
Frances (Frankie) Soliven-Meglin's Maetrics, LLC Experience February 2014 - April 2015
Job GHS Labeling Specialist Regulatory Environment at Adecco Technical Staffing
Industry Graphic Design
Experience
Adecco Technical Staffing May 2015 - Present
Graphic Communicators January 2002 - Present
Maetrics, LLC February 2014 - April 2015
Thermo Fisher Scientific 2015 - 2015
Thermo Fisher Scientific 2015 - 2015
Thermo Fisher Scientific 2015 - 2015
Thermo Fisher Scientific 2015 - 2015
MAETRICS 2014 - 2015
MAETRICS 2014 - 2015
MAETRICS 2014 - 2015
Skills
PC Computer, Mac OS X, Graphic Design, Offset Printing, Color Printing, Digital Printing, Print Management, Print On Demand, Copy Editing, Collateral Materials..., Product Marketing, Corporate Branding, Packaging, POP Displays, Retail Displays, Display Advertising, Exhibit Design, Advertising Management, Direct Marketing, Small Business, Account Management, Project Management, Communication Skills, Problem Solving, Organization &..., Highly detail oriented, Fast Learner, Team-oriented, Self-starter, Work Well Independently, High level of initiative, Courteous demeanor, Energetic work attitude, Strong work ethic, Adobe Design Premium..., Adobe Acrobat Pro, QuarkXPress 9, Stuffit Deluxe 10.0, Microsoft Office 2010, Web Design (HTML, CSS,..., AutoCAD 2012, Dreamweaver, Graphics, OS X, Pre-press, Layout, Adobe Acrobat, AutoCAD, Image Editing, Brochures
Education
California College of the Arts
Bachelor of Arts (B.A.), Advertising and Communications / GED (minor)
San Joaquin Delta College
Associate of Arts (A.A.), Advertising Art / Music (minor)
Adecco Technical Staffing May 2015 - Present
Graphic Communicators January 2002 - Present
Maetrics, LLC February 2014 - April 2015
Thermo Fisher Scientific 2015 - 2015
Thermo Fisher Scientific 2015 - 2015
Thermo Fisher Scientific 2015 - 2015
Thermo Fisher Scientific 2015 - 2015
MAETRICS 2014 - 2015
MAETRICS 2014 - 2015
MAETRICS 2014 - 2015
Skills
PC Computer, Mac OS X, Graphic Design, Offset Printing, Color Printing, Digital Printing, Print Management, Print On Demand, Copy Editing, Collateral Materials..., Product Marketing, Corporate Branding, Packaging, POP Displays, Retail Displays, Display Advertising, Exhibit Design, Advertising Management, Direct Marketing, Small Business, Account Management, Project Management, Communication Skills, Problem Solving, Organization &..., Highly detail oriented, Fast Learner, Team-oriented, Self-starter, Work Well Independently, High level of initiative, Courteous demeanor, Energetic work attitude, Strong work ethic, Adobe Design Premium..., Adobe Acrobat Pro, QuarkXPress 9, Stuffit Deluxe 10.0, Microsoft Office 2010, Web Design (HTML, CSS,..., AutoCAD 2012, Dreamweaver, Graphics, OS X, Pre-press, Layout, Adobe Acrobat, AutoCAD, Image Editing, Brochures
Education
California College of the Arts
Bachelor of Arts (B.A.), Advertising and Communications / GED (minor)
San Joaquin Delta College
Associate of Arts (A.A.), Advertising Art / Music (minor)
Tina Tank RN CCRP's Maetrics, LLC Experience December 2014 - Present
Job Quality Analyst/MDR Specialist at MAETRICS LLC
Industry Medical Devices
Experience
MAETRICS LLC December 2014 - Present
Allergan June 2008 - November 2014
Lompoc Hospital January 1999 - June 2008
Valley Medical Group May 2003 - May 2008
Skills
Oncology, Neurology, Cardiology, Psychiatry, Diabetes, Clinical Trials, Pediatrics, Surgery, Critical Care, Medical/Surgical, Medical-Surgical, Pharmaceutical Industry, Pharmacovigilance, Medical Devices, Nursing, Healthcare, GCP, FDA
Education
Kaplan University-Hagerstown Campus 2012 — 2014
