Maetrics, LLC
Industry: Company
DescriptionFounded: 1984 Subsidiary: Maetrics Ltd.
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Maetrics, LLC Employees
Employee
Years
Job
Industry
Barbara Sommer Barbara Sommer's Maetrics, LLC Experience April 2013 - February 2015
Job Compliance and Quality Consultant at Redbock
Industry Medical Devices
Experience
Redbock August 2015 - Present
Maetrics, LLC April 2013 - February 2015
Stryker 2008 - 2011
Jenny Craig November 2007 - November 2008
Lindamood-Bell Learning Processes June 2006 - February 2007
Skills
Medical Devices, Customer Service, Quality Assurance, FDA, Cross-functional Team..., Regulatory Affairs, Quality System, Training, Data Analysis, Microsoft Office, CAPA, Process Improvement, Strategic Planning, Healthcare, Sales, Quality Management, Research, Complaint Management, MDRs, Post Market Surveillance
Education
University of California, Davis
BA, Communications
Redbock August 2015 - Present
Maetrics, LLC April 2013 - February 2015
Stryker 2008 - 2011
Jenny Craig November 2007 - November 2008
Lindamood-Bell Learning Processes June 2006 - February 2007
Skills
Medical Devices, Customer Service, Quality Assurance, FDA, Cross-functional Team..., Regulatory Affairs, Quality System, Training, Data Analysis, Microsoft Office, CAPA, Process Improvement, Strategic Planning, Healthcare, Sales, Quality Management, Research, Complaint Management, MDRs, Post Market Surveillance
Education
University of California, Davis
BA, Communications
Vernetta Meyers Vernetta Meyers's Maetrics, LLC Experience May 2013 - December 2014
Job Compliance & Quality Manager
Industry Management Consulting
Experience
VMI Office Solutions March 2015 - Present
Maetrics, LLC May 2013 - December 2014
Eli Lilly and Company (Formally Monsanto Company) June 2011 - May 2013
Eli Lilly and Company (Formally Monsanto Company) February 2010 - June 2011
Eli Lilly and Company (Formally Monsanto Company) June 2008 - February 2010
Monsanto Company December 2004 - December 2007
Monsanto Company September 2002 - December 2004
Monsanto Company September 2001 - September 2002
Skills
CAPA, Quality Assurance, FDA, Change Control, Validation, GMP, Medical Devices, Computer System..., 21 CFR Part 11, Quality Auditing, SOP, Complaint Management, LIMS, Complaint Investigations, GxP, SAP R/3, Trackwise, Batch Records, GAMP, GLP, Pharmaceutical Industry, ISO 9001, Batch Release, External Audit, Internal Audit, Recalls, MDRs, eMDR, Quality System, ISO 13485, Biotechnology, Regulatory Affairs, Process Improvement, EtQ
Education
University of Phoenix
VMI Office Solutions March 2015 - Present
Maetrics, LLC May 2013 - December 2014
Eli Lilly and Company (Formally Monsanto Company) June 2011 - May 2013
Eli Lilly and Company (Formally Monsanto Company) February 2010 - June 2011
Eli Lilly and Company (Formally Monsanto Company) June 2008 - February 2010
Monsanto Company December 2004 - December 2007
Monsanto Company September 2002 - December 2004
Monsanto Company September 2001 - September 2002
Skills
CAPA, Quality Assurance, FDA, Change Control, Validation, GMP, Medical Devices, Computer System..., 21 CFR Part 11, Quality Auditing, SOP, Complaint Management, LIMS, Complaint Investigations, GxP, SAP R/3, Trackwise, Batch Records, GAMP, GLP, Pharmaceutical Industry, ISO 9001, Batch Release, External Audit, Internal Audit, Recalls, MDRs, eMDR, Quality System, ISO 13485, Biotechnology, Regulatory Affairs, Process Improvement, EtQ
Education
University of Phoenix
Nancy Zhou Nancy Zhou's Maetrics, LLC Experience May 2013 - July 2014
Job Quality Engineer at Thermo Fisher Scientific (Life Technologies)
Industry Medical Devices
Experience
Thermo Fisher Scientific (Life Technologies) July 2014 - Present
Maetrics, LLC May 2013 - July 2014
Teco Diagnostics January 2012 - April 2013
Teco Diagnostics July 2011 - November 2011
Teco Diagnostics August 2008 - July 2011
UC San Diego March 2006 - June 2008
Skills
ISO 13485, FDA, GMP, Design Control, Validation, Medical Devices, CAPA, Quality Assurance, Regulatory Affairs, Complaints, Quality System, MDR, Biotechnology, GLP, Customer Service, Lifesciences, Trackwise, Microsoft Office, Syspro, SAP, JDE Enterprise One, Life Sciences, V
Education
UCSD 2004 — 2008
Bachelor of Science (BS), Bioengineering: Biotechnology
Thermo Fisher Scientific (Life Technologies) July 2014 - Present
Maetrics, LLC May 2013 - July 2014
Teco Diagnostics January 2012 - April 2013
Teco Diagnostics July 2011 - November 2011
Teco Diagnostics August 2008 - July 2011
UC San Diego March 2006 - June 2008
Skills
ISO 13485, FDA, GMP, Design Control, Validation, Medical Devices, CAPA, Quality Assurance, Regulatory Affairs, Complaints, Quality System, MDR, Biotechnology, GLP, Customer Service, Lifesciences, Trackwise, Microsoft Office, Syspro, SAP, JDE Enterprise One, Life Sciences, V
Education
UCSD 2004 — 2008
Bachelor of Science (BS), Bioengineering: Biotechnology
Tina Lochner Tina Lochner's Maetrics, LLC Experience October 2013 - 2014
Job President at MEDCERTUSA, LLC
Industry Medical Devices
Experience
MEDCERT-USA, LLC 2014 - Present
Maetrics, LLC October 2013 - 2014
Haemonetics Inc. August 2012 - September 2013
DEKRA Certification North America January 2011 - July 2012
TUV Rheinland of North America, Inc. & TUV Rheinland LGA Products GmbH September 2003 - December 2010
Abbott GmbH & Co October 2002 - August 2003
Across Barriers GmbH November 2001 - September 2002
EMC microcollections GmbH April 2001 - October 2001
biotex Hamburg April 2000 - March 2001
Skills
Iso 9000, FDA, Clinical Trials, ISO 13485, Molecular Biology, Quality System, Validation, R&D, GMP, Biotechnology, Lifesciences, Medical Devices, Cell Culture, GLP, CAPA, Pharmaceutical Industry, V&V, 21 CFR Part 11, Professional..., Quality Auditing, Software Documentation, Quality Assurance, Regulatory Affairs, Design Control, Regulatory Submissions, Quality Management, Quality Control, Cross-functional Team..., Six Sigma, Regulatory Requirements, Design of Experiments, ISO, Laboratory, Biomedical Engineering, ISO 14971, Change Control, FMEA, Sop
