MAETRICS Company
Industry: Company
DescriptionFounded: 1984 Subsidiary: Maetrics Ltd.
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MAETRICS Employees
Employee
Years
Job
Industry
Nancy Watters Nancy Watters's MAETRICS Experience October 2014 - January 2015
Job Quality Assurance and Compliance Consultant
Industry Information Technology and Services
Experience
Progilisys Solutions January 2015 - Present
MAETRICS October 2014 - January 2015
MAETRICS May 2013 - May 2014
Oxford Global Resources December 2012 - March 2013
Hiwasse Manufacturing Company August 2009 - November 2011
Octapharma Plasma, Inc. March 2010 - June 2011
Gyrus ACMI/ENT Division July 2006 - May 2008
BD May 2001 - July 2006
Skills
Quality System, Quality Assurance, FDA, Software Documentation, Six Sigma, CAPA, ISO, Lean Manufacturing, Manufacturing, Process Improvement, Sop, Technical Writing, Quality Control, Kaizen, Change Control, 5S, SAP, 21 CFR Part 11, Training, Iso 9000, ISO 13485, Medical Devices, Document Management, FDA GMP, Supply Chain, Minitab, Design Control, Quality Auditing, Regulatory Affairs, DMAIC, Design for Manufacturing, GMP, Validation, SOP
Education
Davis Applied Technology College 1982 — 1984
Machine Tool Technology/Machinist
Salt Lake Community College 1971 — 1972
Psycology
Progilisys Solutions January 2015 - Present
MAETRICS October 2014 - January 2015
MAETRICS May 2013 - May 2014
Oxford Global Resources December 2012 - March 2013
Hiwasse Manufacturing Company August 2009 - November 2011
Octapharma Plasma, Inc. March 2010 - June 2011
Gyrus ACMI/ENT Division July 2006 - May 2008
BD May 2001 - July 2006
Skills
Quality System, Quality Assurance, FDA, Software Documentation, Six Sigma, CAPA, ISO, Lean Manufacturing, Manufacturing, Process Improvement, Sop, Technical Writing, Quality Control, Kaizen, Change Control, 5S, SAP, 21 CFR Part 11, Training, Iso 9000, ISO 13485, Medical Devices, Document Management, FDA GMP, Supply Chain, Minitab, Design Control, Quality Auditing, Regulatory Affairs, DMAIC, Design for Manufacturing, GMP, Validation, SOP
Education
Davis Applied Technology College 1982 — 1984
Machine Tool Technology/Machinist
Salt Lake Community College 1971 — 1972
Psycology
Andrew Levitsky Andrew Levitsky's MAETRICS Experience July 2014 - Present
Job Clinical Trial Assistant at Ethicon
Industry Biotechnology
Experience
Acro Service Corp February 2015 - Present
MAETRICS July 2014 - Present
St. George's Pathfinders of America July 2007 - Present
Ethicon July 2013 - May 2014
Vector Marketing June 2008 - July 2009
East Brunswick Rescue Squad 2007 - 2008
Skills
Biotechnology, Lifesciences, Biomedical Engineering, Pro-Engineer, Labview, ANSYS, Drafting, Biopac, Mimics, Pro Engineer, Leadership, Mathematica, Pspice, Technical Writing, Microsoft Office, Data Analysis, Matlab, Life Sciences, LabVIEW, Legal Writing, FDA
Education
The College of New Jersey 2008 — 2012
Bachelor of Science (B.S.), Biomedical/Medical Engineering
Acro Service Corp February 2015 - Present
MAETRICS July 2014 - Present
St. George's Pathfinders of America July 2007 - Present
Ethicon July 2013 - May 2014
Vector Marketing June 2008 - July 2009
East Brunswick Rescue Squad 2007 - 2008
Skills
Biotechnology, Lifesciences, Biomedical Engineering, Pro-Engineer, Labview, ANSYS, Drafting, Biopac, Mimics, Pro Engineer, Leadership, Mathematica, Pspice, Technical Writing, Microsoft Office, Data Analysis, Matlab, Life Sciences, LabVIEW, Legal Writing, FDA
Education
The College of New Jersey 2008 — 2012
Bachelor of Science (B.S.), Biomedical/Medical Engineering
Christopher Barnette Christopher Barnette's MAETRICS Experience April 2013 - January 2015
Job PostMarket Auditor at EG Life Sciences
Industry Hospital & Health Care
Experience
EG Life Sciences July 2015 - Present
ALKU January 2015 - July 2015
MAETRICS April 2013 - January 2015
Baxter International Inc. November 2007 - March 2013
Skills
GMP, Medical Devices, FDA, Quality Assurance, Quality System, SOP, 21 CFR Part 11, Pharmaceutical Industry, V, ISO 13485, Process Improvement, Quality Control
Education
Le Cordon Bleu College of Culinary Arts-Chicago 2005 — 2006
Culinary Arts/Chef Training
EG Life Sciences July 2015 - Present
ALKU January 2015 - July 2015
MAETRICS April 2013 - January 2015
Baxter International Inc. November 2007 - March 2013
Skills
GMP, Medical Devices, FDA, Quality Assurance, Quality System, SOP, 21 CFR Part 11, Pharmaceutical Industry, V, ISO 13485, Process Improvement, Quality Control
Education
Le Cordon Bleu College of Culinary Arts-Chicago 2005 — 2006
Culinary Arts/Chef Training
Diane Gorman Diane Gorman's MAETRICS Experience September 2012 - Present
Job Solutions Delivery Manager at Maetrics
Industry Medical Devices
Experience
MAETRICS September 2012 - Present
Henry Schein June 2008 - March 2012
Popper and Sons May 1997 - June 2008
Sperry (Lockheed Martin) November 1977 - November 1995
Skills
Surgical Instruments, Medical Devices, Purchasing, Inventory Management, Outlook, Microsoft Excel, Negotiation, Microsoft Office, Microsoft Word, Inventory Control, PowerPoint, Materials Management, JD Edwards, ISO 13485, Part 820, Quality Assurance, CAPA, Quality System, FDA, Sop, Process Improvement, GMP, SOP, Quality Auditing, Quality Management
Education
Ohio University 1972 — 1974
BSEd, Special Education
Nassau Community College 1969 — 1972
MAETRICS September 2012 - Present
Henry Schein June 2008 - March 2012
Popper and Sons May 1997 - June 2008
Sperry (Lockheed Martin) November 1977 - November 1995
Skills
Surgical Instruments, Medical Devices, Purchasing, Inventory Management, Outlook, Microsoft Excel, Negotiation, Microsoft Office, Microsoft Word, Inventory Control, PowerPoint, Materials Management, JD Edwards, ISO 13485, Part 820, Quality Assurance, CAPA, Quality System, FDA, Sop, Process Improvement, GMP, SOP, Quality Auditing, Quality Management
Education
Ohio University 1972 — 1974
BSEd, Special Education
Nassau Community College 1969 — 1972
Dwai Smith Dwai Smith's MAETRICS Experience June 2014 - Present
Job General Manager & VP of Sales at MAETRICS
Industry Research
Experience
MAETRICS June 2014 - Present
Thermo Fisher Scientific July 2012 - June 2014
VWR International January 2007 - July 2012
VWR International April 1996 - December 2006
Skills
Molecular Biology, Biotechnology, PCR, Mass Spectrometry, Chromatography, HPLC, Spectroscopy, Project Management, Sales, Sales Management, Key Account Development, Cross-functional Team..., Strategy, Key Account Management, Supply Chain Management, Sales Operations, Sales Process, P&L Management, Pricing, Customer Satisfaction, Direct Sales, Account Management, Product Launch, Medical Devices, Management, New Business Development, Life Sciences, Contract Negotiation
Education
UCSD 1992 — 1995
Bachelor of Science (B.S.), Biochemistry & Cellular Biology
MAETRICS June 2014 - Present
Thermo Fisher Scientific July 2012 - June 2014
VWR International January 2007 - July 2012
VWR International April 1996 - December 2006
Skills
Molecular Biology, Biotechnology, PCR, Mass Spectrometry, Chromatography, HPLC, Spectroscopy, Project Management, Sales, Sales Management, Key Account Development, Cross-functional Team..., Strategy, Key Account Management, Supply Chain Management, Sales Operations, Sales Process, P&L Management, Pricing, Customer Satisfaction, Direct Sales, Account Management, Product Launch, Medical Devices, Management, New Business Development, Life Sciences, Contract Negotiation
Education
UCSD 1992 — 1995
Bachelor of Science (B.S.), Biochemistry & Cellular Biology
Priscila Mota Priscila Mota's MAETRICS Experience September 2012 - May 2013
Job Principal Post Market Surveillance Specialist at Fresenius Medical Care
Industry Medical Devices
Experience
Fresenius Medical Care January 2015 - Present
Philips May 2013 - January 2015
MAETRICS September 2012 - May 2013
Picis, a part of OptumInsight August 2011 - August 2012
Boston Scientific August 2009 - August 2011
Validant Consulting March 2009 - August 2009
Cordis, a Johnson and Johnson company May 2003 - July 2007
FPL 1998 - 2003
Skills
FDA, ISO 13485, Medical Devices, Quality System, CAPA, Quality Assurance, Complaint Management, Regulatory Affairs, GMP, Process Improvement, Quality Management, Cross-functional Team..., Sop, 21 CFR Part 11, Continuous Improvement, Iso 9000, Design Control, Risk Management, Root Cause Analysis, Regulatory Requirements, Training, ISO 14971, FMEA, Quality Auditing, ISO
Education
Miami Dade College
Associate of Arts (A.A.)
Fresenius Medical Care January 2015 - Present
Philips May 2013 - January 2015
MAETRICS September 2012 - May 2013
Picis, a part of OptumInsight August 2011 - August 2012
Boston Scientific August 2009 - August 2011
Validant Consulting March 2009 - August 2009
Cordis, a Johnson and Johnson company May 2003 - July 2007
FPL 1998 - 2003
Skills
FDA, ISO 13485, Medical Devices, Quality System, CAPA, Quality Assurance, Complaint Management, Regulatory Affairs, GMP, Process Improvement, Quality Management, Cross-functional Team..., Sop, 21 CFR Part 11, Continuous Improvement, Iso 9000, Design Control, Risk Management, Root Cause Analysis, Regulatory Requirements, Training, ISO 14971, FMEA, Quality Auditing, ISO
Education
Miami Dade College
Associate of Arts (A.A.)
Ashley Dickerson Ashley Dickerson's MAETRICS Experience March 2014 - Present
Job Quality Compliance Consultant
Industry Medical Devices
Experience
Black Diamond Consultants 2015 - Present
MAETRICS March 2014 - Present
St. Jude Medical January 2013 - Present
Kroger Manufacturing September 2010 - November 2012
Ventana Medical Systems July 2009 - September 2010
Ventana Medical Systems January 2009 - July 2009
MRI Medical June 2008 - August 2008
Federal Mogul May 2007 - August 2007
Skills
Microsoft Office, Oracle Agile, Business Objects, EMPAC, 5S, Continuous Improvement, Quality Control, Project Management, Supply Chain, Supervising, Recruiting, Customer Satisfaction, FDA, SQF, GMP, OSHA, RCA, Lean Manufacturing, Kaizen, Franklin Covey, Research, Laboratory, Manufacturing, CAPA, Medical Devices, Configuration Management, Data Management, Capital Appropriation, Six Sigma, Management
Education
California State University-Dominguez Hills 2014 — 2016
M.S. Quality Assurance, Manufacturing and Healthcare
University of Arizona 2005 — 2008
Bachelor of Science (BS), Engineering/Industrial Management/CheE
Black Diamond Consultants 2015 - Present
MAETRICS March 2014 - Present
St. Jude Medical January 2013 - Present
Kroger Manufacturing September 2010 - November 2012
Ventana Medical Systems July 2009 - September 2010
Ventana Medical Systems January 2009 - July 2009
MRI Medical June 2008 - August 2008
Federal Mogul May 2007 - August 2007
Skills
Microsoft Office, Oracle Agile, Business Objects, EMPAC, 5S, Continuous Improvement, Quality Control, Project Management, Supply Chain, Supervising, Recruiting, Customer Satisfaction, FDA, SQF, GMP, OSHA, RCA, Lean Manufacturing, Kaizen, Franklin Covey, Research, Laboratory, Manufacturing, CAPA, Medical Devices, Configuration Management, Data Management, Capital Appropriation, Six Sigma, Management
Education
California State University-Dominguez Hills 2014 — 2016
M.S. Quality Assurance, Manufacturing and Healthcare
University of Arizona 2005 — 2008
Bachelor of Science (BS), Engineering/Industrial Management/CheE
Jonathan Stupka Jonathan Stupka's MAETRICS Experience May 2013 - Present
Job Manager at Maetrics, LLC
Industry Medical Devices
Experience
MAETRICS May 2013 - Present
Lakeway Innovations, LLC January 2012 - Present
Amedica Corporation December 2007 - December 2011
On-X Life Technologies May 1994 - November 2007
Carbon Implants, Inc. July 1989 - April 1994
CarboMedics October 1981 - June 1989
Fisher Controls January 1977 - September 1981
Skills
ISO 13485, Medical Devices, FDA, Orthopedics, Product Development, Lean Manufacturing, Quality Systems, Product Design, Solidworks, Start-ups, Capital Equipment, Spine, Design for Manufacturing, Continuous Improvement, Strategic Planning, Design Control, Business Strategy, Engineering, Team Building, Pro/Engineer, CAPA, Problem Solving, Patents, Microsoft Office, Product Launch, FMEA, Validation, Heart Valves, Surgical Instruments, Musical Instruments, Project Management, Project Planning, Department Budgeting, Capital Budgeting, Operations Management, Manufacturing..., Professional Mentoring, Personnel Selection, Personnel Management, Personnel Evaluation, Gantt Project, Return on Investment, Mechanical Engineering, Biomedical Engineering, Manufacturing..., Contract Manufacturing, Process Engineering, Vendor Management, Logistics Management, TQM
Education
University of Minnesota-Twin Cities 1974 — 1976
BS, Mechanical Engineering
Austin Community College, Austin, MN 1972 — 1974
AA, Pre-Engineering
MAETRICS May 2013 - Present
Lakeway Innovations, LLC January 2012 - Present
Amedica Corporation December 2007 - December 2011
On-X Life Technologies May 1994 - November 2007
Carbon Implants, Inc. July 1989 - April 1994
CarboMedics October 1981 - June 1989
Fisher Controls January 1977 - September 1981