Bachelor of Applied Science (B.A.Sc.), Registered Nursing, Nursing Administration, Nursing Research and Clinical Nursing
Alan Hancock College
Associate of Science (A.S.), Registered Nursing/Registered Nurse
MAETRICS LLC December 2014 - Present
Allergan June 2008 - November 2014
Lompoc Hospital January 1999 - June 2008
Valley Medical Group May 2003 - May 2008
Skills
Oncology, Neurology, Cardiology, Psychiatry, Diabetes, Clinical Trials, Pediatrics, Surgery, Critical Care, Medical/Surgical, Medical-Surgical, Pharmaceutical Industry, Pharmacovigilance, Medical Devices, Nursing, Healthcare, GCP, FDA
Education
Kaplan University-Hagerstown Campus 2012 — 2014
Bachelor of Applied Science (B.A.Sc.), Registered Nursing, Nursing Administration, Nursing Research and Clinical Nursing
Alan Hancock College
Associate of Science (A.S.), Registered Nursing/Registered Nurse
Steve Garza's Maetrics, LLC Experience December 2008 - December 2010
Job Validation Engineer w/Black Diamond Networks
Industry Medical Devices
Experience
Black Diamond Networks 2011 - Present
Maetrics, LLC December 2008 - December 2010
Boston Scientific 2006 - 2008
Skills
Project Management, Regulatory Affairs, Lean Manufacturing, Medical Devices, Validation, Quality System, FDA, ISO 13485, Testing, R&D, Design Control, Minitab, Software Documentation, GMP, CAPA, Quality Assurance, Process Improvement, DMAIC, Engineering, Process Simulation, Supplier Quality, V&V, Six Sigma, Quality Auditing, Sop, Change Control, Quality Control, Risk Management, 21 CFR Part 11, GxP, Root Cause Analysis, Pharmaceutical Industry, Recruiting, Quality Management, Design of Experiments, Auditing, Microsoft Excel, Product Development, ISO, Process Engineering, Computer System..., Complaint Management, Risk Assessment, Manufacturing, Regulatory Requirements, FMEA, SPC, Microsoft Office, Biopharmaceuticals, Biotechnology
Education
The University of Texas at San Antonio
Bachelor's degree, Business, Management, Marketing, and Related Support Services
Black Diamond Networks 2011 - Present
Maetrics, LLC December 2008 - December 2010
Boston Scientific 2006 - 2008
Skills
Project Management, Regulatory Affairs, Lean Manufacturing, Medical Devices, Validation, Quality System, FDA, ISO 13485, Testing, R&D, Design Control, Minitab, Software Documentation, GMP, CAPA, Quality Assurance, Process Improvement, DMAIC, Engineering, Process Simulation, Supplier Quality, V&V, Six Sigma, Quality Auditing, Sop, Change Control, Quality Control, Risk Management, 21 CFR Part 11, GxP, Root Cause Analysis, Pharmaceutical Industry, Recruiting, Quality Management, Design of Experiments, Auditing, Microsoft Excel, Product Development, ISO, Process Engineering, Computer System..., Complaint Management, Risk Assessment, Manufacturing, Regulatory Requirements, FMEA, SPC, Microsoft Office, Biopharmaceuticals, Biotechnology
Education
The University of Texas at San Antonio
Bachelor's degree, Business, Management, Marketing, and Related Support Services
Afra Anane's Maetrics, LLC Experience November 2013 - Present
Job Complaint Specialist III at DePuy Synthes Power Tools
Industry Medical Devices
Experience
DePuy Synthes (Johnson & Johnson) April 2014 - Present
Maetrics LLC November 2013 - Present
MAETRICS 2013 - 2014
Community Blood Centers of Florida, Inc. January 2012 - July 2013
Ortho Clinical Diagnostics March 2005 - January 2010
ortho clincal disgnostics March 2004 - December 2005
Ortho Clinical Diagnostics June 1998 - March 2004
Ortho-Clinical Diagnostics Company -Johnson & Johnson. October 1996 - March 2004
Skills
FDA, Design Control, V&V, Regulatory Affairs, Change Control, Complaint Management, Pharmaceutical Industry, Process Improvement, Microbiology, SOP, ISO