Education
University of Maryland University College 2008 — 2009
Master, Business Administration
University of Maryland University College 2003 — 2007
Master of Science, Biotechnology
Hamburg University of Applied Sciences 1995 — 2001
Bachelor of Engineering, Biotechnology
Elsa-Braendstroem Gymnasium Elmshorn 1983 — 1992
A-levels, Biology and English
MEDCERT-USA, LLC 2014 - Present
Maetrics, LLC October 2013 - 2014
Haemonetics Inc. August 2012 - September 2013
DEKRA Certification North America January 2011 - July 2012
TUV Rheinland of North America, Inc. & TUV Rheinland LGA Products GmbH September 2003 - December 2010
Abbott GmbH & Co October 2002 - August 2003
Across Barriers GmbH November 2001 - September 2002
EMC microcollections GmbH April 2001 - October 2001
biotex Hamburg April 2000 - March 2001
Skills
Iso 9000, FDA, Clinical Trials, ISO 13485, Molecular Biology, Quality System, Validation, R&D, GMP, Biotechnology, Lifesciences, Medical Devices, Cell Culture, GLP, CAPA, Pharmaceutical Industry, V&V, 21 CFR Part 11, Professional..., Quality Auditing, Software Documentation, Quality Assurance, Regulatory Affairs, Design Control, Regulatory Submissions, Quality Management, Quality Control, Cross-functional Team..., Six Sigma, Regulatory Requirements, Design of Experiments, ISO, Laboratory, Biomedical Engineering, ISO 14971, Change Control, FMEA, Sop
Education
University of Maryland University College 2008 — 2009
Master, Business Administration
University of Maryland University College 2003 — 2007
Master of Science, Biotechnology
Hamburg University of Applied Sciences 1995 — 2001
Bachelor of Engineering, Biotechnology
Elsa-Braendstroem Gymnasium Elmshorn 1983 — 1992
A-levels, Biology and English
Samuel C. Nelson Samuel C. Nelson's Maetrics, LLC Experience February 2013 - February 2015
Job 8 years of Quality and Regulatory Experience in Medical Devices
Industry Medical Devices
Experience
Maetrics, LLC February 2013 - February 2015
Proctor U October 2012 - February 2013
McWane Science Center October 1998 - February 2013
BioHorizons Implant Systems, Inc August 2009 - July 2012
BioHorizons Implant Systems, Inc July 2008 - August 2009
BioHorizons Implant Systems, Inc September 2007 - July 2008
Skills
FDA, Medical Devices, Quality System, Quality Assurance, GMP, Microsoft Office, Regulatory Affairs, Museum Education, Marine Biology, Informal Education, Quality Auditing, Quality Control, Research, Software Documentation, Customer Service, Quality Management, Science, Process Improvement, 21 CFR Part 11, Education, Creative Writing, Museums
Education
University of Montevallo 2001 — 2007
Bachelor of Science (B.S.), Biology/Biological Sciences, General
Maetrics, LLC February 2013 - February 2015
Proctor U October 2012 - February 2013
McWane Science Center October 1998 - February 2013
BioHorizons Implant Systems, Inc August 2009 - July 2012
BioHorizons Implant Systems, Inc July 2008 - August 2009
BioHorizons Implant Systems, Inc September 2007 - July 2008
Skills
FDA, Medical Devices, Quality System, Quality Assurance, GMP, Microsoft Office, Regulatory Affairs, Museum Education, Marine Biology, Informal Education, Quality Auditing, Quality Control, Research, Software Documentation, Customer Service, Quality Management, Science, Process Improvement, 21 CFR Part 11, Education, Creative Writing, Museums
Education
University of Montevallo 2001 — 2007
Bachelor of Science (B.S.), Biology/Biological Sciences, General
Shital Patel Shital Patel's Maetrics, LLC Experience August 2006 - July 2011
Job Engineering Consultant at Enhanced Compliance Inc.
Industry Medical Devices
Experience
Enhanced Compliance Inc July 2011 - Present
Boston Scientific August 2006 - Present
Maetrics LLC August 2006 - July 2011
Dentsply Pharmaceuticals December 2005 - August 2006
Abbott Laboratories February 2001 - December 2005
Skills
Design Control, CAPA, ISO 13485, V&V, Medical Devices, Process Improvement, Validation, Process Engineering, Test Methodologies, Minitab, Pharmaceutical Industry, Project Engineering, Project Management, Quality Assurance, Medical Device Directive, ISO 14971, Design Verification..., P&ID, Water Systems, Complaint Investigations, Product Complaints, 21 CFR Part 11, Root Cause Analysis, Gage R&R, QSR, SOP authoring, cGMP manufacturing, cGMP practices, Quality Control, Quality System, Standards Compliance, Risk Management, Change Control, GAMP, GMP, Design of Experiments, Computer System..., FDA
Education
University of Illinois at Urbana-Champaign 1995 — 2000
Bachelor of Science, BioEngineering
Enhanced Compliance Inc July 2011 - Present
Boston Scientific August 2006 - Present
Maetrics LLC August 2006 - July 2011
Dentsply Pharmaceuticals December 2005 - August 2006
Abbott Laboratories February 2001 - December 2005
Skills
Design Control, CAPA, ISO 13485, V&V, Medical Devices, Process Improvement, Validation, Process Engineering, Test Methodologies, Minitab, Pharmaceutical Industry, Project Engineering, Project Management, Quality Assurance, Medical Device Directive, ISO 14971, Design Verification..., P&ID, Water Systems, Complaint Investigations, Product Complaints, 21 CFR Part 11, Root Cause Analysis, Gage R&R, QSR, SOP authoring, cGMP manufacturing, cGMP practices, Quality Control, Quality System, Standards Compliance, Risk Management, Change Control, GAMP, GMP, Design of Experiments, Computer System..., FDA
Education
University of Illinois at Urbana-Champaign 1995 — 2000
Bachelor of Science, BioEngineering
Kate Hazelwood Kate Hazelwood's Maetrics, LLC Experience November 2012 - April 2014
Job Regulatory Coordinator
Industry Pharmaceuticals
Experience
Meridien Research August 2014 - Present
Meridien Research June 2014 - August 2014
Maetrics, LLC November 2012 - April 2014
Stryker Sustainability Solutions October 2008 - September 2011
CVS Pharmacy March 2008 - September 2008
Skills
FDA, Medical Devices, ISO 13485, Validation, V&V, GMP, CAPA, Quality System, Quality Assurance, Quality Auditing, Minitab, Product Launch, Cross-functional Team..., Six Sigma, R&D, Quality Management, ISO, Hospitals, Pharmaceutical Industry, Lean Manufacturing, Continuous Improvement, Manufacturing, Design Control, Sop, 21 CFR Part 11, Supplier Quality, Value Stream Mapping, Change Control, Quality Control