Skills
ISO 13485, Medical Devices, FDA, Orthopedics, Product Development, Lean Manufacturing, Quality Systems, Product Design, Solidworks, Start-ups, Capital Equipment, Spine, Design for Manufacturing, Continuous Improvement, Strategic Planning, Design Control, Business Strategy, Engineering, Team Building, Pro/Engineer, CAPA, Problem Solving, Patents, Microsoft Office, Product Launch, FMEA, Validation, Heart Valves, Surgical Instruments, Musical Instruments, Project Management, Project Planning, Department Budgeting, Capital Budgeting, Operations Management, Manufacturing..., Professional Mentoring, Personnel Selection, Personnel Management, Personnel Evaluation, Gantt Project, Return on Investment, Mechanical Engineering, Biomedical Engineering, Manufacturing..., Contract Manufacturing, Process Engineering, Vendor Management, Logistics Management, TQM
Education
University of Minnesota-Twin Cities 1974 — 1976
BS, Mechanical Engineering
Austin Community College, Austin, MN 1972 — 1974
AA, Pre-Engineering
Jill Spencer Jill Spencer's MAETRICS Experience December 2014 - Present
Job Managing Director at MAETRICS
Industry Computer Networking
Experience
MAETRICS December 2014 - Present
IBM April 2013 - October 2014
Cisco Systems April 2010 - April 2013
Accelrys September 2008 - July 2009
Hewlett-Packard November 2007 - August 2008
BearingPoint January 2000 - June 2007
KPMG US January 1998 - December 2000
AG Consulting 1993 - 1999
IVAC Corporation 1982 - 1993
Skills
Management Consulting, Change Management, Project Management, Program Management, Business Process..., Business Analysis, Process Improvement, IT Strategy, Cross-functional Team..., Strategy, Management, Strategic Planning, Business Process, Business Strategy, Business Intelligence, CRM, Enterprise Software, Leadership, Product Management
Education
San Diego State University-California State University
Bachelor of Arts (B.A.), Accounting
MAETRICS December 2014 - Present
IBM April 2013 - October 2014
Cisco Systems April 2010 - April 2013
Accelrys September 2008 - July 2009
Hewlett-Packard November 2007 - August 2008
BearingPoint January 2000 - June 2007
KPMG US January 1998 - December 2000
AG Consulting 1993 - 1999
IVAC Corporation 1982 - 1993
Skills
Management Consulting, Change Management, Project Management, Program Management, Business Process..., Business Analysis, Process Improvement, IT Strategy, Cross-functional Team..., Strategy, Management, Strategic Planning, Business Process, Business Strategy, Business Intelligence, CRM, Enterprise Software, Leadership, Product Management
Education
San Diego State University-California State University
Bachelor of Arts (B.A.), Accounting
David F. Sutton David F. Sutton's MAETRICS Experience March 2013 - January 2015
Job Consultant for Product Development Eng. Design/Eng.Sales Rep/PDERemediation/Compliance & Quality
Industry Medical Devices
Experience
3D-Zine LLC January 2004 - Present
Maetrics March 2013 - January 2015
Symmetry Medical January 2011 - January 2012
DiSanto Technology, Inc. April 2010 - January 2011
Spine Wave, Inc. January 2007 - January 2009
Chimaera, Inc. April 1984 - January 2004
Insight Technologies, LLC May 1997 - October 2000
Skills
Medical Devices, Product Development, Manufacturing, Design Control, R&D, Process Engineering, Engineering, ISO 13485, Manufacturing..., Start-ups, Quality System, Design for Manufacturing, Injection Molding, Kaizen, Solidworks, Product Design, Product Launch, DMAIC, CAD, Continuous Improvement, Entrepreneurship, ISO, Orthopedic, FDA, Value Stream Mapping, Engineering Management, Manufacturing Operations, Validation, Cnc, FMEA, Design of Experiments, Product Management, Process Simulation, Machining, Manufacturing..., Prototyping, Lean Manufacturing, Team Building, New Business Development, Program Management, V&V, CAPA, Six Sigma, Market Development, Cross-functional Team..., Commercialization, Quality Management, Patents, Orthopedics, Leadership
Education
Sacred Heart University
BS, Business Administration, Management and Operations, 3.8
University of Bridgeport
Industrial Design
Norwalk State Tech
Associate of Science (AS), Electromechanical Engineering, 3.6
3D-Zine LLC January 2004 - Present
Maetrics March 2013 - January 2015
Symmetry Medical January 2011 - January 2012
DiSanto Technology, Inc. April 2010 - January 2011
Spine Wave, Inc. January 2007 - January 2009
Chimaera, Inc. April 1984 - January 2004
Insight Technologies, LLC May 1997 - October 2000
Skills
Medical Devices, Product Development, Manufacturing, Design Control, R&D, Process Engineering, Engineering, ISO 13485, Manufacturing..., Start-ups, Quality System, Design for Manufacturing, Injection Molding, Kaizen, Solidworks, Product Design, Product Launch, DMAIC, CAD, Continuous Improvement, Entrepreneurship, ISO, Orthopedic, FDA, Value Stream Mapping, Engineering Management, Manufacturing Operations, Validation, Cnc, FMEA, Design of Experiments, Product Management, Process Simulation, Machining, Manufacturing..., Prototyping, Lean Manufacturing, Team Building, New Business Development, Program Management, V&V, CAPA, Six Sigma, Market Development, Cross-functional Team..., Commercialization, Quality Management, Patents, Orthopedics, Leadership
Education
Sacred Heart University
BS, Business Administration, Management and Operations, 3.8
University of Bridgeport
Industrial Design
Norwalk State Tech
Associate of Science (AS), Electromechanical Engineering, 3.6
Leland (Lee) C. Perry Leland (Lee) C. Perry's MAETRICS Experience 2013 - 2014
Job Current project expected to last until January 2016
Industry Medical Devices
Experience
LCPerry Quality Consultant LLC July 2015 - Present
DePuy Synthes May 2013 - Present
LCP Quality Consulting LLC January 2012 - Present
ETHICON Johnson & Johnson 2015 - 2015
ETHICON Johnson & Johnson 2015 - 2015
Maetrics 2013 - 2014
Novartis Consumer Health September 2012 - April 2013
Large Aseptic Manufacturing Facility January 2012 - April 2012
AVI BioPharma June 2009 - January 2012
Compass-1 Consulting June 2000 - February 2009
Skills
Aseptic Processing, CAPA, Validation, Auditing, Pharmaceutics, V&V, FDA, GMP, Systems, SOP authoring, Medical Devices, Biotechnology Industry, Technical Writing, Cleaning Validation, Quality Assurance, Clinical Development, Sop, Pharmaceutical Industry, Biotechnology, Quality Control, R&D, Change Control, Quality Management, Vaccines, SOP, Microbiology, Quality System, Technology Transfer, Quality Auditing, Regulatory Affairs, 21 CFR Part 11, Life Sciences, Manufacturing, GLP
Education
University of Vermont College of Medicine 1966 — 1968
Medical Microbiology
State University of New York College at Plattsburgh 1963 — 1966
BA
Paul Smith's College 1960 — 1963
AA, Liberal Arts
LCPerry Quality Consultant LLC July 2015 - Present
DePuy Synthes May 2013 - Present
LCP Quality Consulting LLC January 2012 - Present
ETHICON Johnson & Johnson 2015 - 2015
ETHICON Johnson & Johnson 2015 - 2015
Maetrics 2013 - 2014
Novartis Consumer Health September 2012 - April 2013
Large Aseptic Manufacturing Facility January 2012 - April 2012
AVI BioPharma June 2009 - January 2012
Compass-1 Consulting June 2000 - February 2009
Skills
Aseptic Processing, CAPA, Validation, Auditing, Pharmaceutics, V&V, FDA, GMP, Systems, SOP authoring, Medical Devices, Biotechnology Industry, Technical Writing, Cleaning Validation, Quality Assurance, Clinical Development, Sop, Pharmaceutical Industry, Biotechnology, Quality Control, R&D, Change Control, Quality Management, Vaccines, SOP, Microbiology, Quality System, Technology Transfer, Quality Auditing, Regulatory Affairs, 21 CFR Part 11, Life Sciences, Manufacturing, GLP
Education
University of Vermont College of Medicine 1966 — 1968
Medical Microbiology
State University of New York College at Plattsburgh 1963 — 1966
BA
Paul Smith's College 1960 — 1963
AA, Liberal Arts
Gary Chance Gary Chance's MAETRICS Experience August 2013 - May 2014
Job Senior Quality Consultant at NuVasive
Industry Medical Devices
Experience
NuVasive July 2015 - September 2015
EDD November 2014 - June 2015
Asante Solutions June 2014 - November 2014
MAETRICS August 2013 - May 2014
Varian Medical System June 2007 - August 2013
Creative Labs June 2006 - July 2007
Skills
Quality Management, MRB, ISO, Calibration, Quality Systems, ISO 13485, SPC, FDA, CAPA, SOP, Quality Assurance, Six Sigma, Manufacturing, GMP, Process Improvement, Problem Solving, Root Cause Analysis, Engineering, 5S, Auditing, Medical Devices, Inspection, Quality Auditing, Continuous Improvement, Documentation, Quality Inspection, Supplier Quality, Process Validation, Quality Engineering, QSR, Document Management, Supplier Audits, TQM, Lean Manufacturing, ISO 14001, ISO standards, GD&T, Supplier Auditing, Quality System, Validation, Design Control, Quality Control, FMEA, 21 CFR Part 11, ISO 14971, Regulatory Affairs, Iso 9000, ISO 9000
Education
Northwood University 1999 — 2001
Bachelor's, Business Management
Tarrant County College 1995 — 2000
A.A.S, Total Quality Manegement
NuVasive July 2015 - September 2015
EDD November 2014 - June 2015
Asante Solutions June 2014 - November 2014
MAETRICS August 2013 - May 2014
Varian Medical System June 2007 - August 2013
Creative Labs June 2006 - July 2007
Skills
Quality Management, MRB, ISO, Calibration, Quality Systems, ISO 13485, SPC, FDA, CAPA, SOP, Quality Assurance, Six Sigma, Manufacturing, GMP, Process Improvement, Problem Solving, Root Cause Analysis, Engineering, 5S, Auditing, Medical Devices, Inspection, Quality Auditing, Continuous Improvement, Documentation, Quality Inspection, Supplier Quality, Process Validation, Quality Engineering, QSR, Document Management, Supplier Audits, TQM, Lean Manufacturing, ISO 14001, ISO standards, GD&T, Supplier Auditing, Quality System, Validation, Design Control, Quality Control, FMEA, 21 CFR Part 11, ISO 14971, Regulatory Affairs, Iso 9000, ISO 9000
Education
Northwood University 1999 — 2001
Bachelor's, Business Management
Tarrant County College 1995 — 2000
A.A.S, Total Quality Manegement
Braulio Polanco Braulio Polanco's MAETRICS Experience March 2014 - April 2014
Job Senior Program Manager at Nypro, a Jabil Company
Industry Medical Devices
Experience
Nypro, a Jabil Company March 2014 - Present
MAETRICS March 2014 - April 2014
Vention Medical, Inc. November 2012 - January 2014
Terumo Medical March 2011 - November 2012
Teleflex Medical May 2009 - November 2010
Kimberly-Clark February 2006 - May 2009
Kimberly-Clark February 2003 - May 2006
Kimberly-Clark February 1999 - May 2003
Precise Technology Inc June 1998 - September 1998
Tyco Electronics/Madison Cable May 1997 - September 1997
Skills
Materials Science, Polymers, Extrusion, Injection Molding, Rheology, Resin, Thin Films, Fiber, DOE, Design Control, Six Sigma, Minitab, Medical Devices, Medical Device Product..., Process Development, Process Improvement, Process Validation, FDA, Catheters, Photoshop, Photography, Lightroom, DMAIC, Product Development, Design of Experiments, Process Simulation, R&D, CAPA, Validation, Manufacturing, V&V, Plastics, Materials, ISO 13485, Engineering, SPC, Commercialization, Continuous Improvement, Process Engineering, Lean Manufacturing, Quality Control, Quality System, Root Cause Analysis, FMEA, 5S, Design for Manufacturing, ISO, Value Stream Mapping, Kaizen, Manufacturing Operations
Education
University of Massachusetts at Lowell 1993 — 1998
Plastics Engineer, Extrusion and Injection Molding
Greater Lawrence Tech 1989 — 1993
Electronics, Industrial Electronics Technology/Technician
Nypro, a Jabil Company March 2014 - Present
MAETRICS March 2014 - April 2014
Vention Medical, Inc. November 2012 - January 2014
Terumo Medical March 2011 - November 2012
Teleflex Medical May 2009 - November 2010
Kimberly-Clark February 2006 - May 2009
Kimberly-Clark February 2003 - May 2006
Kimberly-Clark February 1999 - May 2003
Precise Technology Inc June 1998 - September 1998
Tyco Electronics/Madison Cable May 1997 - September 1997
Skills
Materials Science, Polymers, Extrusion, Injection Molding, Rheology, Resin, Thin Films, Fiber, DOE, Design Control, Six Sigma, Minitab, Medical Devices, Medical Device Product..., Process Development, Process Improvement, Process Validation, FDA, Catheters, Photoshop, Photography, Lightroom, DMAIC, Product Development, Design of Experiments, Process Simulation, R&D, CAPA, Validation, Manufacturing, V&V, Plastics, Materials, ISO 13485, Engineering, SPC, Commercialization, Continuous Improvement, Process Engineering, Lean Manufacturing, Quality Control, Quality System, Root Cause Analysis, FMEA, 5S, Design for Manufacturing, ISO, Value Stream Mapping, Kaizen, Manufacturing Operations
Education
University of Massachusetts at Lowell 1993 — 1998
Plastics Engineer, Extrusion and Injection Molding
Greater Lawrence Tech 1989 — 1993
Electronics, Industrial Electronics Technology/Technician
Lesley McCandless Lesley McCandless's MAETRICS Experience May 2013 - December 2014
Job Complaint Specialist II with focus on Quality and Regulatory Compliance with medical devices.