Education
Kean University 1990 — 1994
•Bachelor of Science, Medical Technology
Raritan Valley Community College 1988 — 1990
•Associate of Science, Biology
DePuy Synthes (Johnson & Johnson) April 2014 - Present
Maetrics LLC November 2013 - Present
MAETRICS 2013 - 2014
Community Blood Centers of Florida, Inc. January 2012 - July 2013
Ortho Clinical Diagnostics March 2005 - January 2010
ortho clincal disgnostics March 2004 - December 2005
Ortho Clinical Diagnostics June 1998 - March 2004
Ortho-Clinical Diagnostics Company -Johnson & Johnson. October 1996 - March 2004
Skills
FDA, Design Control, V&V, Regulatory Affairs, Change Control, Complaint Management, Pharmaceutical Industry, Process Improvement, Microbiology, SOP, ISO
Education
Kean University 1990 — 1994
•Bachelor of Science, Medical Technology
Raritan Valley Community College 1988 — 1990
•Associate of Science, Biology
Debara Reese's Maetrics, LLC Experience March 2013 - August 2014
Job Consumer Safety Officer at FDA
Industry Medical Devices
Experience
FDA September 2014 - Present
Maetrics, LLC March 2013 - August 2014
Zimmer June 2008 - March 2013
Maetrics, LLC March 2007 - June 2008
Roche Diagnostics November 1982 - March 2007
Roche Diagnostics 1998 - 2007
Boehringer Mannheim 1990 - 1997
Skills
Trained Lead Assessor, Passed RAC in 1993, CAPA, FDA, ISO 13485, V&V, Quality System, Design Control, Validation, Medical Devices, GMP, Regulatory Affairs, 21 CFR Part 11, Quality Auditing, Sop, Change Control, ISO 14971, Quality Assurance, 21 CFR, Auditing, CE marking, FDA GMP, GxP, SOP, V
Education
Purdue University 1977 — 1981
Bachelor of Science, Microbiology
FDA September 2014 - Present
Maetrics, LLC March 2013 - August 2014
Zimmer June 2008 - March 2013
Maetrics, LLC March 2007 - June 2008
Roche Diagnostics November 1982 - March 2007
Roche Diagnostics 1998 - 2007
Boehringer Mannheim 1990 - 1997
Skills
Trained Lead Assessor, Passed RAC in 1993, CAPA, FDA, ISO 13485, V&V, Quality System, Design Control, Validation, Medical Devices, GMP, Regulatory Affairs, 21 CFR Part 11, Quality Auditing, Sop, Change Control, ISO 14971, Quality Assurance, 21 CFR, Auditing, CE marking, FDA GMP, GxP, SOP, V
Education
Purdue University 1977 — 1981
Bachelor of Science, Microbiology
Robert Minchow's Maetrics, LLC Experience June 2010 - Present
Job Biotechnology/Medical Device Professional
Industry Medical Devices
Experience
Maetrics, LLC June 2010 - Present
Stryker Endoscopy June 2010 - Present
Elanco September 2007 - April 2009
Lonza September 2005 - May 2006
Norgine 2004 - 2005
Monsanto 2000 - 2003
Lifecore Biomedical 1997 - 2000
Genzyme 1992 - 1996
Skills
Computer System..., 21 CFR Part 11, Change Control, Validation, cGMP
Education
Colorado State University
Mathematics
University of Minnesota-Twin Cities
BA, Statistics
Maetrics, LLC June 2010 - Present
Stryker Endoscopy June 2010 - Present
Elanco September 2007 - April 2009
Lonza September 2005 - May 2006
Norgine 2004 - 2005
Monsanto 2000 - 2003
Lifecore Biomedical 1997 - 2000
Genzyme 1992 - 1996
Skills
Computer System..., 21 CFR Part 11, Change Control, Validation, cGMP
Education
Colorado State University
Mathematics
University of Minnesota-Twin Cities
BA, Statistics
Minny Chang, RN BSN's Maetrics, LLC Experience June 2013 - August 2013
Job Subject Matter Expert in Drug Safety and Medical Device
Industry Medical Devices
Experience
QualityHub, Inc. November 2014 - Present
Validant August 2013 - September 2015
Maetrics, LLC June 2013 - August 2013
International Services, LLC September 2012 - May 2013
UCB Pharma March 2011 - September 2012
Quintiles December 2010 - March 2011
Biogen Idec November 2006 - October 2010