Education
University of Central Florida 2005 — 2007
Bachelors of Science, Biomedical Sciences
University of Florida 2003 — 2005
Pre-Pharmacy
Meridien Research August 2014 - Present
Meridien Research June 2014 - August 2014
Maetrics, LLC November 2012 - April 2014
Stryker Sustainability Solutions October 2008 - September 2011
CVS Pharmacy March 2008 - September 2008
Skills
FDA, Medical Devices, ISO 13485, Validation, V&V, GMP, CAPA, Quality System, Quality Assurance, Quality Auditing, Minitab, Product Launch, Cross-functional Team..., Six Sigma, R&D, Quality Management, ISO, Hospitals, Pharmaceutical Industry, Lean Manufacturing, Continuous Improvement, Manufacturing, Design Control, Sop, 21 CFR Part 11, Supplier Quality, Value Stream Mapping, Change Control, Quality Control
Education
University of Central Florida 2005 — 2007
Bachelors of Science, Biomedical Sciences
University of Florida 2003 — 2005
Pre-Pharmacy
Martin Rubin Martin Rubin's Maetrics, LLC Experience October 2012 - January 2013
Job Medical Devices QA/Regulatory Engineer
Industry Medical Devices
Experience
Adepta Sport Technologies March 2011 - Present
Actively Pursuing New Opportunities Throughout New Jersey December 2009 - Present
Sirona Dental, Inc. January 2013 - July 2013
Maetrics, LLC October 2012 - January 2013
Ellman International October 2010 - March 2011
Dentsply Tulsa Dental Specialties July 2006 - March 2009
Applied Optronics Corp. January 1995 - June 2006
AOC Medical Systems 1995 - 2002
Carl Zeiss, Inc. August 1991 - December 1994
Laser Industries, Ltd. 1979 - 1984
Skills
Medical Devices, Product Development, Project Management, Engineering, FDA, Six Sigma, Process Engineering, Black Belts, DMAIC, DFSS, QFD, House of Quality, Validation, Quality Assurance, Process Improvement, Team Building, Electronics, Training, ISO, Leadership, R&D, Software Documentation, Testing, Quality System, Manufacturing, Management, Cross-functional Team...
Education
University of Phoenix, Tulsa Campus 2007 — 2009
MBA, Business Administration
University of Rochester 1973 — 1977
BSEE, Electrical Engineering
Adepta Sport Technologies March 2011 - Present
Actively Pursuing New Opportunities Throughout New Jersey December 2009 - Present
Sirona Dental, Inc. January 2013 - July 2013
Maetrics, LLC October 2012 - January 2013
Ellman International October 2010 - March 2011
Dentsply Tulsa Dental Specialties July 2006 - March 2009
Applied Optronics Corp. January 1995 - June 2006
AOC Medical Systems 1995 - 2002
Carl Zeiss, Inc. August 1991 - December 1994
Laser Industries, Ltd. 1979 - 1984
Skills
Medical Devices, Product Development, Project Management, Engineering, FDA, Six Sigma, Process Engineering, Black Belts, DMAIC, DFSS, QFD, House of Quality, Validation, Quality Assurance, Process Improvement, Team Building, Electronics, Training, ISO, Leadership, R&D, Software Documentation, Testing, Quality System, Manufacturing, Management, Cross-functional Team...
Education
University of Phoenix, Tulsa Campus 2007 — 2009
MBA, Business Administration
University of Rochester 1973 — 1977
BSEE, Electrical Engineering
Maritza Zayas BSEE, MBA Maritza Zayas BSEE, MBA's Maetrics, LLC Experience March 2013 - November 2013
Job GMP and NCR Subject Matter Expert at Quality Consulting Group, Inc
Industry Medical Devices
Experience
Quality Consulting Group, Inc March 2015 - Present
QualityHub, Inc. May 2014 - February 2015
Quality Consulting Group, Inc December 2013 - May 2014
Maetrics, LLC March 2013 - November 2013
Business Excellence Consulting November 2012 - March 2013
Covidien March 2011 - November 2012
Covidien February 2010 - February 2011
Becton Dickinson February 2007 - October 2009
Northrop Grumman Corporation June 1987 - February 2007
Northrop Grumman Corporation June 1987 - February 2007
Skills
Strategic Planning, Manufacturing, Quality System, AS9100, FMEA, Six Sigma, Cross-functional Team..., Minitab, Electronics, Black Belt, Kaizen, 5S, Validation, Team Building, Problem Solving, DMAIC, Supplier Quality, Iso 9000, Manufacturing Operations, Engineering Management, FDA, Root Cause Analysis, Continuous Improvement, Quality Auditing, Quality Management, Corrective Actions, Value Stream Mapping, Team Leadership, Quality Control, SPC, Design of Experiments, Medical Devices, CAPA, ISO 13485, V&V, ISO, Design Control, Change Control, Manufacturing..., ISO 14971, Quality Assurance, Green Belt, Process Capability, Calibration, TQM, GMP, Manufacturing..., 21 CFR Part 11, FDA GMP, Supplier Quality...
Education
University of Phoenix 2002 — 2004
Master of Business Administration (M.B.A.), Technology Management
University of Puerto Rico-Mayaguez 1981 — 1986
Bachelor of Science (B.S.), Electrical and Electronics Engineering
Quality Consulting Group, Inc March 2015 - Present
QualityHub, Inc. May 2014 - February 2015
Quality Consulting Group, Inc December 2013 - May 2014
Maetrics, LLC March 2013 - November 2013
Business Excellence Consulting November 2012 - March 2013
Covidien March 2011 - November 2012
Covidien February 2010 - February 2011
Becton Dickinson February 2007 - October 2009
Northrop Grumman Corporation June 1987 - February 2007
Northrop Grumman Corporation June 1987 - February 2007
Skills
Strategic Planning, Manufacturing, Quality System, AS9100, FMEA, Six Sigma, Cross-functional Team..., Minitab, Electronics, Black Belt, Kaizen, 5S, Validation, Team Building, Problem Solving, DMAIC, Supplier Quality, Iso 9000, Manufacturing Operations, Engineering Management, FDA, Root Cause Analysis, Continuous Improvement, Quality Auditing, Quality Management, Corrective Actions, Value Stream Mapping, Team Leadership, Quality Control, SPC, Design of Experiments, Medical Devices, CAPA, ISO 13485, V&V, ISO, Design Control, Change Control, Manufacturing..., ISO 14971, Quality Assurance, Green Belt, Process Capability, Calibration, TQM, GMP, Manufacturing..., 21 CFR Part 11, FDA GMP, Supplier Quality...