Industry Pharmaceuticals
Experience
MAETRICS May 2013 - December 2014
Abbott July 2012 - December 2012
iQor November 2011 - July 2012
American Health Packaging January 2011 - April 2011
American Health Packaging July 2010 - January 2011
Praxis Packaging - Sixarp, LLC December 2009 - February 2010
Praxis Packaging - Sixarp, LLC July 2009 - November 2009
Boehringer Ingelheim Roxane, Inc. July 2005 - February 2009
Boehringer Ingelheim Roxane, Inc. January 1999 - July 2005
Boehringer Ingelheim Roxane, Inc March 1996 - January 1999
Skills
Quality Assurance, Software Documentation, GMP, Training, Management, Validation, SAP, Leadership, Sop, Team Leadership, FDA, Program Management, Human Resources, Budgets, Time Management, Root Cause Analysis, Payroll, Business Intelligence, Teamwork, Quality Control, Pharmaceutical Industry, Six Sigma, Process Improvement, Marketing Strategy, Customer Service, Troubleshooting, Project Management, Quality System, Access, Cross-functional Team..., Manufacturing, Auditing, Team Building, Vendor Management, SOP
Education
Franklin University 2008 — 2016
Business Administration and Human Resources, Minor in Marketing
Ohio Dominican University 2005 — 2007
Associates of Science, Business
MAETRICS May 2013 - December 2014
Abbott July 2012 - December 2012
iQor November 2011 - July 2012
American Health Packaging January 2011 - April 2011
American Health Packaging July 2010 - January 2011
Praxis Packaging - Sixarp, LLC December 2009 - February 2010
Praxis Packaging - Sixarp, LLC July 2009 - November 2009
Boehringer Ingelheim Roxane, Inc. July 2005 - February 2009
Boehringer Ingelheim Roxane, Inc. January 1999 - July 2005
Boehringer Ingelheim Roxane, Inc March 1996 - January 1999
Skills
Quality Assurance, Software Documentation, GMP, Training, Management, Validation, SAP, Leadership, Sop, Team Leadership, FDA, Program Management, Human Resources, Budgets, Time Management, Root Cause Analysis, Payroll, Business Intelligence, Teamwork, Quality Control, Pharmaceutical Industry, Six Sigma, Process Improvement, Marketing Strategy, Customer Service, Troubleshooting, Project Management, Quality System, Access, Cross-functional Team..., Manufacturing, Auditing, Team Building, Vendor Management, SOP
Education
Franklin University 2008 — 2016
Business Administration and Human Resources, Minor in Marketing
Ohio Dominican University 2005 — 2007
Associates of Science, Business
Dean Miller Dean Miller's MAETRICS Experience July 2013 - January 2014
Job Sr Principle Quality Engineer at R & Q Solutions
Industry Medical Devices
Experience
R&Q Solutions February 2014 - Present
MAETRICS July 2013 - January 2014
Hill-Rom June 2012 - May 2013
Zimmer February 2009 - May 2012
Allied Healthcare Products, Inc. August 2006 - February 2009
Medrad 1999 - 2006
Skills
Six Sigma Black Belt, Kepner-Tregoe, Medical Devices, ISO 13485, Design Control, CAPA, Quality System, V&V, FDA, Supplier Quality, Validation, Lean Manufacturing, Root Cause Analysis, Process Improvement, Quality Auditing, FMEA, DMAIC, GMP, SPC, Quality Management, Continuous Improvement, Quality Assurance, Six Sigma, R&D, 21 CFR Part 11, ISO, Product Launch, Minitab, Cross-functional Team..., Manufacturing, ISO 14971, Iso 9000, Change Control, Quality Control, Design of Experiments, Process Simulation, Regulatory Affairs, ISO 9000
Education
Southern Illinois University, Edwardsville 1983 — 1985
MBA, Finance
University of Missouri-Rolla 1977 — 1980
Bachelor of Science (BS), Engineering
R&Q Solutions February 2014 - Present
MAETRICS July 2013 - January 2014
Hill-Rom June 2012 - May 2013
Zimmer February 2009 - May 2012
Allied Healthcare Products, Inc. August 2006 - February 2009
Medrad 1999 - 2006
Skills
Six Sigma Black Belt, Kepner-Tregoe, Medical Devices, ISO 13485, Design Control, CAPA, Quality System, V&V, FDA, Supplier Quality, Validation, Lean Manufacturing, Root Cause Analysis, Process Improvement, Quality Auditing, FMEA, DMAIC, GMP, SPC, Quality Management, Continuous Improvement, Quality Assurance, Six Sigma, R&D, 21 CFR Part 11, ISO, Product Launch, Minitab, Cross-functional Team..., Manufacturing, ISO 14971, Iso 9000, Change Control, Quality Control, Design of Experiments, Process Simulation, Regulatory Affairs, ISO 9000
Education
Southern Illinois University, Edwardsville 1983 — 1985
MBA, Finance
University of Missouri-Rolla 1977 — 1980
Bachelor of Science (BS), Engineering
Darla Delph Darla Delph's MAETRICS Experience April 2014 - Present
Job MSN, RN, Nurse Consultant
Industry Higher Education
Experience
MAETRICS April 2014 - Present
The Ohio State University Wexner Medical Center June 2012 - Present
Medical Action Industries May 2013 - December 2014
Valident Consulting April 2013 - July 2013
Abbott June 2007 - May 2012
Nursefinders June 2002 - June 2007
GRANT MEDICAL CENTER, CHILDREN’S HOSPITAL January 1990 - June 2007
Skills
Healthcare, Medical Devices, Operating Room, Medicine, Cross-functional Team..., Surgery, Healthcare Information..., Complaint Management, Orthopedics, Medical Education, Hospitals, FDA, Nursing, Patient Safety, Managed Care, Process Improvement, Healthcare Management, Physicians, Clinical Research
Education
Ohio University
MSN, Nursing
Ohio University
Master of Science, Nursing Education
MAETRICS April 2014 - Present
The Ohio State University Wexner Medical Center June 2012 - Present
Medical Action Industries May 2013 - December 2014
Valident Consulting April 2013 - July 2013
Abbott June 2007 - May 2012
Nursefinders June 2002 - June 2007
GRANT MEDICAL CENTER, CHILDREN’S HOSPITAL January 1990 - June 2007
Skills
Healthcare, Medical Devices, Operating Room, Medicine, Cross-functional Team..., Surgery, Healthcare Information..., Complaint Management, Orthopedics, Medical Education, Hospitals, FDA, Nursing, Patient Safety, Managed Care, Process Improvement, Healthcare Management, Physicians, Clinical Research
Education
Ohio University
MSN, Nursing
Ohio University
Master of Science, Nursing Education
Roderick A. Davis, B.S.'s MAETRICS Experience December 2013 - June 2014
Job
Industry Medical Devices
Experience
Anchor Point Technology Resources July 2014 - Present
Maetrics® December 2013 - June 2014
Knowledge Services January 2013 - December 2013
Crew Technical Services, LLC / Contractor at Eli Lilly & Co. July 2012 - September 2012
Cook Pharmica December 2010 - July 2012
Eli Lilly and Company January 1991 - August 2010
Skills
Validation, CAPA, GMP, Computer System..., Aseptic Processing, Quality Control, Trackwise, Process Engineering, Sterilization, Document Management, Change Control, Requirements Analysis, Quality System..., 21 CFR, UV/Vis, Training, Lyophilization, Gas Chromatography, cGMP manufacturing, SOP development, Equipment Qualification, Aseptic Technique, Regulatory Requirements, Laboratory, GLP, ISO 13485, Biotechnology, FDA GMP, LIMS, GAMP, Medical Devices, Pharmaceutical Industry, Quality Assurance, Analytical Chemistry, HPLC, 21 CFR Part 11, Cleaning Validation, FDA, Quality System, TrackWise
Education
University of Indianapolis 2008 — 2011
Bachelor of Science (B.S.), Organizational Leadership
University of Indianapolis 2008 — 2011
Bachelor of Science (B.S.), Organizational Leadership and Chemistry
Anchor Point Technology Resources July 2014 - Present
Maetrics® December 2013 - June 2014
Knowledge Services January 2013 - December 2013
Crew Technical Services, LLC / Contractor at Eli Lilly & Co. July 2012 - September 2012
Cook Pharmica December 2010 - July 2012
Eli Lilly and Company January 1991 - August 2010
Skills
Validation, CAPA, GMP, Computer System..., Aseptic Processing, Quality Control, Trackwise, Process Engineering, Sterilization, Document Management, Change Control, Requirements Analysis, Quality System..., 21 CFR, UV/Vis, Training, Lyophilization, Gas Chromatography, cGMP manufacturing, SOP development, Equipment Qualification, Aseptic Technique, Regulatory Requirements, Laboratory, GLP, ISO 13485, Biotechnology, FDA GMP, LIMS, GAMP, Medical Devices, Pharmaceutical Industry, Quality Assurance, Analytical Chemistry, HPLC, 21 CFR Part 11, Cleaning Validation, FDA, Quality System, TrackWise
Education
University of Indianapolis 2008 — 2011
Bachelor of Science (B.S.), Organizational Leadership
University of Indianapolis 2008 — 2011
Bachelor of Science (B.S.), Organizational Leadership and Chemistry
Nicole Friscia's MAETRICS Experience May 2014 - Present
Job Compliance and Quality Consultant at Maetrics, LLC
Industry Medical Devices
Experience
MAETRICS May 2014 - Present
doTERRA Essential Oil September 2014 - December 2014
Flower Orthopedics February 2013 - February 2014
Globus Medical October 2007 - February 2013
Zurich North America May 2004 - October 2007
GlaxoSmithKline September 2001 - June 2004
Delaware Marketing Group August 1999 - July 2001
Skills
Spinal Cord Injury, Budgets, Capital Equipment, Medical Devices, Product Launch, Product Development, Management, Sales, Marketing, Cross-functional Team..., Training, Strategy, Leadership
Education
Indiana University of Pennsylvania 1993 — 1997
BA, General Fine Arts
Harcum College 1991 — 1993
AS, Interior Design
Coatesville Area Senior High 1989 — 1991
High School, College Prep, 3-12
MAETRICS May 2014 - Present
doTERRA Essential Oil September 2014 - December 2014
Flower Orthopedics February 2013 - February 2014
Globus Medical October 2007 - February 2013
Zurich North America May 2004 - October 2007
GlaxoSmithKline September 2001 - June 2004
Delaware Marketing Group August 1999 - July 2001
Skills
Spinal Cord Injury, Budgets, Capital Equipment, Medical Devices, Product Launch, Product Development, Management, Sales, Marketing, Cross-functional Team..., Training, Strategy, Leadership
Education
Indiana University of Pennsylvania 1993 — 1997
BA, General Fine Arts
Harcum College 1991 — 1993
AS, Interior Design
Coatesville Area Senior High 1989 — 1991
High School, College Prep, 3-12
Garth Smitman Garth Smitman's MAETRICS Experience April 2014 - January 2015
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
Otis R. Ketron Otis R. Ketron's MAETRICS Experience 2008 - 2009
Job OK'ay Consulting Pharma/BioTech/Medical Device
Industry Pharmaceuticals
Experience
OK'ay Consulting October 2011 - Present
Norwich Pharmaceuticals March 2012 - June 2012
St. Jude Medical October 2010 - April 2011
Genzyme, Inc. November 2009 - May 2010
Amylin 2010 - 2010
Pfizer, Inc. September 2009 - November 2009
Pfizer, Inc. September 2009 - November 2009
Monosol LLC May 2009 - September 2009
Maetrics 2008 - 2009
Medtronic 2008 - 2009
Education
Auburn University 1998 — 1998
Certificate, Project Management
University of Wisconsin-Madison 1997 — 1997
Certificate, cGMP Regulations in Engineering in the Pharmaceutical Industries
Northern KY State 1971 — 1973
OK'ay Consulting October 2011 - Present
Norwich Pharmaceuticals March 2012 - June 2012
St. Jude Medical October 2010 - April 2011
Genzyme, Inc. November 2009 - May 2010
Amylin 2010 - 2010
Pfizer, Inc. September 2009 - November 2009
Pfizer, Inc. September 2009 - November 2009
Monosol LLC May 2009 - September 2009
Maetrics 2008 - 2009
Medtronic 2008 - 2009
Education
Auburn University 1998 — 1998
Certificate, Project Management
University of Wisconsin-Madison 1997 — 1997
Certificate, cGMP Regulations in Engineering in the Pharmaceutical Industries
Northern KY State 1971 — 1973
LaChon Allen-Covington LaChon Allen-Covington's MAETRICS Experience November 2014 - 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
Gary Waikle's MAETRICS Experience October 2013 - April 2015
Job Sr. Quality Engineer at Integra LifeSciences/SeaSpine
Industry Medical Devices
Experience
SeaSpine March 2015 - Present
Maetrics October 2013 - April 2015
Allergan Medical November 2012 - June 2013
Terumo April 2011 - November 2012
Validant October 2010 - November 2012
Hospira 2010 - 2011
Abbott Vascular Devices April 2006 - June 2010
Advanced Bionics April 2005 - March 2006
TUV America March 2003 - March 2005
Advanced Sterilization 2002 - 2003
Skills
Quality Systems, Supplier Quality, Business Process..., ISO 13485, Training, Management Review, CAPA, FDA, Quality System, Document Management, Quality Management, V&V, Internal Audit, GMP, Adverse Event Reporting, Medical Devices, Quality Assurance, Quality Auditing, Design Control, ISO 14971, Root Cause Analysis, Six Sigma, GxP, Iso 9000, ISO, SPC, Risk Management, 21 CFR Part 11, Quality Control, Biotechnology, FMEA, Process Improvement, Software Documentation, Validation, Manufacturing, Aseptic Processing, Cross-functional Team..., Change Control, Auditing, Computer System..., Sop, Regulatory Submissions, Regulatory Affairs, R&D, Pharmaceutical Industry, Technology Transfer, GLP, Clinical Trials, Process Simulation, Biopharmaceuticals
Education
University of Phoenix 2006 — 2009
MBA, Business
California State University-Long Beach 1972 — 1976
BSIT, Quality Asssurance Specialty
SeaSpine March 2015 - Present
Maetrics October 2013 - April 2015
Allergan Medical November 2012 - June 2013
Terumo April 2011 - November 2012
Validant October 2010 - November 2012
Hospira 2010 - 2011
Abbott Vascular Devices April 2006 - June 2010
Advanced Bionics April 2005 - March 2006
TUV America March 2003 - March 2005
Advanced Sterilization 2002 - 2003
Skills
Quality Systems, Supplier Quality, Business Process..., ISO 13485, Training, Management Review, CAPA, FDA, Quality System, Document Management, Quality Management, V&V, Internal Audit, GMP, Adverse Event Reporting, Medical Devices, Quality Assurance, Quality Auditing, Design Control, ISO 14971, Root Cause Analysis, Six Sigma, GxP, Iso 9000, ISO, SPC, Risk Management, 21 CFR Part 11, Quality Control, Biotechnology, FMEA, Process Improvement, Software Documentation, Validation, Manufacturing, Aseptic Processing, Cross-functional Team..., Change Control, Auditing, Computer System..., Sop, Regulatory Submissions, Regulatory Affairs, R&D, Pharmaceutical Industry, Technology Transfer, GLP, Clinical Trials, Process Simulation, Biopharmaceuticals
Education
University of Phoenix 2006 — 2009
MBA, Business
California State University-Long Beach 1972 — 1976
BSIT, Quality Asssurance Specialty
Steve Jean-Philippe's MAETRICS Experience April 2013 - 2013
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
Art Augustine Art Augustine's MAETRICS Experience June 2014 - October 2014
Job QA/RA Advanced Engineer at HillRom
Industry Hospital & Health Care
Experience
Hill-Rom November 2014 - Present
MAETRICS June 2014 - October 2014
Pennsylvania Patient Safety Authority September 2004 - March 2012
ECRI Institute August 1998 - March 2012
Allegheny University Health System August 1997 - August 1998
Mediq/PRN Inc April 1994 - August 1997
Skills
Medical Devices, Healthcare, Biomedical Engineering, Preventive Maintenance, Patient Safety, Calibration, Hospitals, Technical Writing, Medical Equipment..., Cross-functional Team..., Process Improvement, Clinical Research, Hardware Diagnostics, Healthcare Information..., Radiology, Testing, Troubleshooting, Capital Equipment, Healthcare Management, Medical Imaging, Biomechanics, FDA, Medical Technology
Education
Temple University 2011 — 2011