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2006 - August 2006
Novartis April 2005 - April 2006
PFIZER PHARMACEUTICALS (K-force Agency) May 2004 - April 2005
Skills
Clinical Research, Training, Oncology, Vendor Management, Biotechnology, Clinical Trials, ICH-GCP, Healthcare, Regulatory Affairs, Pharmacovigilance, CRO, Sop, FDA, Medical Devices, Software Documentation, Quality Assurance, Pharmaceutical Industry, SOP, Clinical Development, GCP, Life Sciences, Regulatory Submissions, CTMS, Cross-functional Team..., Cardiology, Neurology, Drug Development, Infectious Diseases, Medical Affairs, Pharmaceutics
Education
Rutgers, The State University of New Jersey-Newark 1990 — 1994
BSN, Nursing
Cedar Ridge High School
QualityHub, Inc. November 2014 - Present
Validant August 2013 - September 2015
Maetrics, LLC June 2013 - August 2013
International Services, LLC September 2012 - May 2013
UCB Pharma March 2011 - September 2012
Quintiles December 2010 - March 2011
Biogen Idec November 2006 - October 2010
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2006 - August 2006
Novartis April 2005 - April 2006
PFIZER PHARMACEUTICALS (K-force Agency) May 2004 - April 2005
Skills
Clinical Research, Training, Oncology, Vendor Management, Biotechnology, Clinical Trials, ICH-GCP, Healthcare, Regulatory Affairs, Pharmacovigilance, CRO, Sop, FDA, Medical Devices, Software Documentation, Quality Assurance, Pharmaceutical Industry, SOP, Clinical Development, GCP, Life Sciences, Regulatory Submissions, CTMS, Cross-functional Team..., Cardiology, Neurology, Drug Development, Infectious Diseases, Medical Affairs, Pharmaceutics
Education
Rutgers, The State University of New Jersey-Newark 1990 — 1994
BSN, Nursing
Cedar Ridge High School
Nadia Greenidge's Maetrics, LLC Experience 2012 - 2012
Job Sr. Regulatory Associate at Biotest Pharmaceuticals Corporation
Industry Medical Devices
Experience
Biotest Pharmaceuticals Corporation November 2012 - Present
Consulting - Medical Device Quality Assurance January 2012 - Present
United Artist Group 2014 - 2015
United Artist Group 2014 - 2015
United Artist Group 2014 - 2015
Dexcom January 2010 - January 2012
Maetrics, LLC 2012 - 2012
Cell Science Systems 2007 - 2010
Skills
ISO 13485, GMP, Medical Devices, FDA, Regulatory Submissions, Quality System, CAPA, Validation, Sop, Pharmaceutical Industry, Lifesciences, Management, Quality Assurance, V&V, Design Control, ISO 14971, Regulatory Affairs, Quality Auditing, Change Control, Quality Control, Technology Transfer, CE marking, 21 CFR Part 11, SOP, Life Sciences
Education
Nova Southeastern University 2007 — 2011
EDD, Organizational Leadership & HR
New York University 1981 — 1994
MS and M.Phil degrees, Anthropology and Biomechanics, A
Rutgers University-New Brunswick 1977 — 1981
Bachelor's Degree, Anthropology and Biology, B+
Biotest Pharmaceuticals Corporation November 2012 - Present
Consulting - Medical Device Quality Assurance January 2012 - Present
United Artist Group 2014 - 2015
United Artist Group 2014 - 2015
United Artist Group 2014 - 2015
Dexcom January 2010 - January 2012
Maetrics, LLC 2012 - 2012
Cell Science Systems 2007 - 2010
Skills
ISO 13485, GMP, Medical Devices, FDA, Regulatory Submissions, Quality System, CAPA, Validation, Sop, Pharmaceutical Industry, Lifesciences, Management, Quality Assurance, V&V, Design Control, ISO 14971, Regulatory Affairs, Quality Auditing, Change Control, Quality Control, Technology Transfer, CE marking, 21 CFR Part 11, SOP, Life Sciences
Education
Nova Southeastern University 2007 — 2011
EDD, Organizational Leadership & HR
New York University 1981 — 1994
MS and M.Phil degrees, Anthropology and Biomechanics, A