Education
University of Phoenix 2002 — 2004
Master of Business Administration (M.B.A.), Technology Management
University of Puerto Rico-Mayaguez 1981 — 1986
Bachelor of Science (B.S.), Electrical and Electronics Engineering
ERICA DIAZ, MS ERICA DIAZ, MS's Maetrics, LLC Experience April 2013 - December 2014
Job REGULATORY AFFAIRS SPECIALIST
Industry Medical Devices
Experience
Edwards Lifesciences December 2014 - Present
Maetrics, LLC April 2013 - December 2014
Haemonetics September 2011 - March 2013
Southwood Pharmaceuticals, Inc. 2009 - 2011
Skills
FDA, Medical Devices, Design Control, CAPA, Regulatory Affairs, Regulatory Submissions, CE marking, V&V, Quality System, Validation, GMP, Regulatory Requirements, 21 CFR, FDA GMP, Post Market Surveillance, ISO 13485, Medical Device Directive, Advetising and Promotion, Recalls, 21 CFR Part 11, Change Control, ISO 14971
Education
Villanova University 2014 — 2016
Master of Business Administration (M.B.A.)
Northeastern University 2012 — 2013
Master of Science (M.S.), Regulatory Affairs for Drugs, Biologics and Medical Devices
UC Irvine
Bachelor's degree
Edwards Lifesciences December 2014 - Present
Maetrics, LLC April 2013 - December 2014
Haemonetics September 2011 - March 2013
Southwood Pharmaceuticals, Inc. 2009 - 2011
Skills
FDA, Medical Devices, Design Control, CAPA, Regulatory Affairs, Regulatory Submissions, CE marking, V&V, Quality System, Validation, GMP, Regulatory Requirements, 21 CFR, FDA GMP, Post Market Surveillance, ISO 13485, Medical Device Directive, Advetising and Promotion, Recalls, 21 CFR Part 11, Change Control, ISO 14971
Education
Villanova University 2014 — 2016
Master of Business Administration (M.B.A.)
Northeastern University 2012 — 2013
Master of Science (M.S.), Regulatory Affairs for Drugs, Biologics and Medical Devices
UC Irvine
Bachelor's degree
Monica Lozano's Maetrics, LLC Experience January 2013 - February 2015
Job Sr. Compliance and Quality Specialist for Medical Devices
Industry Medical Devices
Experience
CooperSurgical March 2015 - Present
Maetrics, LLC January 2013 - February 2015
Covidien December 2007 - June 2012
The Hartford November 2005 - December 2007
Travelers Life and Annuity May 2003 - November 2005
ING Americas (formerly Aetna Financial Services) November 2000 - July 2002
Aetna Financial Services September 1999 - October 2000
Aetna Financial Services June 1997 - September 1999
Aetna Financial Services October 1995 - June 1997
U.S. House of Representatives 1992 - 1994
Skills
Quality Assurance, FDA, Medical Devices, Cross-functional Team..., Access, ISO 13485, Quality System, CAPA, 21 CFR Part 11, Regulatory Compliance, Software Documentation, ISO 14971, Microsoft Excel, Microsoft Word, Validation, Complaint Investigations, PowerPoint, Surgical Instruments, Adverse Event Reporting, Post Market Surveillance, Visio, Design Control, V&V, Analysis, Data Analysis, Outlook, Lotus Notes, MS Project, SDLC, Organization, Communication, Troubleshooting, Project Management, Adobe Professional, VBA, SQL, ODBC, Adobe Acrobat, Cognos, Agile Project Management, Knowledge Base, Summit, Business Analysis, Crystal Reports, SAP, Microsoft Office, Process Improvement, Root Cause Analysis, cGMP practices
Education
University of Hartford 1995 — 2002
Bachelor of Science (BS), Legal Studies
CooperSurgical March 2015 - Present
Maetrics, LLC January 2013 - February 2015
Covidien December 2007 - June 2012
The Hartford November 2005 - December 2007
Travelers Life and Annuity May 2003 - November 2005
ING Americas (formerly Aetna Financial Services) November 2000 - July 2002
Aetna Financial Services September 1999 - October 2000
Aetna Financial Services June 1997 - September 1999
Aetna Financial Services October 1995 - June 1997
U.S. House of Representatives 1992 - 1994
Skills
Quality Assurance, FDA, Medical Devices, Cross-functional Team..., Access, ISO 13485, Quality System, CAPA, 21 CFR Part 11, Regulatory Compliance, Software Documentation, ISO 14971, Microsoft Excel, Microsoft Word, Validation, Complaint Investigations, PowerPoint, Surgical Instruments, Adverse Event Reporting, Post Market Surveillance, Visio, Design Control, V&V, Analysis, Data Analysis, Outlook, Lotus Notes, MS Project, SDLC, Organization, Communication, Troubleshooting, Project Management, Adobe Professional, VBA, SQL, ODBC, Adobe Acrobat, Cognos, Agile Project Management, Knowledge Base, Summit, Business Analysis, Crystal Reports, SAP, Microsoft Office, Process Improvement, Root Cause Analysis, cGMP practices
Education
University of Hartford 1995 — 2002
Bachelor of Science (BS), Legal Studies
Jessica Santos Jessica Santos's Maetrics, LLC Experience May 2013 - Present
Job Sr. Compliance & Quality Consultant / Subject Matter Expert
Industry Medical Devices
Experience
Maetrics, LLC May 2013 - Present
Coloplast March 2008 - Present
Acclarent 2015 - 2015
Acclarent 2015 - 2015
DePuy Orthopaedics 2013 - 2013
Boston Scientific October 2006 - December 2007
Boston Scientific 2006 - 2007
Guidant 2005 - 2006
Guidant 2004 - 2005
Guidant 2002 - 2003
Skills
Six Sigma, Technology Transfer, Medical Devices, ISO 13485, Quality Systems, Process Validation, FDA, CAPA, Lean Manufacturing, SPC, Validation, Quality Engineering, Continuous Improvement, ISO, Manufacturing, Design Control, FMEA, Quality Assurance, Minitab, Quality Management, GMP, DOE, DMAIC, Supplier Quality, Product Development, Engineering, Process Development, Process Improvement, Cross-functional Team..., R&D, Root Cause Analysis, Statistics, Supplier Management, Kaizen, Manufacturing Management, Risk Management, Compliance, Auditing, cGMP, QSR, Change Management, Design of Experiments, Documentation, Problem Solving, Quality System, V&V, Process Engineering, Manufacturing..., ISO 14971, 5S
Education
Interamerican University 1998 — 2003
MBA, Industrial Management
Universidad de Puerto Rico 1988 — 1993
BSME, Mechanical Engineering
Maetrics, LLC May 2013 - Present
Coloplast March 2008 - Present
Acclarent 2015 - 2015
Acclarent 2015 - 2015
DePuy Orthopaedics 2013 - 2013
Boston Scientific October 2006 - December 2007
Boston Scientific 2006 - 2007
Guidant 2005 - 2006