Certificate, Project Management
Temple University 1981 — 1985
Bachelor of Science, Biomedical Engineering
Community College of Philadelphia 1978 — 1981
Associates in Applied Science, Electronic Engineering Technology
Hill-Rom November 2014 - Present
MAETRICS June 2014 - October 2014
Pennsylvania Patient Safety Authority September 2004 - March 2012
ECRI Institute August 1998 - March 2012
Allegheny University Health System August 1997 - August 1998
Mediq/PRN Inc April 1994 - August 1997
Skills
Medical Devices, Healthcare, Biomedical Engineering, Preventive Maintenance, Patient Safety, Calibration, Hospitals, Technical Writing, Medical Equipment..., Cross-functional Team..., Process Improvement, Clinical Research, Hardware Diagnostics, Healthcare Information..., Radiology, Testing, Troubleshooting, Capital Equipment, Healthcare Management, Medical Imaging, Biomechanics, FDA, Medical Technology
Education
Temple University 2011 — 2011
Certificate, Project Management
Temple University 1981 — 1985
Bachelor of Science, Biomedical Engineering
Community College of Philadelphia 1978 — 1981
Associates in Applied Science, Electronic Engineering Technology
Daniel Christodoss Daniel Christodoss's MAETRICS Experience March 2014 - May 2014
Job Principal Manufacturing Engineer at Medtronic Vascular
Industry Medical Devices
Experience
Medtronic Vascular August 2015 - Present
Phillips-Medisize January 2015 - August 2015
Philips Respironics September 2014 - January 2015
Terumo Cardiovascular Systems May 2014 - September 2014
MAETRICS March 2014 - May 2014
Zimmer Trauma September 2013 - March 2014
Helix Medical LLC March 2012 - September 2013
HeartWare Inc March 2011 - March 2012
Nipro Diagnostics Inc December 2004 - March 2011
Eli Lilly and Company May 2003 - December 2004
Skills
Engineering, Process Simulation, Manufacturing, Product Development, Lean Manufacturing, SPC, Process Improvement, Six Sigma, Medical Devices, Design Control, Validation, Design of Experiments, Automation, CAD, FDA, ISO 13485, Quality System, R&D, Cross-functional Team..., FMEA
Education
University of Madras
Bachelor of Engineering, Mechanical Engineering
Medtronic Vascular August 2015 - Present
Phillips-Medisize January 2015 - August 2015
Philips Respironics September 2014 - January 2015
Terumo Cardiovascular Systems May 2014 - September 2014
MAETRICS March 2014 - May 2014
Zimmer Trauma September 2013 - March 2014
Helix Medical LLC March 2012 - September 2013
HeartWare Inc March 2011 - March 2012
Nipro Diagnostics Inc December 2004 - March 2011
Eli Lilly and Company May 2003 - December 2004
Skills
Engineering, Process Simulation, Manufacturing, Product Development, Lean Manufacturing, SPC, Process Improvement, Six Sigma, Medical Devices, Design Control, Validation, Design of Experiments, Automation, CAD, FDA, ISO 13485, Quality System, R&D, Cross-functional Team..., FMEA
Education
University of Madras
Bachelor of Engineering, Mechanical Engineering
Jacob Foster, MBA Jacob Foster, MBA's MAETRICS Experience July 2015 - Present
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
Josephine McBride, M.B.A., B.A. Josephine McBride, M.B.A., B.A.'s MAETRICS Experience July 2014 - Present
Job Sr. Quality and Compliance Consultant
Industry Medical Devices
Experience
MAETRICS July 2014 - Present
Siemens Medical Solutions January 2010 - June 2014
General Electric April 1998 - March 2009
Boston Scientific 2009 - 2009
Skills
Medical Devices, ISO 13485, Six Sigma, FDA, Quality System, CAPA, Training, Cross-functional Team..., Process Improvement, Quality Assurance, Leadership, Quality Auditing, Validation, Root Cause Analysis, Manufacturing, Quality Management, Pharmaceutical Industry, 21 CFR, Software Documentation, Product Development, Regulatory Affairs, ISO, V&V, GMP
Education
University of Phoenix 2007 — 2009
MBA, Business
University of Phoenix 2007 — 2009
HRM, Human Resources
DeVry University 2002 — 2006
BS, Project Management
MAETRICS July 2014 - Present
Siemens Medical Solutions January 2010 - June 2014
General Electric April 1998 - March 2009
Boston Scientific 2009 - 2009
Skills
Medical Devices, ISO 13485, Six Sigma, FDA, Quality System, CAPA, Training, Cross-functional Team..., Process Improvement, Quality Assurance, Leadership, Quality Auditing, Validation, Root Cause Analysis, Manufacturing, Quality Management, Pharmaceutical Industry, 21 CFR, Software Documentation, Product Development, Regulatory Affairs, ISO, V&V, GMP
Education
University of Phoenix 2007 — 2009
MBA, Business
University of Phoenix 2007 — 2009
HRM, Human Resources
DeVry University 2002 — 2006
BS, Project Management
Lori Benson's MAETRICS Experience September 2013 - February 2015
Job Senior Medical Device Compliance and Quality Consultant at National Science Foundation
Industry Medical Devices
Experience
National Science Foundation March 2015 - Present
Maetrics September 2013 - February 2015
Eagle Laboratories September 2011 - June 2013
Aerotek Engineering July 2011 - August 2011
Consultant at Validant December 2010 - April 2011
Self Employed April 1998 - December 2010
Freudenberg-NOK October 2008 - February 2009
ASQ 1999 - 2009
OneLegacy March 2007 - April 2008
Abbott Diagnostics June 2001 - July 2004
Skills
Quality System, Quality Assurance, Quality Management, CAPA, Medical Devices, Quality Auditing, FDA, ISO 13485, GMP, Internal Audit, Quality Control, Project Management, Manufacturing, Regulatory Affairs, V&V, R&D, Injection Molding, Leadership, Product Development, ISO 14971, Training, 21 CFR Part 11, Auditing, Change Control, Cross-functional Team..., Program Management, ISO 9000, Industrial Safety, Continuous Improvement, ISO, Biotechnology, Supplier Quality, Document Management, Calibration, Pharmaceutical Industry, Process Engineering, Analysis, ISO 14001, Process Improvement, 5S, GxP, GLP, Complaint Management, TQM, SOP, Validation, Root Cause Analysis, Management, Testing
Education
University of La Verne 1987 — 1993
Bachelor of Science, Business Administration
Citrus College 1975 — 1979
AA, Art / Science
National Science Foundation March 2015 - Present
Maetrics September 2013 - February 2015
Eagle Laboratories September 2011 - June 2013
Aerotek Engineering July 2011 - August 2011
Consultant at Validant December 2010 - April 2011
Self Employed April 1998 - December 2010
Freudenberg-NOK October 2008 - February 2009
ASQ 1999 - 2009
OneLegacy March 2007 - April 2008
Abbott Diagnostics June 2001 - July 2004
Skills
Quality System, Quality Assurance, Quality Management, CAPA, Medical Devices, Quality Auditing, FDA, ISO 13485, GMP, Internal Audit, Quality Control, Project Management, Manufacturing, Regulatory Affairs, V&V, R&D, Injection Molding, Leadership, Product Development, ISO 14971, Training, 21 CFR Part 11, Auditing, Change Control, Cross-functional Team..., Program Management, ISO 9000, Industrial Safety, Continuous Improvement, ISO, Biotechnology, Supplier Quality, Document Management, Calibration, Pharmaceutical Industry, Process Engineering, Analysis, ISO 14001, Process Improvement, 5S, GxP, GLP, Complaint Management, TQM, SOP, Validation, Root Cause Analysis, Management, Testing
Education
University of La Verne 1987 — 1993
Bachelor of Science, Business Administration
Citrus College 1975 — 1979
AA, Art / Science
Amy Crisci's MAETRICS Experience September 2013 - Present
Job AP/AR Coordinator
Industry Accounting
Experience
MAETRICS September 2013 - Present
Wynstar Consulting, Inc. January 2006 - January 2015
Skills
Analytical Skills, Microsoft Excel, Microsoft Word, PowerPoint, QuickBooks, Outlook, Credit Card Transaction..., Accounts Payable, Accounts Receivable, Bookkeeping, Communication Skills, Close Attention to..., High Pressure Situations, Team Building, Positive Team Player, Payroll, Payroll Taxes, Account Reconciliation, Teamwork, Tax, Invoicing, General Ledger, Accruals, Bank Reconciliation, Journal Entries, Peachtree, Cash Receipts, Year-end Close, Petty Cash, Mas 90, Year End Accounts, Ledger, Expenses, Balance, Monthly Closing, Microsoft Dynamics SL, Checks, Vlookup, Customer Service, Microsoft Office
Education
University of Kentucky
Accounting and Business/Management
Georgetown College
Accounting and Business/Management
MAETRICS September 2013 - Present
Wynstar Consulting, Inc. January 2006 - January 2015
Skills
Analytical Skills, Microsoft Excel, Microsoft Word, PowerPoint, QuickBooks, Outlook, Credit Card Transaction..., Accounts Payable, Accounts Receivable, Bookkeeping, Communication Skills, Close Attention to..., High Pressure Situations, Team Building, Positive Team Player, Payroll, Payroll Taxes, Account Reconciliation, Teamwork, Tax, Invoicing, General Ledger, Accruals, Bank Reconciliation, Journal Entries, Peachtree, Cash Receipts, Year-end Close, Petty Cash, Mas 90, Year End Accounts, Ledger, Expenses, Balance, Monthly Closing, Microsoft Dynamics SL, Checks, Vlookup, Customer Service, Microsoft Office
Education
University of Kentucky
Accounting and Business/Management
Georgetown College
Accounting and Business/Management
Kevin Posey, BSci MBA RAC SSGB's MAETRICS Experience November 2014 - March 2015
Job Quality and Regulatory Executive Consultant
Industry Medical Devices
Experience
Validant March 2015 - Present
ASQ 2009 - Present
ASQ July 2006 - Present
MAETRICS November 2014 - March 2015
CardiacAssist, Inc. May 2012 - November 2014
Ducommun LaBarge Technologies, Inc November 2010 - February 2012
Philips Home Healthcare - Respironics June 2007 - November 2010
B. Braun Medical January 2006 - May 2007
St. Jude Medical August 2000 - October 2005
Rocketdyne (Boeing) May 1997 - August 2000
Skills
Quality System, Quality Assurance, ISO 13485, Quality Management, FDA, CAPA, Medical Devices, Six Sigma, DMAIC, Process Improvement, Design Control, Quality Auditing, Supplier Quality, V&V, ISO 14971, Statistics, Manufacturing, Lean Manufacturing, Quality Control, Testing, Continuous Improvement, Process Validation, ISO, Biomedical Engineering, Plastics, Iso 9000, Validation, Design of Experiments, Regulatory Submissions, 510 K, CE marking, Injection Molding, QSR, Quality Engineering, PMA, Engineering, Risk Management, Auditing, cGMP, IDE, Root Cause Analysis, Change Management, Cross-functional Team..., Project Management, Product Development, Medical Device R&D, GMP, SPC, R&D
Education
Penn State University, Graduate School of Business 2008 — 2010
MBA
Pennsylvania State University-Erie Campus 2008 — 2008
California Polytechnic State University-San Luis Obispo 2004 — 2005
MS
University of Southern California 1990 — 1990
MS
The University of Texas at Austin 1984 — 1989
Bachelors of Science
Lanier High School 1980 — 1984
HS Diploma
Validant March 2015 - Present
ASQ 2009 - Present
ASQ July 2006 - Present
MAETRICS November 2014 - March 2015
CardiacAssist, Inc. May 2012 - November 2014
Ducommun LaBarge Technologies, Inc November 2010 - February 2012
Philips Home Healthcare - Respironics June 2007 - November 2010
B. Braun Medical January 2006 - May 2007
St. Jude Medical August 2000 - October 2005
Rocketdyne (Boeing) May 1997 - August 2000
Skills
Quality System, Quality Assurance, ISO 13485, Quality Management, FDA, CAPA, Medical Devices, Six Sigma, DMAIC, Process Improvement, Design Control, Quality Auditing, Supplier Quality, V&V, ISO 14971, Statistics, Manufacturing, Lean Manufacturing, Quality Control, Testing, Continuous Improvement, Process Validation, ISO, Biomedical Engineering, Plastics, Iso 9000, Validation, Design of Experiments, Regulatory Submissions, 510 K, CE marking, Injection Molding, QSR, Quality Engineering, PMA, Engineering, Risk Management, Auditing, cGMP, IDE, Root Cause Analysis, Change Management, Cross-functional Team..., Project Management, Product Development, Medical Device R&D, GMP, SPC, R&D
Education
Penn State University, Graduate School of Business 2008 — 2010
MBA
Pennsylvania State University-Erie Campus 2008 — 2008
California Polytechnic State University-San Luis Obispo 2004 — 2005
MS
University of Southern California 1990 — 1990
MS
The University of Texas at Austin 1984 — 1989
Bachelors of Science
Lanier High School 1980 — 1984
HS Diploma
Sarah Mott, CMQ/OE, CQA Sarah Mott, CMQ/OE, CQA's MAETRICS Experience 2015 - Present
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
Eric Ruszkowski Eric Ruszkowski's MAETRICS Experience January 2013 - October 2014
Job Medical Devices Professional
Industry Medical Devices
Experience
MAETRICS January 2013 - October 2014
Maquet Cardiovascular LLC 1997 - 2012
Skills
Leadership, Design Control, Operating Room, Product Launch, Capital Equipment, Medical Devices, CAPA, ISO 13485, Market Development, Cross-functional Team..., Quality System, 21 CFR Part 11, FDA, Quality Assurance, Validation, Software Documentation, GMP
Education
Penn State University 1990 — 1997
Bachelor of Science (B.S.), General Sciences
MAETRICS January 2013 - October 2014
Maquet Cardiovascular LLC 1997 - 2012
Skills
Leadership, Design Control, Operating Room, Product Launch, Capital Equipment, Medical Devices, CAPA, ISO 13485, Market Development, Cross-functional Team..., Quality System, 21 CFR Part 11, FDA, Quality Assurance, Validation, Software Documentation, GMP
Education
Penn State University 1990 — 1997
Bachelor of Science (B.S.), General Sciences
Jackie McCulloch's MAETRICS Experience June 2014 - Present
Job Senior Compliance and Quality Consultant at MAETRICS
Industry Biotechnology
Experience
MAETRICS June 2014 - Present
Skills
Clinical Trials, FDA, Regulatory Affairs, CAPA, Medical Devices, computer systems..., Computer System..., Laboratory Quality..., Quality System, Remediation, FDA GMP, Auditing, Data Integrity, Regulatory Documentation, Consent Decree, Compliance Remediation, 21 CFR Part 11, GxP, Regulatory Submissions, Documentation Practices, Lifesciences, Software Documentation, Quality Assurance, Validation, GMP, ISO 13485, Sop, ISO, Quality Management, Biotechnology, LIMS, Laboratory, Laboratory Automation, GLP, R&D, Pharmaceutics, Biopharmaceuticals, Technology Transfer, IND, Regulatory Requirements, Quality Auditing, GAMP, Document Management, Pharmaceutical Industry, Quality Control, GCP, USP, Drug Development, SOP, Life Sciences
Education
Purdue University 1984 — 1987
BS / MS
St. Francis Hospital School of Medical Technology 1984 — 1985
Bachelor of Science
MAETRICS June 2014 - Present
Skills
Clinical Trials, FDA, Regulatory Affairs, CAPA, Medical Devices, computer systems..., Computer System..., Laboratory Quality..., Quality System, Remediation, FDA GMP, Auditing, Data Integrity, Regulatory Documentation, Consent Decree, Compliance Remediation, 21 CFR Part 11, GxP, Regulatory Submissions, Documentation Practices, Lifesciences, Software Documentation, Quality Assurance, Validation, GMP, ISO 13485, Sop, ISO, Quality Management, Biotechnology, LIMS, Laboratory, Laboratory Automation, GLP, R&D, Pharmaceutics, Biopharmaceuticals, Technology Transfer, IND, Regulatory Requirements, Quality Auditing, GAMP, Document Management, Pharmaceutical Industry, Quality Control, GCP, USP, Drug Development, SOP, Life Sciences
Education
Purdue University 1984 — 1987
BS / MS