Rutgers University-New Brunswick 1977 — 1981
Bachelor's Degree, Anthropology and Biology, B+
ED AKPAITA's Maetrics, LLC Experience July 2013 - January 2014
Job Div. Vice President, Quality at Pharmavite LLC
Industry Pharmaceuticals
Experience
Pharmavite LLC January 2014 - Present
Maetrics LLC July 2013 - January 2014
AKP PHARM Consulting Services,Inc. January 2012 - January 2013
The Quantic Group April 2012 - October 2012
Cephalon, Inc August 2002 - August 2010
Skills
Pharmaceutical Industry, CAPA, Quality System, Risk Management, Manufacturing, GMP, FDA, Validation, 21 CFR Part 11, GxP, Regulatory Affairs, Sop, V&V, Change Control, Biopharmaceuticals, Regulatory Submissions, GLP, Auditing, Regulatory Requirements
Education
Western Carolina University 1984 — 1986
BS, MBA, Chemistry, Business Administration
Shaw University 1976 — 1980
Bachelor of Science (BS), Chemistry
Pharmavite LLC January 2014 - Present
Maetrics LLC July 2013 - January 2014
AKP PHARM Consulting Services,Inc. January 2012 - January 2013
The Quantic Group April 2012 - October 2012
Cephalon, Inc August 2002 - August 2010
Skills
Pharmaceutical Industry, CAPA, Quality System, Risk Management, Manufacturing, GMP, FDA, Validation, 21 CFR Part 11, GxP, Regulatory Affairs, Sop, V&V, Change Control, Biopharmaceuticals, Regulatory Submissions, GLP, Auditing, Regulatory Requirements
Education
Western Carolina University 1984 — 1986
BS, MBA, Chemistry, Business Administration
Shaw University 1976 — 1980
Bachelor of Science (BS), Chemistry
Denise (Whitehead) Arrington's Maetrics, LLC Experience September 2013 - Present
Job Sr. Quality & Regulatory Specialist
Industry Medical Devices
Experience
Maetrics, LLC September 2013 - Present
YOH/ Beckman Coulter July 2013 - September 2013
Indpendent Regulatory Consultant May 2013 - July 2013
Humphrey Regulatory Consulting, Inc. April 2011 - May 2013
Helath-Chem Diagnostics December 2008 - April 2011
Neuro Resource Group September 2005 - December 2008
Advanced Neuromodulation Systems 1995 - 2002
Skills
Medical Devices, ISO 13485, FDA, Design Control, Product Launch, Validation, Quality System, R&D, GMP, Regulatory Affairs, CAPA, Product Development, Cross-functional Team..., Microsoft Office, CE marking, Dietary Supplements, Quality Assurance, Quality Auditing, Regulatory Submissions, ISO, Quality Control, Regulatory Requirements, Sop, Manufacturing, SOP, GLP, V&V, 21 CFR, 21 CFR Part 11, Biotechnology, Quality Management
Education
American InterContinental University 2006 — 2008
Bachelor of Applied Science (BASc)
American InterContinental University 2002 — 2004
Associate of Arts (A.A.)
Collin County Community College 2000 — 2002
Associate of Arts and Sciences (A.A.S.)
Maetrics, LLC September 2013 - Present
YOH/ Beckman Coulter July 2013 - September 2013
Indpendent Regulatory Consultant May 2013 - July 2013
Humphrey Regulatory Consulting, Inc. April 2011 - May 2013
Helath-Chem Diagnostics December 2008 - April 2011
Neuro Resource Group September 2005 - December 2008
Advanced Neuromodulation Systems 1995 - 2002
Skills
Medical Devices, ISO 13485, FDA, Design Control, Product Launch, Validation, Quality System, R&D, GMP, Regulatory Affairs, CAPA, Product Development, Cross-functional Team..., Microsoft Office, CE marking, Dietary Supplements, Quality Assurance, Quality Auditing, Regulatory Submissions, ISO, Quality Control, Regulatory Requirements, Sop, Manufacturing, SOP, GLP, V&V, 21 CFR, 21 CFR Part 11, Biotechnology, Quality Management
Education
American InterContinental University 2006 — 2008
Bachelor of Applied Science (BASc)
American InterContinental University 2002 — 2004
Associate of Arts (A.A.)