Guidant 2004 - 2005
Guidant 2002 - 2003
Skills
Six Sigma, Technology Transfer, Medical Devices, ISO 13485, Quality Systems, Process Validation, FDA, CAPA, Lean Manufacturing, SPC, Validation, Quality Engineering, Continuous Improvement, ISO, Manufacturing, Design Control, FMEA, Quality Assurance, Minitab, Quality Management, GMP, DOE, DMAIC, Supplier Quality, Product Development, Engineering, Process Development, Process Improvement, Cross-functional Team..., R&D, Root Cause Analysis, Statistics, Supplier Management, Kaizen, Manufacturing Management, Risk Management, Compliance, Auditing, cGMP, QSR, Change Management, Design of Experiments, Documentation, Problem Solving, Quality System, V&V, Process Engineering, Manufacturing..., ISO 14971, 5S
Education
Interamerican University 1998 — 2003
MBA, Industrial Management
Universidad de Puerto Rico 1988 — 1993
BSME, Mechanical Engineering
Bill Wiggins Bill Wiggins's Maetrics, LLC Experience August 2012 - April 2014
Job Sr. Manager, Field Assurance at MicroVention Terumo
Industry Medical Devices
Experience
MicroVention Terumo August 2015 - Present
HeartWare Inc November 2014 - August 2015
R & Q Solutions April 2014 - October 2014
Maetrics, LLC August 2012 - April 2014
Medical Device/Biotech February 2012 - September 2012
Medtronic April 2001 - January 2012
Vistakon, Inc March 1989 - April 2001
Skills
FDA, Quality Assurance, Quality Management, CAPA, Medical Devices, Validation, Sop, Cross-functional Team..., ISO 13485, V&V, Software Project..., Quality System, Auditing, Healthcare, GMP, Quality Complaint..., GMP Compliance Audits..., Quality Management..., 21 CFR Part 11, Team Management, Product Launch, SOPs, policies, plans,..., 21 CFR Parts 11, 803 &..., Quality Auditor, ISO, Continuous Improvement, Product Development, Complaint Management, Training, Design Control, Leadership, ISO 14971, Change Management, Quality Auditing, Regulatory Affairs, Coaching, Staff Development, Global Staff Management, Management, SOP
Education
University of Phoenix 2007 — 2010
BS, Nursing
Florida State College at Jacksonville
AS, Nursing
MicroVention Terumo August 2015 - Present
HeartWare Inc November 2014 - August 2015
R & Q Solutions April 2014 - October 2014
Maetrics, LLC August 2012 - April 2014
Medical Device/Biotech February 2012 - September 2012
Medtronic April 2001 - January 2012
Vistakon, Inc March 1989 - April 2001
Skills
FDA, Quality Assurance, Quality Management, CAPA, Medical Devices, Validation, Sop, Cross-functional Team..., ISO 13485, V&V, Software Project..., Quality System, Auditing, Healthcare, GMP, Quality Complaint..., GMP Compliance Audits..., Quality Management..., 21 CFR Part 11, Team Management, Product Launch, SOPs, policies, plans,..., 21 CFR Parts 11, 803 &..., Quality Auditor, ISO, Continuous Improvement, Product Development, Complaint Management, Training, Design Control, Leadership, ISO 14971, Change Management, Quality Auditing, Regulatory Affairs, Coaching, Staff Development, Global Staff Management, Management, SOP
Education
University of Phoenix 2007 — 2010
BS, Nursing
Florida State College at Jacksonville
AS, Nursing
Beth J. Cormier Beth J. Cormier's Maetrics, LLC Experience 2012 - 2012
Job Quality Manager
Industry Biotechnology
Experience
Jordi Labs May 2014 - September 2014
Adecco Engineering & Technical December 2013 - December 2013
Lang Pharma Nutrition, Inc. July 2013 - October 2013
Gemini Staffing Consultants LLC 2012 - 2012
Maetrics, LLC 2012 - 2012
TalentBurst, Inc 2012 - 2012
Smithers Viscient 2011 - 2012
Braintree Laboratories May 2008 - September 2011
Stryker Biotech October 2006 - December 2007
Genzyme September 2003 - October 2006
Skills
Quality Assurance, LIMS, GMP, Quality System, Biotechnology, Microsoft Word, Microsoft Excel, Microsoft Office, Change Control, Livelink, HPLC, FDA, Trackwise, PowerPoint, Adobe Professional, Document Management, NuGenesis, Internal Audit, External Audit, SharePoint, Microsoft Outlook, Plataeu LMS, OECD Section 8.2, SmartCapa, Microsoft PowerPoint, Internal Controls, Internal Audits, External Audits, Material Review Board, EPA 40CFR Parts 160 and..., FDA 21CFR Parts 11, 58,..., Document Control &..., Workingbird Training..., Familiar with ISO 9000..., Intermediate..., Intermediate verbal and..., Review and Release of..., Batch Review and..., Performed Ecological..., Written OJT's, SOPs,..., SOP, Hazardous Waste..., Hazardous Materials..., HazMat shipping,..., Pharmaceutical Industry, CAPA
Education
University of San Diego 1999 — 2003
Bachelor of Arts, Biology
Fairhaven High School 1995 — 1999
Honors/ Fairhaven High School
Jordi Labs May 2014 - September 2014
Adecco Engineering & Technical December 2013 - December 2013
Lang Pharma Nutrition, Inc. July 2013 - October 2013
Gemini Staffing Consultants LLC 2012 - 2012
Maetrics, LLC 2012 - 2012
TalentBurst, Inc 2012 - 2012
Smithers Viscient 2011 - 2012
Braintree Laboratories May 2008 - September 2011
Stryker Biotech October 2006 - December 2007
Genzyme September 2003 - October 2006
Skills
Quality Assurance, LIMS, GMP, Quality System, Biotechnology, Microsoft Word, Microsoft Excel, Microsoft Office, Change Control, Livelink, HPLC, FDA, Trackwise, PowerPoint, Adobe Professional, Document Management, NuGenesis, Internal Audit, External Audit, SharePoint, Microsoft Outlook, Plataeu LMS, OECD Section 8.2, SmartCapa, Microsoft PowerPoint, Internal Controls, Internal Audits, External Audits, Material Review Board, EPA 40CFR Parts 160 and..., FDA 21CFR Parts 11, 58,..., Document Control &..., Workingbird Training..., Familiar with ISO 9000..., Intermediate..., Intermediate verbal and..., Review and Release of..., Batch Review and..., Performed Ecological..., Written OJT's, SOPs,..., SOP, Hazardous Waste..., Hazardous Materials..., HazMat shipping,..., Pharmaceutical Industry, CAPA
Education
University of San Diego 1999 — 2003
Bachelor of Arts, Biology
Fairhaven High School 1995 — 1999
Honors/ Fairhaven High School
Lisa Joanne (Carter) Blanchard's Maetrics, LLC Experience March 2013 - April 2014
Job Compliance / Quality Specialist Consultant
Industry Medical Devices
Experience