St. Francis Hospital School of Medical Technology 1984 — 1985
Bachelor of Science
Lloyd Shoemaker's MAETRICS Experience April 2014 - January 2015
Job Technical Editor/Writer Lead at Alion Science and Technology
Industry Information Technology and Services
Experience
Alion Science and Technology July 2015 - Present
IPS-Integrated Project Services, Inc. January 2015 - July 2015
MAETRICS April 2014 - January 2015
DRS Technologies, Inc. October 2013 - April 2014
Wyle November 2012 - September 2013
CACI International Inc August 2009 - November 2012
Blue Force Services January 2009 - June 2009
Chenega Technology Service Corporation April 2007 - November 2008
Invivo Research, Inc. 1993 - 2006
Skills
Technical Documentation, Technical Writing, Technical Communication, Manuals, Arbortext, Reference Manuals, Guides, SharePoint, Translation, Military, Technical Training, Proposal Writing, Information Design, Software Documentation, Technical Editing, Captivate, Content Management, XML, Wikis, Quality Assurance, Information Architecture, Visio, Training, Configuration Management, Adobe Acrobat, Security Clearance
Education
University of Central Florida 1987 — 1990
Bachelor of Arts (B.A.), Philosophy
Alion Science and Technology July 2015 - Present
IPS-Integrated Project Services, Inc. January 2015 - July 2015
MAETRICS April 2014 - January 2015
DRS Technologies, Inc. October 2013 - April 2014
Wyle November 2012 - September 2013
CACI International Inc August 2009 - November 2012
Blue Force Services January 2009 - June 2009
Chenega Technology Service Corporation April 2007 - November 2008
Invivo Research, Inc. 1993 - 2006
Skills
Technical Documentation, Technical Writing, Technical Communication, Manuals, Arbortext, Reference Manuals, Guides, SharePoint, Translation, Military, Technical Training, Proposal Writing, Information Design, Software Documentation, Technical Editing, Captivate, Content Management, XML, Wikis, Quality Assurance, Information Architecture, Visio, Training, Configuration Management, Adobe Acrobat, Security Clearance
Education
University of Central Florida 1987 — 1990
Bachelor of Arts (B.A.), Philosophy
Rahn Greene Rahn Greene's MAETRICS Experience August 2013 - June 2014
Job Compliance and Regulatory Clinical Specialist at NovusLife, LLC
Industry Medical Devices
Experience
NovusLife, LLC September 2014 - Present
MAETRICS August 2013 - June 2014
Medtronic June 2001 - August 2013
Medtronic April 2011 - January 2013
Archbold Memorial Medical Center May 1996 - June 2001
Skills
Operating Room, ENT, Surgical Instruments, Medical Devices, Capital Equipment, Medical Sales, Interventional Radiology, Nursing, Perioperative Nursing, Medical/Surgical, Endoscopy, Clinical Supervision, Regulatory Requirements, Training Delivery, Red Hat Linux, Unix Operating Systems, Navigation Systems, E-Learning, Cranial, Spine, Surgical Navigation, Complaint Investigations, Product Complaints, Registered Nurses, Healthcare, FDA, PowerPoint, Process Improvement, Quality Management, ISO 13485, Compliance, Cloud Computing, Complaint Management, Clinical Research, Market Development, Product Launch, Hospitals, Surgery, Cross-functional Team..., Surgeons
Education
Chamberlain College of Nursing 2014 — 2015
Bachelor's Degree, BSN Nursing
Jacksonville University 2012 — 2014
Bachelor's Degree, Registered Nursing/Registered Nurse
Abraham Baldwin Agricultural College 1992 — 1994
Associate of Science (A.S.), Registered Nursing/Registered Nurse
Valdosta State University 1990 — 1993
Undergraduate studies for Registered Nursing/Registered Nurse
NovusLife, LLC September 2014 - Present
MAETRICS August 2013 - June 2014
Medtronic June 2001 - August 2013
Medtronic April 2011 - January 2013
Archbold Memorial Medical Center May 1996 - June 2001
Skills
Operating Room, ENT, Surgical Instruments, Medical Devices, Capital Equipment, Medical Sales, Interventional Radiology, Nursing, Perioperative Nursing, Medical/Surgical, Endoscopy, Clinical Supervision, Regulatory Requirements, Training Delivery, Red Hat Linux, Unix Operating Systems, Navigation Systems, E-Learning, Cranial, Spine, Surgical Navigation, Complaint Investigations, Product Complaints, Registered Nurses, Healthcare, FDA, PowerPoint, Process Improvement, Quality Management, ISO 13485, Compliance, Cloud Computing, Complaint Management, Clinical Research, Market Development, Product Launch, Hospitals, Surgery, Cross-functional Team..., Surgeons
Education
Chamberlain College of Nursing 2014 — 2015
Bachelor's Degree, BSN Nursing
Jacksonville University 2012 — 2014
Bachelor's Degree, Registered Nursing/Registered Nurse
Abraham Baldwin Agricultural College 1992 — 1994
Associate of Science (A.S.), Registered Nursing/Registered Nurse
Valdosta State University 1990 — 1993
Undergraduate studies for Registered Nursing/Registered Nurse
Eri Hirumi Eri Hirumi's MAETRICS Experience April 2014 - Present
Job Auditor at TÜV SÜD
Industry Medical Devices
Experience
TÜV SÜD June 2015 - Present
MAETRICS April 2014 - Present
Eri Hirumi Consulting 2012 - Present
Beckman Coulter April 2005 - October 2013
Beckman Coulter March 2004 - April 2005
Skills
FDA, CAPA, Design Control, ISO 13485, Medical Devices, Teaching,..., Quality System, Regulatory Affairs, Validation, Quality Assurance, Biotechnology, GMP, V&V, Life Sciences, Cross-functional Team..., Regulatory Requirements, Training, Risk Management, Strategy, Hardware Diagnostics, Technical Writing, Document Management
Education
California State University-Long Beach 1983 — 1987
Teaching Credential, Secondary Education and Teaching
Purdue University 1978 — 1982
Bachelor's degree, Biochemistry and Molecular Biology
TÜV SÜD June 2015 - Present
MAETRICS April 2014 - Present
Eri Hirumi Consulting 2012 - Present
Beckman Coulter April 2005 - October 2013
Beckman Coulter March 2004 - April 2005
Skills
FDA, CAPA, Design Control, ISO 13485, Medical Devices, Teaching,..., Quality System, Regulatory Affairs, Validation, Quality Assurance, Biotechnology, GMP, V&V, Life Sciences, Cross-functional Team..., Regulatory Requirements, Training, Risk Management, Strategy, Hardware Diagnostics, Technical Writing, Document Management
Education
California State University-Long Beach 1983 — 1987
Teaching Credential, Secondary Education and Teaching
Purdue University 1978 — 1982
Bachelor's degree, Biochemistry and Molecular Biology
Danielle Fazio Danielle Fazio's MAETRICS Experience September 2014 - January 2015
Job Compliance & Quality Consultant
Industry Hospital & Health Care
Experience
Certified Yoga Instructor April 2014 - Present
MAETRICS September 2014 - January 2015
MAETRICS October 2012 - March 2014
Oxford Global Resources May 2012 - October 2012
QualComp Consulting Services May 2012 - July 2012
Validant September 2011 - May 2012
Rio Salado College February 2010 - July 2010
Virtual Goody Bags, L.L.C. May 2010 - May 2010
Edward Jones October 2009 - May 2010
W.L. Gore & Associates October 2006 - June 2009
Skills
Event Planning, Event Management, Training, Educational Technology, Adult Education, Elementary Education, Quality Assurance, Regulatory Submissions, International..., MDRs, Vigilance
Education
Arizona State University 2010 — 2011
M.A., Language & Literacy, 4.0
Arizona State University 2001 — 2003
B.A., Elementary Education and Teaching
Certified Yoga Instructor April 2014 - Present
MAETRICS September 2014 - January 2015
MAETRICS October 2012 - March 2014
Oxford Global Resources May 2012 - October 2012
QualComp Consulting Services May 2012 - July 2012
Validant September 2011 - May 2012
Rio Salado College February 2010 - July 2010
Virtual Goody Bags, L.L.C. May 2010 - May 2010
Edward Jones October 2009 - May 2010
W.L. Gore & Associates October 2006 - June 2009
Skills
Event Planning, Event Management, Training, Educational Technology, Adult Education, Elementary Education, Quality Assurance, Regulatory Submissions, International..., MDRs, Vigilance
Education
Arizona State University 2010 — 2011
M.A., Language & Literacy, 4.0
Arizona State University 2001 — 2003
B.A., Elementary Education and Teaching
Akshay Patel Akshay Patel's MAETRICS Experience January 2015 - Present
Job Manager, Solutions Delivery at MAETRICS
Industry Pharmaceuticals
Experience
MAETRICS January 2015 - Present
MAETRICS November 2012 - December 2014
Baxter Healthcare June 2011 - October 2012
University of Illinois at Chicago January 2010 - May 2011
Skills
Proficient PC use, PowerPoint, Microsoft Office, Data Analysis, Microsoft Excel, Research, DNA extraction, Pharmaceutical Industry, Microsoft Word, HPLC, Statistics, FDA, Healthcare, Lifesciences, Western Blotting, Quality Assurance, CAPA, Biomedical Engineering, GMP, Biochemistry, Biotechnology, Laboratory, Chemistry, Clinical Trials, Cross-functional Team..., Life Sciences
Education
Carnegie Mellon University 2015 — 2018
Master of Business Administration (M.B.A.)
University of Illinois at Chicago 2007 — 2011
B.S., Neuroscience
Elk Grove High School 2003 — 2007
MAETRICS January 2015 - Present
MAETRICS November 2012 - December 2014
Baxter Healthcare June 2011 - October 2012
University of Illinois at Chicago January 2010 - May 2011
Skills
Proficient PC use, PowerPoint, Microsoft Office, Data Analysis, Microsoft Excel, Research, DNA extraction, Pharmaceutical Industry, Microsoft Word, HPLC, Statistics, FDA, Healthcare, Lifesciences, Western Blotting, Quality Assurance, CAPA, Biomedical Engineering, GMP, Biochemistry, Biotechnology, Laboratory, Chemistry, Clinical Trials, Cross-functional Team..., Life Sciences
Education
Carnegie Mellon University 2015 — 2018
Master of Business Administration (M.B.A.)
University of Illinois at Chicago 2007 — 2011
B.S., Neuroscience
Elk Grove High School 2003 — 2007
Robert Lee MS, RAC, CQA Robert Lee MS, RAC, CQA's MAETRICS Experience May 2013 - August 2013
Job Regulatory Affairs Specialist at Abbott
Industry Medical Devices
Experience
Abbott June 2014 - Present
OptiMedica February 2014 - June 2014
Thermo Fisher Scientific October 2013 - February 2014
Maetrics May 2013 - August 2013
Stryker May 2007 - May 2013
Boston Scientific June 2004 - May 2007
Skills
FDA, Document Management, ISO 13485, Design Control, Design History, GMP, Technical Writing, Medical Devices, Regulatory Affairs, Quality System, Device Master Record..., CAPA, V&V, Cross-functional Team..., R&D, Six Sigma, Change Control, Software Documentation, Biomedical Engineering, Validation, Product Development, Manufacturing, Regulatory Submissions, Clinical Development, 21 CFR Part 11, GxP, Sop, Regulatory Requirements, Quality Auditing, Process Simulation, Minitab, Quality Control, ISO, Root Cause Analysis, Quality Management, Design of Experiments, DMAIC, FMEA, Pharmaceutical Industry, Quality Assurance
Education
Northeastern University 2007 — 2009
Master Of Science, Regulatory Affairs for Drugs, Biologics, and Medical Devices, 3.5 GPA
Bellevue University 2006 — 2008
Bachelor of Science, Business Information Systems, 3.9 GPA
Abbott June 2014 - Present
OptiMedica February 2014 - June 2014
Thermo Fisher Scientific October 2013 - February 2014
Maetrics May 2013 - August 2013
Stryker May 2007 - May 2013
Boston Scientific June 2004 - May 2007
Skills
FDA, Document Management, ISO 13485, Design Control, Design History, GMP, Technical Writing, Medical Devices, Regulatory Affairs, Quality System, Device Master Record..., CAPA, V&V, Cross-functional Team..., R&D, Six Sigma, Change Control, Software Documentation, Biomedical Engineering, Validation, Product Development, Manufacturing, Regulatory Submissions, Clinical Development, 21 CFR Part 11, GxP, Sop, Regulatory Requirements, Quality Auditing, Process Simulation, Minitab, Quality Control, ISO, Root Cause Analysis, Quality Management, Design of Experiments, DMAIC, FMEA, Pharmaceutical Industry, Quality Assurance
Education
Northeastern University 2007 — 2009
Master Of Science, Regulatory Affairs for Drugs, Biologics, and Medical Devices, 3.5 GPA
Bellevue University 2006 — 2008
Bachelor of Science, Business Information Systems, 3.9 GPA
Sanda Dracic, MJ's MAETRICS Experience February 2013 - October 2013
Job Quality Systems Management at Stryker
Industry Medical Devices
Experience
Stryker July 2015 - Present
Intuitive Surgical November 2011 - July 2015
Maetrics February 2013 - October 2013
American Academy of Orthopaedic Surgeons March 2011 - October 2011
Baxter Healthcare January 2010 - March 2011
MedStaff Alternatives May 2008 - January 2010
Skills
FDA, CAPA, Regulatory Affairs, Process Improvement..., Quality System, CFR, Medical Devices, ISO 13485, GMP, Pharmaceutical Industry, Quality Assurance, Sop, Pharmacovigilance, Healthcare, Complaint Management, Regulatory Requirements, Patient Safety, Trackwise, Regulations, GxP, 21 CFR, Quality Control, Quality Auditing, Quality Management, Clinical Research, Team Leadership, Validation, FDA GMP, Orthopedic, Change Control, ISO 14971, V&V, Clinical Trials, SOP
Education
Loyola University Chicago School of Law 2010 — 2012
Master’s Degree, Health Law
Loyola University Chicago 2007 — 2010
Bachelor’s Degree, Health Systems Management
University of California
Regulatory Affairs Certificate
Stryker July 2015 - Present
Intuitive Surgical November 2011 - July 2015
Maetrics February 2013 - October 2013
American Academy of Orthopaedic Surgeons March 2011 - October 2011
Baxter Healthcare January 2010 - March 2011
MedStaff Alternatives May 2008 - January 2010
Skills
FDA, CAPA, Regulatory Affairs, Process Improvement..., Quality System, CFR, Medical Devices, ISO 13485, GMP, Pharmaceutical Industry, Quality Assurance, Sop, Pharmacovigilance, Healthcare, Complaint Management, Regulatory Requirements, Patient Safety, Trackwise, Regulations, GxP, 21 CFR, Quality Control, Quality Auditing, Quality Management, Clinical Research, Team Leadership, Validation, FDA GMP, Orthopedic, Change Control, ISO 14971, V&V, Clinical Trials, SOP
Education
Loyola University Chicago School of Law 2010 — 2012
Master’s Degree, Health Law
Loyola University Chicago 2007 — 2010
Bachelor’s Degree, Health Systems Management
University of California
Regulatory Affairs Certificate
Barbara Lamoureux's MAETRICS Experience May 2014 - Present
Job Lead Auditor and Microbiologist
Industry Medical Devices
Experience
Acclarent January 2015 - Present
MAETRICS May 2014 - Present
Covidien January 2008 - May 2014
Becton Dickinson - PASCO 1985 - 2007
Skills
FDA GMP, ISO 13485, CMDR, Internal Audit, Compliance, Microbiology, Medical Devices, IVD, Manufacturing, Quality Assurance, Quality System, CAPA, Certified Lead Auditor, CQA, Design Control, FDA, Quality Management, ISO 14971, ISO, Auditing, GCP, Regulatory Requirements, Validation, CE marking, 21 CFR, Medical Device Directive, R&D, 21 CFR Part 11, Change Control, Regulatory Affairs
Education
New York Institute of Technology-Old Westbury 1978 — 1981
Bachelor of Science (B.S.), Biomedical Sciences, General / Microbiology
SUNY Farmingdale, NY 1976 — 1978
Associate of Science (A.S.), Biology, General
Acclarent January 2015 - Present
MAETRICS May 2014 - Present
Covidien January 2008 - May 2014
Becton Dickinson - PASCO 1985 - 2007
Skills