Collin County Community College 2000 — 2002
Associate of Arts and Sciences (A.A.S.)
Jovan Bonds's Maetrics, LLC Experience August 2013 - Present
Job Senior Consultant at Regulatory and Quality Solutions LLC (R&Q)
Industry Medical Devices
Experience
Regulatory and Quality Solutions LLC (R&Q) October 2014 - Present
Maetrics, LLC August 2013 - Present
Roche Diagnostics January 2008 - August 2013
Roche Diagnostics May 2006 - January 2008
Disetronic Medical Systems January 2004 - May 2006
Roche Diagnostics December 2002 - January 2004
Indiana Department of Workforce Development May 1997 - December 2002
Skills
Medical Devices, Diabetes, FDA, Training, SAP, Pharmaceutical Industry, 21 CFR Part 11, CAPA, Customer Service, GMP, Management, Cross-functional Team..., Computer System..., Biotechnology, Microsoft Excel, Regulatory Affairs, Human Resources, Validation, Troubleshooting, Software Documentation, Hardware Diagnostics, Microsoft Word, Complaince, Diabetes Care, Coagulation, Technical Writing, Compass, Quality Consulting, MDRs, Privacy Policies, Privacy Compliance, Privacy Regulations, Privacy Act, Data Privacy, Security Management, Supplemental MDRs, Remediation, Process Improvement, EtQ Reliance
Education
Franklin College 1999 — 2002
B.A., Political Science, Psychology and Law, 3.0 GPA
Vincennes University 1996 — 1999
Pre-Law
Regulatory and Quality Solutions LLC (R&Q) October 2014 - Present
Maetrics, LLC August 2013 - Present
Roche Diagnostics January 2008 - August 2013
Roche Diagnostics May 2006 - January 2008
Disetronic Medical Systems January 2004 - May 2006
Roche Diagnostics December 2002 - January 2004
Indiana Department of Workforce Development May 1997 - December 2002
Skills
Medical Devices, Diabetes, FDA, Training, SAP, Pharmaceutical Industry, 21 CFR Part 11, CAPA, Customer Service, GMP, Management, Cross-functional Team..., Computer System..., Biotechnology, Microsoft Excel, Regulatory Affairs, Human Resources, Validation, Troubleshooting, Software Documentation, Hardware Diagnostics, Microsoft Word, Complaince, Diabetes Care, Coagulation, Technical Writing, Compass, Quality Consulting, MDRs, Privacy Policies, Privacy Compliance, Privacy Regulations, Privacy Act, Data Privacy, Security Management, Supplemental MDRs, Remediation, Process Improvement, EtQ Reliance
Education
Franklin College 1999 — 2002
B.A., Political Science, Psychology and Law, 3.0 GPA
Vincennes University 1996 — 1999
Pre-Law
Tim Bordner's Maetrics, LLC Experience 2006 - 2007
Job Sr. Mfg. Engineer/Process Engineer at Arthrex
Industry Medical Devices
Experience
Arthrex 2008 - Present
Kelly Scientific Resources June 2007 - December 2007
Maetrics, LLC 2006 - 2007
Metaldyne 1997 - 2005
Hutchinson FTS 1994 - 1997
Burr Oak Tool 1991 - 1994
Skills
Medical Devices, Process Improvement, FDA, Solidworks, ISO 13485, Validation
Education
Tri-State University 1989 — 1991
Bachelor of Science (B.S.), Technical Management
Tri-State University 1987 — 1989
Associate of Science (A.S.), Manufacturing Engineering Technology/Technician
Arthrex 2008 - Present
Kelly Scientific Resources June 2007 - December 2007
Maetrics, LLC 2006 - 2007
Metaldyne 1997 - 2005
Hutchinson FTS 1994 - 1997
Burr Oak Tool 1991 - 1994
Skills
Medical Devices, Process Improvement, FDA, Solidworks, ISO 13485, Validation
Education
Tri-State University 1989 — 1991
Bachelor of Science (B.S.), Technical Management
Tri-State University 1987 — 1989
Associate of Science (A.S.), Manufacturing Engineering Technology/Technician
Francis Dobscha's Maetrics, LLC Experience March 2014 - March 2015
Job Consultant, Regulatory Affairs and Quality Assurance