HMA April 2014 - Present
Maetrics, LLC March 2013 - April 2014
Smiths Medical 2011 - 2012
Clarcor UK January 2010 - August 2011
Alpha Biolaboratories Ltd 2009 - 2010
Epistem Ltd. 2008 - 2009
IS Pharma Plc 2007 - 2008
3M Health Care Incorporating Biotrace Limited 2007 - 2008
MedImmuneUni 2002 - 2007
Skills
Quality System, Quality Assurance, Six Sigma, GMP, FDA, ISO 13485, ISO, Medical Devices, GLP, Auditing, Manufacturing, CAPA, Validation, V&V, Quality Auditing
Education
University of East London
BA (hons) Psychology with Counselling Studies
HMA April 2014 - Present
Maetrics, LLC March 2013 - April 2014
Smiths Medical 2011 - 2012
Clarcor UK January 2010 - August 2011
Alpha Biolaboratories Ltd 2009 - 2010
Epistem Ltd. 2008 - 2009
IS Pharma Plc 2007 - 2008
3M Health Care Incorporating Biotrace Limited 2007 - 2008
MedImmuneUni 2002 - 2007
Skills
Quality System, Quality Assurance, Six Sigma, GMP, FDA, ISO 13485, ISO, Medical Devices, GLP, Auditing, Manufacturing, CAPA, Validation, V&V, Quality Auditing
Education
University of East London
BA (hons) Psychology with Counselling Studies
Patrick Mahoney's Maetrics, LLC Experience June 2013 - July 2014
Job Recruiter at Theranos Inc.
Industry Biotechnology
Experience
Theranos Inc. September 2014 - Present
Maetrics, LLC June 2013 - July 2014
Kelly Scientific Resources March 2008 - May 2013
Skills
Applicant Tracking..., Biotechnology, Recruiting, Medical Devices, Technical Recruiting, Internet Recruiting, Talent Acquisition, Staffing Services, College Recruiting, Temporary Placement, Onboarding, Contract Recruitment, Sourcing, Training, Human Resources, Healthcare
Education
University of California, Santa Barbara 2002 — 2007
Bachelor of Science, Biological Sciences
Junipero Serra High School
Theranos Inc. September 2014 - Present
Maetrics, LLC June 2013 - July 2014
Kelly Scientific Resources March 2008 - May 2013
Skills
Applicant Tracking..., Biotechnology, Recruiting, Medical Devices, Technical Recruiting, Internet Recruiting, Talent Acquisition, Staffing Services, College Recruiting, Temporary Placement, Onboarding, Contract Recruitment, Sourcing, Training, Human Resources, Healthcare
Education
University of California, Santa Barbara 2002 — 2007
Bachelor of Science, Biological Sciences
Junipero Serra High School
Nick Nathan's Maetrics, LLC Experience November 2012 - Present
Job Manager at Maetrics, LLC
Industry Biotechnology
Experience
Maetrics, LLC November 2012 - Present
Baxter Healthcare July 2011 - November 2012
Skills
Process Improvement, FDA, Biotechnology, Lifesciences, Medical Devices, 21 CFR, Quality System, MDR, Pharmaceutical Industry, Compliance Remediation, Complaint Investigations, Quality Assurance, Cross-functional Team..., Team Leadership, Quality System..., Protocol, Data Analysis, Microsoft Excel, Microsoft Office, Microsoft Word, Project Management, GMP, Quality Control, CAPA, Regulatory Submissions, Post Market Surveillance, SAP, Pilgrim, Pharmacovigilance, Sop, Microbiology, Biochemistry, Research, V&V, SOP, Life Sciences
Education
Truman State University 2005 — 2010
Bachelor of Science, Biology
Maetrics, LLC November 2012 - Present
Baxter Healthcare July 2011 - November 2012
Skills
Process Improvement, FDA, Biotechnology, Lifesciences, Medical Devices, 21 CFR, Quality System, MDR, Pharmaceutical Industry, Compliance Remediation, Complaint Investigations, Quality Assurance, Cross-functional Team..., Team Leadership, Quality System..., Protocol, Data Analysis, Microsoft Excel, Microsoft Office, Microsoft Word, Project Management, GMP, Quality Control, CAPA, Regulatory Submissions, Post Market Surveillance, SAP, Pilgrim, Pharmacovigilance, Sop, Microbiology, Biochemistry, Research, V&V, SOP, Life Sciences
Education
Truman State University 2005 — 2010
Bachelor of Science, Biology
Alexandra Drury's Maetrics, LLC Experience March 2013 - May 2014
Job Quality Engineer at Synthes
Industry Medical Devices
Experience
DePuy Synthes Companies of Johnson & Johnson May 2014 - Present
Maetrics, LLC March 2013 - May 2014
Baxter Healthcare July 2011 - March 2013
University of Iowa May 2009 - September 2010
Archer Daniels Midland May 2008 - August 2008
Archer Daniels Midland May 2007 - August 2007
Skills
CAD, Microsoft Office, Finite Element Analysis, FDA, GMP, Technical Writing, Biomedical Engineering, HPLC, Matlab, Biotechnology, Biomechanics, Analysis, Medical Devices, Laboratory, Engineering, Product Development, Leadership, ISO 13485, Design Control, Validation, ISO 14971, Software Documentation, CAPA
Education
University of Iowa 2006 — 2010
Bachelor of Science in Engineering, Biomedical Engineering
DePuy Synthes Companies of Johnson & Johnson May 2014 - Present
Maetrics, LLC March 2013 - May 2014
Baxter Healthcare July 2011 - March 2013
University of Iowa May 2009 - September 2010
Archer Daniels Midland May 2008 - August 2008
Archer Daniels Midland May 2007 - August 2007
Skills
CAD, Microsoft Office, Finite Element Analysis, FDA, GMP, Technical Writing, Biomedical Engineering, HPLC, Matlab, Biotechnology, Biomechanics, Analysis, Medical Devices, Laboratory, Engineering, Product Development, Leadership, ISO 13485, Design Control, Validation, ISO 14971, Software Documentation, CAPA
Education
University of Iowa 2006 — 2010
Bachelor of Science in Engineering, Biomedical Engineering
Cindy T. Higgins's Maetrics, LLC Experience August 2006 - September 2006
Job Volunteer at Veterans Health Administration
Industry Biotechnology
Experience
Veterans Health Administration April 2011 - Present
High Desert Laboratories May 2008 - February 2009
Ventana Medical Systems 2009 - 2009
GE Healthcare August 2007 - May 2008
Maetrics LLC August 2006 - September 2006
Abbott Labs 2004 - 2006
FDA -PRLSW January 2002 - January 2003
Skills
Regulatory Affairs, Biotechnology, Compliance, Clinical, Diagnostics, Six Sigma, Regulatory Submissions, Documentation, FDA, Quality Systems, CAPA, GLP, ISO 13485, SOP, Validation, Life Sciences, Quality Assurance, 21 CFR Part 11, Process Validation, QSR, Auditing, cGMP, Medical Devices, ISO, Quality Management, GMP, Quality Auditing, GCP, Clinical Trials, Cross-functional Team...