FDA GMP, ISO 13485, CMDR, Internal Audit, Compliance, Microbiology, Medical Devices, IVD, Manufacturing, Quality Assurance, Quality System, CAPA, Certified Lead Auditor, CQA, Design Control, FDA, Quality Management, ISO 14971, ISO, Auditing, GCP, Regulatory Requirements, Validation, CE marking, 21 CFR, Medical Device Directive, R&D, 21 CFR Part 11, Change Control, Regulatory Affairs
Education
New York Institute of Technology-Old Westbury 1978 — 1981
Bachelor of Science (B.S.), Biomedical Sciences, General / Microbiology
SUNY Farmingdale, NY 1976 — 1978
Associate of Science (A.S.), Biology, General
Peter Luna's MAETRICS Experience June 2015 - Present
Job Product Development Engineer at MAETRICS
Industry Medical Devices
Experience
MAETRICS June 2015 - Present
ALKU January 2015 - May 2015
Depuy Synthes - West Chester (Maetrics Consultant) March 2014 - December 2014
Great Batch Medical January 2014 - March 2014
Depuy Synthes Power Tools (Maetrics Contractor) February 2013 - December 2013
Hospira Inc. June 2012 - February 2013
Hospira Inc. February 2012 - June 2012
Posey Company June 2011 - December 2011
Abbott Diagnostics August 2007 - December 2010
Lockheed Martin Missiles and Fire Control October 1987 - May 2007
Skills
Medical Devices, Root Cause Analysis, CAPA, Manufacturing, Systems Engineering, Analog Circuit Design, Test Equipment, Product Validation, Testing
Education
Amberton University 1984 — 1986
Master of Business Administration (MBA), Management Science
University of Oklahoma 1975 — 1980
BSEE, Electronics
MAETRICS June 2015 - Present
ALKU January 2015 - May 2015
Depuy Synthes - West Chester (Maetrics Consultant) March 2014 - December 2014
Great Batch Medical January 2014 - March 2014
Depuy Synthes Power Tools (Maetrics Contractor) February 2013 - December 2013
Hospira Inc. June 2012 - February 2013
Hospira Inc. February 2012 - June 2012
Posey Company June 2011 - December 2011
Abbott Diagnostics August 2007 - December 2010
Lockheed Martin Missiles and Fire Control October 1987 - May 2007
Skills
Medical Devices, Root Cause Analysis, CAPA, Manufacturing, Systems Engineering, Analog Circuit Design, Test Equipment, Product Validation, Testing
Education
Amberton University 1984 — 1986
Master of Business Administration (MBA), Management Science
University of Oklahoma 1975 — 1980
BSEE, Electronics
Brian Mcallister's MAETRICS Experience June 2015 - Present
Job Vice President Business Development at MAETRICS
Industry Pharmaceuticals
Experience
MAETRICS June 2015 - Present
inVentiv Health October 2009 - June 2015
Rules Based Medicine March 2008 - October 2009
AAIPharma October 2006 - October 2007
PRA International 2004 - 2006
Covance 2002 - 2004
Quest Diagnostics January 1990 - November 2001
Skills
Clinical Trials, CRO, Biotechnology, Clinical Development, Lifesciences, Oncology, Clinical Research, Pharmaceutical Industry, EDC, Drug Development, CTMS, Validation, Infectious Diseases, Biopharmaceuticals, GCP, Drug Discovery, Hardware Diagnostics, Clinical Data Management, Business Development, Vaccines, Regulatory Affairs, Neurology, Cardiology, Clinical Monitoring, ICH-GCP, Life Sciences, Commercialization, Pharmacovigilance, Business Strategy
Education
University of Scranton 1975 — 1979
BS
MAETRICS June 2015 - Present
inVentiv Health October 2009 - June 2015
Rules Based Medicine March 2008 - October 2009
AAIPharma October 2006 - October 2007
PRA International 2004 - 2006
Covance 2002 - 2004
Quest Diagnostics January 1990 - November 2001
Skills
Clinical Trials, CRO, Biotechnology, Clinical Development, Lifesciences, Oncology, Clinical Research, Pharmaceutical Industry, EDC, Drug Development, CTMS, Validation, Infectious Diseases, Biopharmaceuticals, GCP, Drug Discovery, Hardware Diagnostics, Clinical Data Management, Business Development, Vaccines, Regulatory Affairs, Neurology, Cardiology, Clinical Monitoring, ICH-GCP, Life Sciences, Commercialization, Pharmacovigilance, Business Strategy
Education
University of Scranton 1975 — 1979
BS
Nakia Edwards's MAETRICS Experience March 2013 - August 2014
Job Compliance Consultant for Medical Device/Pharmaceutical Companies
Industry Pharmaceuticals
Experience
Validant August 2014 - Present
MAETRICS March 2013 - August 2014
Alcon Laboratories, Inc. June 2012 - March 2013
AmPharmCo., Inc. January 2006 - June 2012
Skills
Process Improvement, Software Documentation, Testing, Quality Assurance, Quality System, Validation, Medical Devices, Sop, GMP, Quality Control, Training, Microsoft Office, Pharmaceutical Industry, FDA, 21 CFR Part 11, Leadership
Education
University of Louisiana at Monroe 1992 — 2000
Huntington High School
Validant August 2014 - Present
MAETRICS March 2013 - August 2014
Alcon Laboratories, Inc. June 2012 - March 2013
AmPharmCo., Inc. January 2006 - June 2012
Skills
Process Improvement, Software Documentation, Testing, Quality Assurance, Quality System, Validation, Medical Devices, Sop, GMP, Quality Control, Training, Microsoft Office, Pharmaceutical Industry, FDA, 21 CFR Part 11, Leadership
Education
University of Louisiana at Monroe 1992 — 2000
Huntington High School
C. David Luckenbaugh's MAETRICS Experience January 2006 - September 2008
Job Sr. Quality Assurance Associate at PwC
Industry Pharmaceuticals
Experience
PwC January 2009 - Present
Maetrics January 2006 - September 2008
BMS 1998 - 2006
Skills
Computer System..., Quality Assurance, Medical Devices, Process Validation, Certified Project..., Quality Auditing, Lifesciences, V&V, IT Strategy, Quality System, Sop, FDA, Manufacturing, Biotechnology, Validation, Cross-functional Team..., Quality Management, Process Engineering, SOP
Education
Penn State University 1988 — 1993
Bachelor of Science, Chemical Engineering
PwC January 2009 - Present
Maetrics January 2006 - September 2008
BMS 1998 - 2006
Skills
Computer System..., Quality Assurance, Medical Devices, Process Validation, Certified Project..., Quality Auditing, Lifesciences, V&V, IT Strategy, Quality System, Sop, FDA, Manufacturing, Biotechnology, Validation, Cross-functional Team..., Quality Management, Process Engineering, SOP
Education
Penn State University 1988 — 1993
Bachelor of Science, Chemical Engineering
Harold Hardaway Jr's MAETRICS Experience October 2004 - March 2006
Job Validation Software/Equipment
Industry Pharmaceuticals
Experience
Dow AgroSciences July 2014 - Present
Kelly Services November 2012 - July 2014
Clarke Engineering Services April 2012 - November 2012
Boston Scientific October 2009 - April 2012
inVentiv Clinical Solutions June 2008 - August 2009
Hardaway Validation Services, Inc March 2006 - December 2008
CAH November 2006 - April 2008
Grizzle Compliance Consulting March 2006 - August 2006
Maetrics October 2004 - March 2006
Computer Task Group December 2002 - September 2004
Skills
Validation, Sop, Quality System, Biotechnology, LIMS, HPLC, Computer System..., 21 CFR Part 11, FDA, ISO 13485, Change Control, GMP, Software Documentation, Six Sigma, Process Simulation, Manufacturing, Medical Devices, Quality Auditing, Root Cause Analysis, Quality Assurance, CAPA, V, GxP, SOP, GLP, Document Management
Education
Olivet Nazarene University 2011 — 2012
Bachelor's of Science, Business Management
Kankakee Community College 1995 — 1997
Associates, Science
Dow AgroSciences July 2014 - Present
Kelly Services November 2012 - July 2014
Clarke Engineering Services April 2012 - November 2012
Boston Scientific October 2009 - April 2012
inVentiv Clinical Solutions June 2008 - August 2009
Hardaway Validation Services, Inc March 2006 - December 2008
CAH November 2006 - April 2008
Grizzle Compliance Consulting March 2006 - August 2006
Maetrics October 2004 - March 2006
Computer Task Group December 2002 - September 2004
Skills
Validation, Sop, Quality System, Biotechnology, LIMS, HPLC, Computer System..., 21 CFR Part 11, FDA, ISO 13485, Change Control, GMP, Software Documentation, Six Sigma, Process Simulation, Manufacturing, Medical Devices, Quality Auditing, Root Cause Analysis, Quality Assurance, CAPA, V, GxP, SOP, GLP, Document Management
Education
Olivet Nazarene University 2011 — 2012
Bachelor's of Science, Business Management
Kankakee Community College 1995 — 1997
Associates, Science
David Lynch's MAETRICS Experience 2015 - Present
Job Vice President, Business Development
Industry Medical Devices
Experience
MAETRICS 2015 - Present
Affymetrix 2013 - 2015
PPD 2009 - 2013
CRI Inc 2006 - 2009
Arthur D. Little 2003 - 2006
Massachusetts Department of Public Health 2002 - 2003
Skills
Biotechnology, Lifesciences, Assay Development, Medical Devices, Leadership, Product Launch, Drug Discovery, New Business Development, Molecular Biology, Sales Operations, Biomarkers, R&D, Life Sciences, Biochemistry, Genomics, Immunoassays, Pharmaceutical Industry, Protein Chemistry, Go-to-market Strategy
Education
University of Pittsburgh School of Public Health 1996 — 2002
PhD, Infectious Diseases & Microbiology
Syracuse University 1992 — 1996
BS, Biology
MAETRICS 2015 - Present
Affymetrix 2013 - 2015
PPD 2009 - 2013
CRI Inc 2006 - 2009
Arthur D. Little 2003 - 2006
Massachusetts Department of Public Health 2002 - 2003
Skills
Biotechnology, Lifesciences, Assay Development, Medical Devices, Leadership, Product Launch, Drug Discovery, New Business Development, Molecular Biology, Sales Operations, Biomarkers, R&D, Life Sciences, Biochemistry, Genomics, Immunoassays, Pharmaceutical Industry, Protein Chemistry, Go-to-market Strategy
Education
University of Pittsburgh School of Public Health 1996 — 2002
PhD, Infectious Diseases & Microbiology
Syracuse University 1992 — 1996
BS, Biology
Heather Stipp Turner's MAETRICS Experience August 2006 - March 2009
Job Quality & Regulatory Director New Product Development at Nexus Medical
Industry Medical Devices
Experience
Nexus Medical March 2009 - Present
Maetrics August 2006 - March 2009
Aptuit February 2003 - August 2006
Aventis Behring June 2001 - December 2002
IIT Research Institute August 2000 - May 2001
Koch Industries 1996 - 1997
Skills
Medical Devices, Quality System, FDA, Product Development, GMP, ISO 13485, V&V
Education
Keller Graduate School of Management 2006 — 2008
MPM, Project Management
University of Kansas Medical Center 1997 — 2000
MA, Microbiology, Immunology, Virology
University of Saint Mary 1992 — 1996
BS, Biology and Chemistry
Northwest High School
Northwest High School
Wichita Northwest High School
Nexus Medical March 2009 - Present
Maetrics August 2006 - March 2009
Aptuit February 2003 - August 2006
Aventis Behring June 2001 - December 2002
IIT Research Institute August 2000 - May 2001
Koch Industries 1996 - 1997
Skills
Medical Devices, Quality System, FDA, Product Development, GMP, ISO 13485, V&V
Education
Keller Graduate School of Management 2006 — 2008
MPM, Project Management
University of Kansas Medical Center 1997 — 2000
MA, Microbiology, Immunology, Virology
University of Saint Mary 1992 — 1996
BS, Biology and Chemistry
Northwest High School
Northwest High School
Wichita Northwest High School
Mary Moriva's MAETRICS Experience 2008 - 2009
Job Executive Quality Consultant at Regulatory Compliance Associates, Inc.
Industry Pharmaceuticals
Experience
Regulatory Compliance Associates, Inc. May 2013 - Present
American Renolit Corporation LA July 2009 - Present
Maetrics 2008 - 2009
RCA Consulting 2008 - 2008
Leiner Health Products 2007 - 2007
Pharmaceutical Systems, Inc. 1994 - 2006
Skills
Quality System, Medical Devices, Validation, Manufacturing, V&V, ISO 13485, Change Control, Quality Assurance, FDA, CAPA, Quality Auditing, GMP, Process Improvement, ISO, Continuous Improvement, Six Sigma, Analysis, Sop, Cross-functional Team..., Microsoft Excel
Education
Lake Forest Graduate School of Management
Business
Regulatory Compliance Associates, Inc. May 2013 - Present
American Renolit Corporation LA July 2009 - Present
Maetrics 2008 - 2009
RCA Consulting 2008 - 2008
Leiner Health Products 2007 - 2007
Pharmaceutical Systems, Inc. 1994 - 2006
Skills
Quality System, Medical Devices, Validation, Manufacturing, V&V, ISO 13485, Change Control, Quality Assurance, FDA, CAPA, Quality Auditing, GMP, Process Improvement, ISO, Continuous Improvement, Six Sigma, Analysis, Sop, Cross-functional Team..., Microsoft Excel
Education
Lake Forest Graduate School of Management
Business
Tony Paz's MAETRICS Experience August 2006 - September 2009
Job Sr. Principal Engineer Baxter Healthcare
Industry Medical Devices
Experience
Baxter Healthcare October 2009 - Present
Maetrics August 2006 - September 2009
Tyco Healthcare October 2005 - August 2006
Earth Tech June 2003 - October 2005
Pharmtech May 2002 - July 2003
Northfield Laboratories September 1998 - May 2002
Skills
FDA, V&V, 21 CFR Part 11, GMP, Validation, ISO 13485, Design Control, Quality System, Medical Devices, FDA GMP, CAPA, ISO, ISO 14971, Change Control
Education
Grand Canyon University 1995 — 1998
Baxter Healthcare October 2009 - Present
Maetrics August 2006 - September 2009
Tyco Healthcare October 2005 - August 2006
Earth Tech June 2003 - October 2005
Pharmtech May 2002 - July 2003
Northfield Laboratories September 1998 - May 2002
Skills
FDA, V&V, 21 CFR Part 11, GMP, Validation, ISO 13485, Design Control, Quality System, Medical Devices, FDA GMP, CAPA, ISO, ISO 14971, Change Control
Education
Grand Canyon University 1995 — 1998
Sheri Becker's MAETRICS Experience 2014 - 2015
Job Records Administrator at Seminole Tribe of Florida
Industry Information Services
Experience
Seminole Tribe of Florida February 2015 - Present
MAETRICS 2014 - 2015
AstraZeneca 2010 - 2013
AstraZeneca 2008 - 2009
AstraZeneca 2002 - December 2007
Skills
Records Management, Change Management, Document Management, Operations Management, Line Management, Project Management, SharePoint, Training, Leadership, Documentum, CRO, Strategy, Software Documentation, Food & Beverage, Casino Gaming, Tour Management, Management, Business Process..., Validation, Vendor Management, Performance Management, Sop, CRM, Outsourcing, Human Resources, Coaching
Education
Immaculata University 2007 — 2010
Bachelor's degree, Organizational Dynamics/Business
Immaculata University 2007 — 2010
Bachelor's degree, Human Resources (HR) General Management/Personnel Administration
Parsippany Hills
Seminole Tribe of Florida February 2015 - Present
MAETRICS 2014 - 2015
AstraZeneca 2010 - 2013
AstraZeneca 2008 - 2009
AstraZeneca 2002 - December 2007
Skills
Records Management, Change Management, Document Management, Operations Management, Line Management, Project Management, SharePoint, Training, Leadership, Documentum, CRO, Strategy, Software Documentation, Food & Beverage, Casino Gaming, Tour Management, Management, Business Process..., Validation, Vendor Management, Performance Management, Sop, CRM, Outsourcing, Human Resources, Coaching
Education
Immaculata University 2007 — 2010
Bachelor's degree, Organizational Dynamics/Business
Immaculata University 2007 — 2010
Bachelor's degree, Human Resources (HR) General Management/Personnel Administration
Parsippany Hills
Angela Dodoo's MAETRICS Experience November 2008 - April 2009
Job Corporate QAQS&Compliance ASQ CQA at Takeda Pharmaceuticals International Co.