Industry Government Relations
Experience
Independant Business Consultant 2015 - Present
MAETRICS LLC March 2014 - March 2015
Covidien 2007 - 2011
AdvaMed 2005 - 2007
NOMOS Corporation 2000 - 2004
OpusRegs Consulting 1998 - 2000
Respironics 1995 - 1998
Instrumentation Industries, Inc. 1991 - 1995
Medrad 1988 - 1991
Swason Analysis Systems, Inc. (ANSYS, Inc.) 1987 - 1988
Skills
Regulatory Affairs, Regulatory Strategy..., Regulatory Submissions, Regulatory Intelligence, Medical Device Directive, CE marking, Quality System..., Post Market Surveillance, MDR, Adverse Event Reporting, Technical Files, Executive Management, Business Strategy, Business Development, Industry Advocacy, Public Relations, Technical Writing, Public Speaking, Crisis Management, Product Development, Continuous Improvement, Global Regulatory..., Quality System, GMP, Quality Assurance, Clinical Trials, ISO 13485, ISO 14971, FDA, Medical Devices, Design Control, CAPA, V&V, Validation, Cross-functional Team..., Regulatory Requirements, Product Launch, 21 CFR Part 11, Process Improvement, Quality Control, Leadership, Management, Change Control, SOP, Commercialization, Quality Management, ISO, Strategic Planning, Technology Transfer, Root Cause Analysis
Education
University of Pittsburgh - Joseph M. Katz Graduate School of Business 1987 — 1990
Master of Business Administration (MBA), Business Administration and Management, General
Carnegie Mellon University 1979 — 1983
Bachelor of Science (BS), Technical and Scientific Communication
Independant Business Consultant 2015 - Present
MAETRICS LLC March 2014 - March 2015
Covidien 2007 - 2011
AdvaMed 2005 - 2007
NOMOS Corporation 2000 - 2004
OpusRegs Consulting 1998 - 2000
Respironics 1995 - 1998
Instrumentation Industries, Inc. 1991 - 1995
Medrad 1988 - 1991
Swason Analysis Systems, Inc. (ANSYS, Inc.) 1987 - 1988
Skills
Regulatory Affairs, Regulatory Strategy..., Regulatory Submissions, Regulatory Intelligence, Medical Device Directive, CE marking, Quality System..., Post Market Surveillance, MDR, Adverse Event Reporting, Technical Files, Executive Management, Business Strategy, Business Development, Industry Advocacy, Public Relations, Technical Writing, Public Speaking, Crisis Management, Product Development, Continuous Improvement, Global Regulatory..., Quality System, GMP, Quality Assurance, Clinical Trials, ISO 13485, ISO 14971, FDA, Medical Devices, Design Control, CAPA, V&V, Validation, Cross-functional Team..., Regulatory Requirements, Product Launch, 21 CFR Part 11, Process Improvement, Quality Control, Leadership, Management, Change Control, SOP, Commercialization, Quality Management, ISO, Strategic Planning, Technology Transfer, Root Cause Analysis
Education
University of Pittsburgh - Joseph M. Katz Graduate School of Business 1987 — 1990
Master of Business Administration (MBA), Business Administration and Management, General
Carnegie Mellon University 1979 — 1983
Bachelor of Science (BS), Technical and Scientific Communication
Robert Pagano's Maetrics, LLC Experience May 2013 - Present
Job Sr. Compliance and Quality Consultant at Maetrics, LLC
Industry Management Consulting
Experience
Maetrics, LLC May 2013 - Present
SCC Soft Computer November 2005 - April 2013
Eckerd 1996 - 2005
Skills
Quality Assurance, Compliance, Auditing, 21 CFR Part 11, CAPA, GMP, ISO, Manufacturing, Process Improvement, Quality Auditing, Quality Control, Quality Management, Quality System, Software Documentation, Validation, Visio
Education
Mattatuck College 1985 — 1987
Associate's degree, Business Management