Education
Villanova University 2011 — 2011
CLSSBB
University of the Pacific 1999 — 2001
Behavioral Health Science
University of Idaho 1975 — 1980
BS, Microbiology/Chemistry ( Medical Technology Sciences)
Hillcrest High School
Veterans Health Administration April 2011 - Present
High Desert Laboratories May 2008 - February 2009
Ventana Medical Systems 2009 - 2009
GE Healthcare August 2007 - May 2008
Maetrics LLC August 2006 - September 2006
Abbott Labs 2004 - 2006
FDA -PRLSW January 2002 - January 2003
Skills
Regulatory Affairs, Biotechnology, Compliance, Clinical, Diagnostics, Six Sigma, Regulatory Submissions, Documentation, FDA, Quality Systems, CAPA, GLP, ISO 13485, SOP, Validation, Life Sciences, Quality Assurance, 21 CFR Part 11, Process Validation, QSR, Auditing, cGMP, Medical Devices, ISO, Quality Management, GMP, Quality Auditing, GCP, Clinical Trials, Cross-functional Team...
Education
Villanova University 2011 — 2011
CLSSBB
University of the Pacific 1999 — 2001
Behavioral Health Science
University of Idaho 1975 — 1980
BS, Microbiology/Chemistry ( Medical Technology Sciences)
Hillcrest High School
Jeanne Leier's Maetrics, LLC Experience May 2013 - June 2015
Job Regulatory and Quality Clinical Specialist at NovusLife, LLC
Industry Medical Devices
Experience
NovusLife, LLC November 2014 - Present
Maetrics, LLC May 2013 - June 2015
Synovis Surgical Innovations September 2011 - September 2012
Medtronic Neuromodulation November 2008 - December 2010
American Medical Systems October 2007 - September 2008
Skills
Microsoft Excel, Access, PowerPoint, Microsoft Word, Medical Devices, Clinical Research, Clinical Trials, Cardiology, Hospitals, Healthcare, Lifesciences, Biotechnology, Clinical Data Management, Life Sciences, FDA, ISO 13485, Quality Assurance, Quality Control, Process Improvement
Education
University of Minnesota-Twin Cities 1985 — 1995
Bachlor of Arts, Germanic Philology & French Linguistic. Took all classes needed for entrance to Medical School s
NovusLife, LLC November 2014 - Present
Maetrics, LLC May 2013 - June 2015
Synovis Surgical Innovations September 2011 - September 2012
Medtronic Neuromodulation November 2008 - December 2010
American Medical Systems October 2007 - September 2008
Skills
Microsoft Excel, Access, PowerPoint, Microsoft Word, Medical Devices, Clinical Research, Clinical Trials, Cardiology, Hospitals, Healthcare, Lifesciences, Biotechnology, Clinical Data Management, Life Sciences, FDA, ISO 13485, Quality Assurance, Quality Control, Process Improvement
Education
University of Minnesota-Twin Cities 1985 — 1995
Bachlor of Arts, Germanic Philology & French Linguistic. Took all classes needed for entrance to Medical School s
Robert Lucas's Maetrics, LLC Experience May 2003 - September 2007
Job MGR; Quality Systems Business Partner at Zimmer
Industry Medical Devices
Experience
Zimmer Global Quality Systems ManagerZimmerApril 2009 - March 2013
Arbour Group LLC August 2007 - April 2009
Maetrics, LLC May 2003 - September 2007
Skills
Computer System..., Information Technology, QSR, Organizational..., International Project..., Cross-functional Team..., External Audit, Internal Audit, Team Building, Business Transformation, Manufacturing Operations, Business Development, Business Process..., Change Management, Training Delivery, Vendor Audit, Project Management, Software Quality..., Quality System, Organizational..., CAPA, Outsourcing, Design Control, Validation, Process Improvement, Leadership, Pharmaceutical Industry, ISO, Process Engineering, Quality Management, FDA, V&V, Quality Assurance, Medical Devices, Auditing, ISO 13485, 21 CFR Part 11, Change Control, Training, Quality Auditing, Management
Education
University of Massachusetts, Amherst 1989 — 1993
B.A., International Business/Psych
Zimmer Global Quality Systems ManagerZimmerApril 2009 - March 2013
Arbour Group LLC August 2007 - April 2009
Maetrics, LLC May 2003 - September 2007
Skills
Computer System..., Information Technology, QSR, Organizational..., International Project..., Cross-functional Team..., External Audit, Internal Audit, Team Building, Business Transformation, Manufacturing Operations, Business Development, Business Process..., Change Management, Training Delivery, Vendor Audit, Project Management, Software Quality..., Quality System, Organizational..., CAPA, Outsourcing, Design Control, Validation, Process Improvement, Leadership, Pharmaceutical Industry, ISO, Process Engineering, Quality Management, FDA, V&V, Quality Assurance, Medical Devices, Auditing, ISO 13485, 21 CFR Part 11, Change Control, Training, Quality Auditing, Management
Education
University of Massachusetts, Amherst 1989 — 1993
B.A., International Business/Psych
Kate Karberg's Maetrics, LLC Experience April 2013 - Present
Job Compliance & Quality Consultant at Maetrics, LLC
Industry Biotechnology
Experience
Maetrics, LLC April 2013 - Present
Baxter Healthcare November 2010 - April 2013
Delta Pharma 2010 - 2010
Skills
21 CFR Part 11, Change Control, Computer System..., FDA, GMP, ISO 13485, CAPA, Quality Assurance, Regulatory Affairs, Quality System, Sop, ISO 14971, Validation, Regulatory Submissions, V&V, Medical Devices, SOP