Industry Pharmaceuticals
Experience
Takeda Pharmaceuticals International Co. February 2014 - Present
Medical Device Company July 2013 - February 2014
Lonza April 2012 - June 2013
ProPharma Group November 2011 - April 2012
Thermo Fisher Scientific 2010 - 2011
Bioanalytical Systems Inc. (BASi), April 2009 - November 2009
Maetrics November 2008 - April 2009
Eli Lilly 2008 - November 2008
Baxter 2006 - 2008
Skills
CAPA, GMP, Quality Assurance, Validation, Sop, Biotechnology, Pharmaceutical Industry, Quality System, Change Control, Analytical Chemistry, Quality Control, V&V, GxP, Cleaning Validation, 21 CFR Part 11, Regulatory Affairs, LIMS, Aseptic Processing, Biopharmaceuticals, FDA, Trackwise, Aseptic Technique, Technology Transfer, ISO 13485, Purification, Regulatory Requirements, Lifesciences, UV/Vis, GCP, Regulatory Submissions, Vaccines, ELISA, Microbiology, Chromatography, Deviations, CRO, Computer System..., cGMP practices, Cell Culture, Fermentation, Medical Devices, Document Management, GAMP, HPLC, Drug Development, SOP development, GLP, Protein Chemistry, Sterilization, Quality Auditing
Education
Purdue University 1999 — 2004
Bachelor's of Science, Pharmaceutical Sciences
Hightstown High School
Takeda Pharmaceuticals International Co. February 2014 - Present
Medical Device Company July 2013 - February 2014
Lonza April 2012 - June 2013
ProPharma Group November 2011 - April 2012
Thermo Fisher Scientific 2010 - 2011
Bioanalytical Systems Inc. (BASi), April 2009 - November 2009
Maetrics November 2008 - April 2009
Eli Lilly 2008 - November 2008
Baxter 2006 - 2008
Skills
CAPA, GMP, Quality Assurance, Validation, Sop, Biotechnology, Pharmaceutical Industry, Quality System, Change Control, Analytical Chemistry, Quality Control, V&V, GxP, Cleaning Validation, 21 CFR Part 11, Regulatory Affairs, LIMS, Aseptic Processing, Biopharmaceuticals, FDA, Trackwise, Aseptic Technique, Technology Transfer, ISO 13485, Purification, Regulatory Requirements, Lifesciences, UV/Vis, GCP, Regulatory Submissions, Vaccines, ELISA, Microbiology, Chromatography, Deviations, CRO, Computer System..., cGMP practices, Cell Culture, Fermentation, Medical Devices, Document Management, GAMP, HPLC, Drug Development, SOP development, GLP, Protein Chemistry, Sterilization, Quality Auditing
Education
Purdue University 1999 — 2004
Bachelor's of Science, Pharmaceutical Sciences
Hightstown High School
Sandra Boyd-Spoden's MAETRICS Experience January 2014 - July 2014
Job Sr. Quality Engineer at Current Company
Industry Pharmaceuticals
Experience
Current Company August 2014 - Present
MAETRICS January 2014 - July 2014
DaVita Labs October 2011 - January 2014
Peregrine Pharmaceuticals December 2010 - October 2011
Sport Chalet June 2008 - October 2011
Avail Medical/Flextronics 2005 - 2010
Toshiba America Information Systems 2001 - 2004
Alphalogix 2000 - 2001
B.Braun 1995 - 2000
Baxter Healthcare 1990 - 1995
Skills
FDA, 21 CFR Part 11, Validation, GMP, CAPA, Medical Devices, ISO 13485, Quality System, V&V, Computer System..., Regulatory Affairs, Pharmaceutical Industry, Sop, Clinical Research, Biotechnology, GxP, Six Sigma, Quality Assurance, Change Control, Quality Auditing, LIMS, Sterilization, Clinical Trials, GLP, Cleaning Validation, ISO 14971, Regulatory Requirements, Biopharmaceuticals, Testing, R&D, GCP, Microbiology, Calibration, 21 CFR, Aseptic Processing, Pharmaceutics, Software Documentation, Aseptic Technique, Regulatory Submissions, Laboratory, FDA GMP, Design Control, GAMP, Cross-functional Team..., Technology Transfer, Trackwise, Quality Control, CQA, Quality Management, Lifesciences
Education
University of California, Irvine
Bachelor of Science, Biological Sciences
University of California, Irvine
Current Company August 2014 - Present
MAETRICS January 2014 - July 2014
DaVita Labs October 2011 - January 2014
Peregrine Pharmaceuticals December 2010 - October 2011
Sport Chalet June 2008 - October 2011
Avail Medical/Flextronics 2005 - 2010
Toshiba America Information Systems 2001 - 2004
Alphalogix 2000 - 2001
B.Braun 1995 - 2000
Baxter Healthcare 1990 - 1995
Skills
FDA, 21 CFR Part 11, Validation, GMP, CAPA, Medical Devices, ISO 13485, Quality System, V&V, Computer System..., Regulatory Affairs, Pharmaceutical Industry, Sop, Clinical Research, Biotechnology, GxP, Six Sigma, Quality Assurance, Change Control, Quality Auditing, LIMS, Sterilization, Clinical Trials, GLP, Cleaning Validation, ISO 14971, Regulatory Requirements, Biopharmaceuticals, Testing, R&D, GCP, Microbiology, Calibration, 21 CFR, Aseptic Processing, Pharmaceutics, Software Documentation, Aseptic Technique, Regulatory Submissions, Laboratory, FDA GMP, Design Control, GAMP, Cross-functional Team..., Technology Transfer, Trackwise, Quality Control, CQA, Quality Management, Lifesciences
Education
University of California, Irvine
Bachelor of Science, Biological Sciences
University of California, Irvine
David Wilkerson's MAETRICS Experience May 2013 - January 2015
Job Senior Quality Engineer
Industry Medical Devices
Experience
St. Jude Medical August 2015 - Present
IntePros Consulting May 2015 - August 2015
MAETRICS May 2013 - January 2015
Cyberonics June 2010 - November 2012
Cisco May 2008 - August 2008
TradeSTAR, Inc May 2007 - August 2007
Texas A&M Dept. of ResLife August 2005 - May 2006
SWC Engineering June 2005 - August 2005
Skills
Biomedical Engineering, FDA, Medical Devices, ISO 13485, CAPA, Matlab, Quality System, Root Cause Analysis, Manufacturing, Testing, Biomechanics, Nanotechnology, Labview, Engineering, ISO 14971, Neurostimulation, Complaint Management, Complaint Investigations, Technical Support, Validation, Quality Assurance, Quality System..., SAP, Team Leadership
Education
Texas A&M University 2004 — 2008
Bachelor of Science (B.S.), Biomedical/Medical Engineering
St. Jude Medical August 2015 - Present
IntePros Consulting May 2015 - August 2015
MAETRICS May 2013 - January 2015
Cyberonics June 2010 - November 2012
Cisco May 2008 - August 2008
TradeSTAR, Inc May 2007 - August 2007
Texas A&M Dept. of ResLife August 2005 - May 2006
SWC Engineering June 2005 - August 2005
Skills
Biomedical Engineering, FDA, Medical Devices, ISO 13485, CAPA, Matlab, Quality System, Root Cause Analysis, Manufacturing, Testing, Biomechanics, Nanotechnology, Labview, Engineering, ISO 14971, Neurostimulation, Complaint Management, Complaint Investigations, Technical Support, Validation, Quality Assurance, Quality System..., SAP, Team Leadership
Education
Texas A&M University 2004 — 2008
Bachelor of Science (B.S.), Biomedical/Medical Engineering
Joe Simon's MAETRICS Experience April 2013 - Present
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
Acacia Semler's MAETRICS Experience October 2014 - Present
Job Compliance and Quality Consultant at MAETRICS
Industry Medical Devices
Experience
MAETRICS October 2014 - Present
MAETRICS July 2013 - September 2014
MAETRICS December 2012 - July 2013
Baxter Healthcare November 2010 - April 2012
Vee Pak, Inc January 2009 - October 2010
ChemPoint.com May 2008 - November 2008
Cardinal McCarrick High School January 2007 - January 2008
Center of Advanced Biotechnology and Medicine January 2006 - August 2006
Skills
FDA, Wet Chemistry, Analytical Chemistry, UV/Vis, Pharmaceutical Industry, GLP, LIMS, Gas Chromatography, 21 CFR Part 11, CAPA, Quality System, Chemistry
Education
Rutgers University-New Brunswick 2003 — 2007
B.S, Chemistry
MAETRICS October 2014 - Present
MAETRICS July 2013 - September 2014
MAETRICS December 2012 - July 2013
Baxter Healthcare November 2010 - April 2012
Vee Pak, Inc January 2009 - October 2010
ChemPoint.com May 2008 - November 2008
Cardinal McCarrick High School January 2007 - January 2008
Center of Advanced Biotechnology and Medicine January 2006 - August 2006
Skills
FDA, Wet Chemistry, Analytical Chemistry, UV/Vis, Pharmaceutical Industry, GLP, LIMS, Gas Chromatography, 21 CFR Part 11, CAPA, Quality System, Chemistry
Education
Rutgers University-New Brunswick 2003 — 2007
B.S, Chemistry
Christopher Gonzales, CQA's MAETRICS Experience March 2014 - June 2014
Job CQA
Industry Medical Devices
Experience
DePuy Synthes - Johnson and Johnson August 2014 - Present
MAETRICS March 2014 - June 2014
Medtronic October 2013 - February 2014
Exel September 2012 - September 2013
Ortho Clinical Diagnostics April 2011 - August 2012
Merck November 2009 - April 2011
Amgen July 2003 - September 2006
Immunex May 2000 - July 2003
Pharmacia February 2000 - May 2001
Home Access Health Corporation January 1998 - February 2000
Skills
CAPA, FDA, Manufacturing, Quality Auditing, Auditing, MedWatch Reporting, QSMR, Safety Review, Monthly Trending of..., ADR/MDR, BfArM, Quality System, Validation, Quality Assurance, Regulatory Affairs, GLP, Quality Control, Cross-functional Team..., Medical Devices, Quality Management, ISO, Software Documentation, Process Improvement, Continuous Improvement, V&V, 21 CFR Part 11, GxP, Change Control, GMP, Pharmaceutical Industry, Biotechnology, ISO 13485, TrackWise
Education
University of Illinois at Chicago 1988 — 1992
Bachelors of Science, Biological Sciences
Fashion Institute of Design & Merchandising 2006 — 2007
Associate of Arts, Merchandise Product Development
DePuy Synthes - Johnson and Johnson August 2014 - Present
MAETRICS March 2014 - June 2014
Medtronic October 2013 - February 2014
Exel September 2012 - September 2013
Ortho Clinical Diagnostics April 2011 - August 2012
Merck November 2009 - April 2011
Amgen July 2003 - September 2006
Immunex May 2000 - July 2003
Pharmacia February 2000 - May 2001
Home Access Health Corporation January 1998 - February 2000
Skills
CAPA, FDA, Manufacturing, Quality Auditing, Auditing, MedWatch Reporting, QSMR, Safety Review, Monthly Trending of..., ADR/MDR, BfArM, Quality System, Validation, Quality Assurance, Regulatory Affairs, GLP, Quality Control, Cross-functional Team..., Medical Devices, Quality Management, ISO, Software Documentation, Process Improvement, Continuous Improvement, V&V, 21 CFR Part 11, GxP, Change Control, GMP, Pharmaceutical Industry, Biotechnology, ISO 13485, TrackWise
Education
University of Illinois at Chicago 1988 — 1992
Bachelors of Science, Biological Sciences
Fashion Institute of Design & Merchandising 2006 — 2007
Associate of Arts, Merchandise Product Development
Adam Carman's MAETRICS Experience August 2008 - Present
Job Maetrics LLC
Industry Biotechnology
Experience
Maetrics August 2008 - Present
Boston Scientific 2006 - 2008
Ball Systems May 2005 - December 2006
Skills
ISO 13485, V&V, Medical Devices, Minitab, Design Control, Design of Experiments, ISO 14971, CAPA, FMEA, FDA, Validation, Quality System, DMAIC, Biomedical Engineering, Design for Manufacturing
Education
Indiana State University 2007 — 2010
BS, Mechanical Engineering Technology
Indiana State University 2002 — 2006
BS, Electronics and Computer Engineering Technlology
Maetrics August 2008 - Present
Boston Scientific 2006 - 2008
Ball Systems May 2005 - December 2006
Skills
ISO 13485, V&V, Medical Devices, Minitab, Design Control, Design of Experiments, ISO 14971, CAPA, FMEA, FDA, Validation, Quality System, DMAIC, Biomedical Engineering, Design for Manufacturing
Education
Indiana State University 2007 — 2010
BS, Mechanical Engineering Technology
Indiana State University 2002 — 2006
BS, Electronics and Computer Engineering Technlology
Keith Duncan's MAETRICS Experience September 2012 - May 2014
Job Medical Device Consultant & Contractor
Industry Medical Devices
Experience
Oxford International June 2014 - April 2015
MAETRICS September 2012 - May 2014
MAETRICS May 2014 - 2014
Oxford Global Resources February 2012 - May 2012
Oxford Global Resources September 2011 - November 2011
Validant September 2010 - July 2011
ConMed Linvatec 2003 - May 2009
Skills
Quality Assurance, Manufacturing, Risk Management, Microsoft Office, ISO 13485, CAPA, Design Control, Product Complaints, ISO 14971, FDA QSR, ASQ CQA, FDA GMP, FMEA, GD&T, Gage R&R, Lean Six Sigma, Six Sigma, Supplier Audit, ISO 9001, Minitab, Lean Manufacturing, Iso 9000, Auditing, FDA, Medical Devices, Quality System, Quality Control, V, Quality Auditing, Root Cause Analysis, Continuous Improvement, Validation, GMP, Process Improvement, Design of Experiments, DMAIC
Education
St. Petersburg College 2012 — 2012
St. Petersburg College 2009 — 2010
Certificate, Six Sigma Black Belt
St. Petersburg College 2009 — 2010
Certificate, Lean Six Sigma Green Belt
St. Petersburg College 2009 — 2010
Certificate, Linux System Administrator
University of South Florida 2001 — 2003
BA, Management Information Systems
St. Petersburg College 1997 — 2000
AA
Tampa Technical Institute 1987 — 1990
BSCET, Computer Engineering Technology
Oxford International June 2014 - April 2015
MAETRICS September 2012 - May 2014
MAETRICS May 2014 - 2014
Oxford Global Resources February 2012 - May 2012
Oxford Global Resources September 2011 - November 2011
Validant September 2010 - July 2011
ConMed Linvatec 2003 - May 2009
Skills
Quality Assurance, Manufacturing, Risk Management, Microsoft Office, ISO 13485, CAPA, Design Control, Product Complaints, ISO 14971, FDA QSR, ASQ CQA, FDA GMP, FMEA, GD&T, Gage R&R, Lean Six Sigma, Six Sigma, Supplier Audit, ISO 9001, Minitab, Lean Manufacturing, Iso 9000, Auditing, FDA, Medical Devices, Quality System, Quality Control, V, Quality Auditing, Root Cause Analysis, Continuous Improvement, Validation, GMP, Process Improvement, Design of Experiments, DMAIC
Education
St. Petersburg College 2012 — 2012
St. Petersburg College 2009 — 2010
Certificate, Six Sigma Black Belt
St. Petersburg College 2009 — 2010
Certificate, Lean Six Sigma Green Belt
St. Petersburg College 2009 — 2010
Certificate, Linux System Administrator
University of South Florida 2001 — 2003
BA, Management Information Systems
St. Petersburg College 1997 — 2000
AA
Tampa Technical Institute 1987 — 1990
BSCET, Computer Engineering Technology
Kathy Haber's MAETRICS Experience 2013 - 2014
Job Document Control Specialist at Integra LifeSciences
Industry Pharmaceuticals
Experience
Integra LifeSciences 2015 - Present
Gorilla Glue Company May 2013 - Present
MAETRICS 2013 - 2014
Integra LifeScience April 2013 - May 2013
Schulman Associates IRB, Inc. August 2012 - January 2013
Mammotome November 2010 - May 2012
Hartz Mountain Corporation July 2010 - November 2010
Patheon February 2005 - July 2009
Skills
FDA, Sop, Quality System, Pharmaceutical Industry, Quality Assurance, Data Analysis, Design History Files -...