Central Connecticut State University 1983 — 1985
none
Maetrics, LLC May 2013 - Present
SCC Soft Computer November 2005 - April 2013
Eckerd 1996 - 2005
Skills
Quality Assurance, Compliance, Auditing, 21 CFR Part 11, CAPA, GMP, ISO, Manufacturing, Process Improvement, Quality Auditing, Quality Control, Quality Management, Quality System, Software Documentation, Validation, Visio
Education
Mattatuck College 1985 — 1987
Associate's degree, Business Management
Central Connecticut State University 1983 — 1985
none
Joe Marsala's Maetrics, LLC Experience August 2014 - December 2014
Job Sr. Quality Engineer
Industry Medical Devices
Experience
Maetrics LLC August 2014 - December 2014
Industrial Services June 2013 - September 2013
Pride Mobility Products Corporation February 2009 - March 2013
Pride Mobility Products Corporation March 2003 - February 2009
Skills
Quality System, Manufacturing, Quality Auditing, Medical Devices, 21 CFR 820 GMP, 21 CFR Part 11 GDP, Medical Mobile Devices, CAPA Validation, Supplier Quality, First Time Quality..., Original Equipment..., Standard Operation..., Rework Procedures, Prototype Validation, First Article Inspection, CMM Product Inspection..., Process Capability, Geometric Dimensioning..., Welding Inspection, Calibration Techniques, ASTM standards, Material..., Pantone Standards, Bill of Materials..., Material Review Board, Non-Comforming Review, ISO 9001, ISO 13485, Proficient in Microsoft..., Validation, CAPA, Process Improvement, FDA, Quality Assurance, Testing, GMP, Project Management, ISO, Training, Quality System..., Materials, Machining, Continuous Improvement, Change Control, Quality Control, Documentation, Product Development, Lean Manufacturing, Microsoft Office, SAP
Education
Muskegon Community College
Geometric Dimensioning & Tolerance, Basic AutoCAD, 3D Advanced AutoCAD, Customizing AutoCAD
Grand Haven Michigan Aduit Education (US Department of Labor)
US Department of Labor Bureau of Apprenticeship and Training, Precision Tool & Cutter Grinder, Certification
Muskegon Community College
Air Conditioning & Refrigeration
Maetrics LLC August 2014 - December 2014
Industrial Services June 2013 - September 2013
Pride Mobility Products Corporation February 2009 - March 2013
Pride Mobility Products Corporation March 2003 - February 2009
Skills
Quality System, Manufacturing, Quality Auditing, Medical Devices, 21 CFR 820 GMP, 21 CFR Part 11 GDP, Medical Mobile Devices, CAPA Validation, Supplier Quality, First Time Quality..., Original Equipment..., Standard Operation..., Rework Procedures, Prototype Validation, First Article Inspection, CMM Product Inspection..., Process Capability, Geometric Dimensioning..., Welding Inspection, Calibration Techniques, ASTM standards, Material..., Pantone Standards, Bill of Materials..., Material Review Board, Non-Comforming Review, ISO 9001, ISO 13485, Proficient in Microsoft..., Validation, CAPA, Process Improvement, FDA, Quality Assurance, Testing, GMP, Project Management, ISO, Training, Quality System..., Materials, Machining, Continuous Improvement, Change Control, Quality Control, Documentation, Product Development, Lean Manufacturing, Microsoft Office, SAP
Education
Muskegon Community College
Geometric Dimensioning & Tolerance, Basic AutoCAD, 3D Advanced AutoCAD, Customizing AutoCAD
Grand Haven Michigan Aduit Education (US Department of Labor)
US Department of Labor Bureau of Apprenticeship and Training, Precision Tool & Cutter Grinder, Certification
Muskegon Community College
Air Conditioning & Refrigeration
Deloitte
PwC
Ernst & Young
Walgreens
Procter & Gamble
KPMG
PricewaterhouseCoopers
EY