Education
University of Illinois at Urbana-Champaign 2006 — 2010
Bachelor of Science (B.S.), Molecular and Cellular Biology
Maetrics, LLC April 2013 - Present
Baxter Healthcare November 2010 - April 2013
Delta Pharma 2010 - 2010
Skills
21 CFR Part 11, Change Control, Computer System..., FDA, GMP, ISO 13485, CAPA, Quality Assurance, Regulatory Affairs, Quality System, Sop, ISO 14971, Validation, Regulatory Submissions, V&V, Medical Devices, SOP
Education
University of Illinois at Urbana-Champaign 2006 — 2010
Bachelor of Science (B.S.), Molecular and Cellular Biology
Janice Engels's Maetrics, LLC Experience July 2006 - April 2011
Job Compliance & Quality Consulting: Medical Device, Pharma, Biotech
Industry Management Consulting
Experience
Self-employed May 2011 - Present
Maetrics, LLC July 2006 - April 2011
Skills
Validation, ISO 13485, GMP, FDA, Business Process, Quality Management, Cross-functional Team..., Medical Devices, Sop, Biotechnology, V&V, CAPA, Quality Auditing, Change Control, Quality System, Regulatory Affairs, 21 CFR Part 11, Quality Assurance, Pharmaceutical Industry, Computer System..., SOP
Education
University of Cincinnati
BS, Chemistry
Self-employed May 2011 - Present
Maetrics, LLC July 2006 - April 2011
Skills
Validation, ISO 13485, GMP, FDA, Business Process, Quality Management, Cross-functional Team..., Medical Devices, Sop, Biotechnology, V&V, CAPA, Quality Auditing, Change Control, Quality System, Regulatory Affairs, 21 CFR Part 11, Quality Assurance, Pharmaceutical Industry, Computer System..., SOP
Education
University of Cincinnati
BS, Chemistry
Lou Oblitey's Maetrics, LLC Experience October 2013 - Present
Job Project Engineer IV at Jocobs Engineering
Industry Pharmaceuticals
Experience
Jocobs Engineering December 2014 - Present
Maetrics, LLC October 2013 - Present
Endo Pharmaceuticals July 2011 - 2013
Lannett Company November 2006 - July 2011
Gore November 2005 - November 2006
Skills
Validation, FDA, GMP, Technology Transfer, Sop, Regulatory Affairs, CAPA, Change Control, Cleaning Validation, 21 CFR Part 11, V&V, SOP, Quality Assurance, Quality System, Cross-functional Team..., Biotechnology, Pharmaceutical Industry
Education
University of Pittsburgh 1995 — 2000
BS, Chemical Engineering
Jocobs Engineering December 2014 - Present
Maetrics, LLC October 2013 - Present
Endo Pharmaceuticals July 2011 - 2013
Lannett Company November 2006 - July 2011
Gore November 2005 - November 2006
Skills
Validation, FDA, GMP, Technology Transfer, Sop, Regulatory Affairs, CAPA, Change Control, Cleaning Validation, 21 CFR Part 11, V&V, SOP, Quality Assurance, Quality System, Cross-functional Team..., Biotechnology, Pharmaceutical Industry
Education
University of Pittsburgh 1995 — 2000
BS, Chemical Engineering
Myrna Walters's Maetrics, LLC Experience September 2013 - December 2014
Job Post Market Surveillance Quality Analyst at 3M Health Care
Industry Medical Devices
Experience
Maetrics, LLC September 2013 - December 2014
Haemonetics August 2012 - August 2013
Pall Life Sciences March 2011 - July 2012
Pall Life Sciences February 2009 - September 2010
Armonia Bazaar August 2003 - June 2010
Pall Life Sciences April 2007 - January 2009
Advanced Technology Designs 2005 - 2007
Medtronic August 2002 - August 2003
Nellcor Tyco Healthcare January 2001 - May 2002
Nellcor Tyco Healthcare September 1997 - December 2000
Skills
Root Cause Problem..., Process Improvement, Lean Manufacturing, Quality System, CAPA, FDA GMP, SOP development, Compliance, Quality Trending, Policies & Metrics, Microsoft Office, ISO, Medical Devices, Supplier Performance, Calibration Process, Failure Analysis, Minitab, Six Sigma, Quality Control, MRB RGA, Customer Complaint..., Testing and Data..., Supervisory Experience, Continuous Improvement, Design of Experiments, DMAIC, Complaint Management, Manufacturing, Quality Assurance
Education
Universidad Autónoma de Baja California
Electronic Engineering
Maetrics, LLC September 2013 - December 2014
Haemonetics August 2012 - August 2013
Pall Life Sciences March 2011 - July 2012
Pall Life Sciences February 2009 - September 2010
Armonia Bazaar August 2003 - June 2010
Pall Life Sciences April 2007 - January 2009
Advanced Technology Designs 2005 - 2007
Medtronic August 2002 - August 2003
Nellcor Tyco Healthcare January 2001 - May 2002
Nellcor Tyco Healthcare September 1997 - December 2000
Skills
Root Cause Problem..., Process Improvement, Lean Manufacturing, Quality System, CAPA, FDA GMP, SOP development, Compliance, Quality Trending, Policies & Metrics, Microsoft Office, ISO, Medical Devices, Supplier Performance, Calibration Process, Failure Analysis, Minitab, Six Sigma, Quality Control, MRB RGA, Customer Complaint..., Testing and Data..., Supervisory Experience, Continuous Improvement, Design of Experiments, DMAIC, Complaint Management, Manufacturing, Quality Assurance
Education
Universidad Autónoma de Baja California
Electronic Engineering
Deloitte
PwC
Ernst & Young
Walgreens
Procter & Gamble
KPMG
PricewaterhouseCoopers
EY