Education
University of Cincinnati 1976 — 1978
AS, Chemistry-Biology
Integra LifeSciences 2015 - Present
Gorilla Glue Company May 2013 - Present
MAETRICS 2013 - 2014
Integra LifeScience April 2013 - May 2013
Schulman Associates IRB, Inc. August 2012 - January 2013
Mammotome November 2010 - May 2012
Hartz Mountain Corporation July 2010 - November 2010
Patheon February 2005 - July 2009
Skills
FDA, Sop, Quality System, Pharmaceutical Industry, Quality Assurance, Data Analysis, Design History Files -...
Education
University of Cincinnati 1976 — 1978
AS, Chemistry-Biology
Linda Redner's MAETRICS Experience July 2013 - June 2014
Job Creative, Experienced Computer Systems QA/Validation Engineer
Industry Computer Software
Experience
MAETRICS July 2013 - June 2014
JBL Resources March 2013 - July 2013
Automated Systems, Inc. August 2012 - October 2012
TEKsystems January 2012 - June 2012
CardinalHealth January 2010 - January 2012
Abbott September 2000 - March 2009
Skills
Validation, SDLC, Compliance, Quality Assurance, Quality System, GxP, Software Documentation, GMP, Testing, Process Improvement, Cross-functional Team..., FDA, 21 CFR Part 11, V&V, Change Control, Pharmaceutical Industry, Medical Devices, Computer System..., Sop, Regulatory Affairs, CAPA, SOP
Education
Northeastern Illinois University 1991 — 1992
Bachelor of Arts (BA), Design
MAETRICS July 2013 - June 2014
JBL Resources March 2013 - July 2013
Automated Systems, Inc. August 2012 - October 2012
TEKsystems January 2012 - June 2012
CardinalHealth January 2010 - January 2012
Abbott September 2000 - March 2009
Skills
Validation, SDLC, Compliance, Quality Assurance, Quality System, GxP, Software Documentation, GMP, Testing, Process Improvement, Cross-functional Team..., FDA, 21 CFR Part 11, V&V, Change Control, Pharmaceutical Industry, Medical Devices, Computer System..., Sop, Regulatory Affairs, CAPA, SOP
Education
Northeastern Illinois University 1991 — 1992
Bachelor of Arts (BA), Design
Bruce Corwin's MAETRICS Experience January 2015 - Present
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
Frances (Frankie) Soliven-Meglin's MAETRICS Experience 2014 - 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)
Sonia N Gonzalez's MAETRICS Experience April 2014 - October 2014
Job Product Quality Engineer at QualComp Technical Services
Industry Medical Devices
Experience
QualComp Technical Services March 2015 - August 2015
MAETRICS April 2014 - October 2014
Medtronic February 2008 - April 2011
Medtronic March 2000 - February 2008
Skills
ISO 13485, QSR, CAPA, Quality Systems, 21 CFR Part 11, Quality System, Quality Auditing, Medical Devices, FDA, Cross-functional Team..., Design of Experiments, Lean Manufacturing, ISO, FMEA, Auditing, V&V, Manufacturing, ISO 14971, Pharmaceutical Industry, DMAIC, Validation, Process Improvement, R&D, SPC, Employee Training, Continuous Improvement, Human Resources, Root Cause Analysis, Supplier Quality, Testing, GMP, Quality Management, Process Simulation, Regulatory Requirements, Sop, Six Sigma, Minitab, Design Control, Software Documentation, Quality Control, Quality Assurance, Training, Change Control, Regulatory Affairs, GxP, Iso 9000, Manufacturing Operations, 5S, Kaizen, Value Stream Mapping
Education
Columbia Centro Universitario-Caguas 2004 — 2005
Master, Business Administration
Columbia Centro Universitario-Caguas 2000 — 2002
Bachelor, Business Administration
Columbia Centro Universitario-Caguas 2000 — 2002
Associate's degree, Business Administration in Information Systems, Associate
QualComp Technical Services March 2015 - August 2015
MAETRICS April 2014 - October 2014
Medtronic February 2008 - April 2011
Medtronic March 2000 - February 2008
Skills
ISO 13485, QSR, CAPA, Quality Systems, 21 CFR Part 11, Quality System, Quality Auditing, Medical Devices, FDA, Cross-functional Team..., Design of Experiments, Lean Manufacturing, ISO, FMEA, Auditing, V&V, Manufacturing, ISO 14971, Pharmaceutical Industry, DMAIC, Validation, Process Improvement, R&D, SPC, Employee Training, Continuous Improvement, Human Resources, Root Cause Analysis, Supplier Quality, Testing, GMP, Quality Management, Process Simulation, Regulatory Requirements, Sop, Six Sigma, Minitab, Design Control, Software Documentation, Quality Control, Quality Assurance, Training, Change Control, Regulatory Affairs, GxP, Iso 9000, Manufacturing Operations, 5S, Kaizen, Value Stream Mapping
Education
Columbia Centro Universitario-Caguas 2004 — 2005
Master, Business Administration
Columbia Centro Universitario-Caguas 2000 — 2002
Bachelor, Business Administration
Columbia Centro Universitario-Caguas 2000 — 2002
Associate's degree, Business Administration in Information Systems, Associate
Afra Anane's MAETRICS Experience 2013 - 2014
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
Malisa Rakanovic's MAETRICS Experience March 2014 - July 2014
Job Quality Professional
Industry Pharmaceuticals
Experience
AbbVie July 2014 - Present
MAETRICS March 2014 - July 2014
Hospira March 2013 - March 2014
Baxter Healthcare January 2012 - March 2013
Baxter International Inc. September 2011 - December 2011
Nestle S.A. July 2011 - August 2011
Intertek April 2011 - June 2011
Illinois Institute of Technology October 2009 - August 2010
Dow Automotive Systems October 2006 - November 2007
Basha Diagnostics, P.C. May 2005 - July 2006
Skills
FDA, Medical Devices, CAPA, Quality System, Quality Assurance, Regulatory Affairs, GMP, Quality Control, Process Simulation, Change Control, ISO 13485, Biomedical Engineering, SOP, Cross-functional Team...
Education
Illinois Institute of Technology 2008 — 2010
B.S., Chemical Engineering
AbbVie July 2014 - Present
MAETRICS March 2014 - July 2014
Hospira March 2013 - March 2014
Baxter Healthcare January 2012 - March 2013
Baxter International Inc. September 2011 - December 2011
Nestle S.A. July 2011 - August 2011
Intertek April 2011 - June 2011
Illinois Institute of Technology October 2009 - August 2010
Dow Automotive Systems October 2006 - November 2007
Basha Diagnostics, P.C. May 2005 - July 2006
Skills
FDA, Medical Devices, CAPA, Quality System, Quality Assurance, Regulatory Affairs, GMP, Quality Control, Process Simulation, Change Control, ISO 13485, Biomedical Engineering, SOP, Cross-functional Team...
Education
Illinois Institute of Technology 2008 — 2010
B.S., Chemical Engineering
Carol Grobe's MAETRICS Experience May 2015 - Present
Job Quality Consultant at American Medical Supplies Inc
Industry Medical Devices
Experience
MAETRICS May 2015 - Present
MAETRICS January 2015 - April 2015
MAETRICS June 2013 - December 2014
Validant April 2011 - May 2013
bioMerieux 2009 - 2010
bioMerieux December 2002 - December 2009
Medtronic Midas Rex 2000 - 2002
CR Bard 1998 - 2000
Skills
ISO 13485, Quality System, Medical Devices, Quality Assurance, Iso 9000, Software Documentation, FDA, Change Control, Quality Control, Process Improvement, CAPA, GMP, Technical Writing, Root Cause Analysis, ISO, Document Management, Validation, Design Control, Engineering, V&V, ISO 9000
Education
Montreat College 1997 — 1999
MBA, Business Administration and Management, General
Clemson University 1981 — 1986
BS, Mechanical Engineering
MAETRICS May 2015 - Present
MAETRICS January 2015 - April 2015
MAETRICS June 2013 - December 2014
Validant April 2011 - May 2013
bioMerieux 2009 - 2010
bioMerieux December 2002 - December 2009
Medtronic Midas Rex 2000 - 2002
CR Bard 1998 - 2000
Skills
ISO 13485, Quality System, Medical Devices, Quality Assurance, Iso 9000, Software Documentation, FDA, Change Control, Quality Control, Process Improvement, CAPA, GMP, Technical Writing, Root Cause Analysis, ISO, Document Management, Validation, Design Control, Engineering, V&V, ISO 9000
Education
Montreat College 1997 — 1999
MBA, Business Administration and Management, General
Clemson University 1981 — 1986
BS, Mechanical Engineering
Bridget Cull's MAETRICS Experience 2008 - 2009
Job Business Analyst / Technical Writer
Industry Insurance
Experience
BCforward February 2015 - Present
ACS / Xerox March 2014 - August 2014
BCforward (@Xerox and Eli Lilly) August 2009 - February 2014
Maetrics 2008 - 2009
Eliassen Group 2004 - 2006
CTG 2004 - 2006
Analysts International Corporation (AIC) July 2002 - May 2004
Humana January 1995 - June 2002
Skills
SDLC, Technical Writing, Software Documentation, Computer System..., Vendor Management, Business Analysis, Health Insurance, Organization, Communication, Project Coordination, Customer Service, Supervisory Experience, Requirements Gathering, Process Improvement, Software Project..., Requirements Analysis, SharePoint, Visio, Project Management, Training, 21 CFR Part 11, CAPA, GxP, Test Planning
Education
University of Kentucky 1979 — 1980
Bachelor of Arts (BA), Journalism
University of Louisville 1975 — 1978
BCforward February 2015 - Present
ACS / Xerox March 2014 - August 2014
BCforward (@Xerox and Eli Lilly) August 2009 - February 2014
Maetrics 2008 - 2009
Eliassen Group 2004 - 2006
CTG 2004 - 2006
Analysts International Corporation (AIC) July 2002 - May 2004
Humana January 1995 - June 2002
Skills
SDLC, Technical Writing, Software Documentation, Computer System..., Vendor Management, Business Analysis, Health Insurance, Organization, Communication, Project Coordination, Customer Service, Supervisory Experience, Requirements Gathering, Process Improvement, Software Project..., Requirements Analysis, SharePoint, Visio, Project Management, Training, 21 CFR Part 11, CAPA, GxP, Test Planning
Education
University of Kentucky 1979 — 1980
Bachelor of Arts (BA), Journalism
University of Louisville 1975 — 1978
Andy Grom's MAETRICS Experience 2007 - 2008
Job Quality and Compliance Professional
Industry Medical Devices
Experience
Cardiac Scinces Inc June 2012 - July 2015
Cardiac Science Inc June 2014 - January 2015
Baxter International Inc. May 2011 - June 2012
MAETRICS 2007 - 2008
MAETRICS 2007 - 2008
Skills
Qaulity Systems, FDA, Supplier Quality, Manufacturing Operations, Document Management, Quality Engineering, ISO 13485, ISO 9001, Audting, Quality System, CAPA, Quality Auditing, Quality Assurance, Validation, GMP, Quality Management, ISO, Root Cause Analysis, V&V, Six Sigma, FMEA, Medical Devices, Change Control, DMAIC, SOP, SPC, Continuous Improvement, 21 CFR Part 11, Manufacturing
Education
The University of Kansas
Bachelor of Arts (B.A.)
Cardiac Scinces Inc June 2012 - July 2015
Cardiac Science Inc June 2014 - January 2015
Baxter International Inc. May 2011 - June 2012
MAETRICS 2007 - 2008
MAETRICS 2007 - 2008
Skills
Qaulity Systems, FDA, Supplier Quality, Manufacturing Operations, Document Management, Quality Engineering, ISO 13485, ISO 9001, Audting, Quality System, CAPA, Quality Auditing, Quality Assurance, Validation, GMP, Quality Management, ISO, Root Cause Analysis, V&V, Six Sigma, FMEA, Medical Devices, Change Control, DMAIC, SOP, SPC, Continuous Improvement, 21 CFR Part 11, Manufacturing
Education
The University of Kansas
Bachelor of Arts (B.A.)
Deloitte
PwC
Ernst & Young
Walgreens
Procter & Gamble
KPMG
PricewaterhouseCoopers
EY