Glumetrics, Inc.

Description

Address: 15375 Barranca Pkwy # I108, Irvine, CA 92618 Phone: (949) 579-1376: : : Category: : Place name: : : Website: Website: http://www.glumetrics.com/ Category: University Suggest an editUnable to add this file. Please check that it is a valid photo. Unable to add this file. Please check that it is a valid photo. · Own this business?

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Glumetrics, Inc. Employees

Employee
Years
Job
Industry
Matthew Romey Matthew Romey Orange County, California Area Details
Matthew Romey's Glumetrics, Inc. Experience November 2011 - September 2013
Job Project Manager at Azzur Consulting
Industry Medical Devices
Experience
Azzur Group  August 2014 - Present
Consulting Services  June 2014 - October 2014
GluMetrics, Inc.   November 2011 - September 2013
Glumetrics, Inc.   August 2007 - November 2011
Glumetrics, Inc.   May 2005 - August 2007
Terumo Cardiovascular Systems  1999 - 2005
3M Health Care  1992 - 1999

Skills
Medical Devices, R&D, Cross-functional Team..., Design Control, Validation, FDA, Biomedical Engineering, Product Development, ISO 13485, CAPA, Quality System, V&V, Project Management, Strategic Planning, Statistics, Chemistry, ISO 14971, Process Improvement, Biomaterials, Polymers, GLP, GMP, Lifesciences, Sop, Clinical Development, Clinical Research, Clinical Trials, Six Sigma, Software Documentation, 21 CFR Part 11, Manufacturing, Quality Control, HPLC, GCP, CTMS, Start-ups, Problem Solving, Process Simulation, Commercialization, Biotechnology, Sensors, Regulatory Affairs, Quality Assurance, Design of Experiments, Analytical Chemistry, FDA GMP, Product Launch, Quality Systems, Process Development, Life Sciences

Education
University of California, Irvine - The Paul Merage School of Business   2011 — 2013
Master of Business Administration (M.B.A.), Health Care Executive, 3.87 GPA

University of California, Berkeley
B.S., Chemistry

American Society for Quality
Certified Six Sigma Black Belt Refresher Course

University of California, Irvine - Extension
Project Management

William Markle William Markle San Diego, California Details
William Markle's Glumetrics, Inc. Experience January 2005 - March 2014
Job President and CEO at GlySens, Inc.
Industry Medical Devices
Experience
GlySens, Inc.   April 2015 - Present
GluMetrics, Inc.   January 2005 - March 2014
Tensys Medical  January 1999 - November 2004
Masimo  March 1995 - August 1998
Baxter Edwards Critical Care/LIS   December 1987 - November 1994
American Hospital Supply / Kendall McGaw   March 1986 - December 1987

Education
Pepperdine University   1985 — 1987
Master of Business Administration (MBA)

Duke University   1977 — 1981
Bachelor of Science (B.S.), Mechanical Engineering

Claudia Stefan Claudia Stefan Suffolk, Virginia Details
Claudia Stefan's Glumetrics, Inc. Experience July 2006 - July 2010
Job Quality Control Technician
Industry Printing
Experience
Vitex Packaging Group  March 2013 - Present
Glumetrics, Inc.   July 2006 - July 2010
SenoRx  August 1999 - July 2002
Micro therapeutics, Inc. (ev3, Inc.)   February 1997 - August 1999

Skills
New Product Assembly..., New Product Validation, Quality Inspection, Train New Employees, Product Development, Product Design, Manufacturing

Education
Chattanooga State Community College

MiraCosta College

Sonia Loya Sonia Loya San Juan Capistrano, California Details
Sonia Loya's Glumetrics, Inc. Experience June 2008 - January 2014
Job Document Control Clerk at Sonendo®, Inc.
Industry Medical Devices
Experience
Sonendo®, Inc.   March 2014 - Present
GluMetrics, Inc.   June 2008 - January 2014

Skills
Document Management, Document Review, File Management, File Systems, File Archiving, Clerical Skills, Communication Skills, High Organizational..., Computer Proficiency, Internal Audit, Quality Auditing, FDA, ISO 13485, Cross-functional Team..., GMP, Design Control, Medical Devices, Quality Control, Quality System

Education
Saddleback College   2012 — 2014

Kenneth Chesnin Kenneth Chesnin Long Beach, California Details
Kenneth Chesnin's Glumetrics, Inc. Experience August 2010 - January 2014
Job Director of Research and Development at ClearFlow, Inc.
Industry Medical Devices
Experience
ClearFlow, Inc.   March 2014 - Present
Glumetrics, Inc.   August 2010 - January 2014
Medcomp & Martech Medical   1999 - July 2010
Thomas Jefferson University  1994 - 1999

Skills
Medical Devices, ISO 13485, Design Control, Quality System, R&D, Injection Molding, Product Development, Biomaterials, Sensors, Solidworks, Polymers, Extrusion, Validation, V&V, Product Launch, vascular devices, Engineering, Commercialization, Design of Experiments, ISO 14971, Biomedical Engineering, FDA, Design for Manufacturing, Biotechnology, Plastics, Product Design, SPC, Manufacturing, CAPA, FMEA, Minitab, Manufacturing..., GMP, Root Cause Analysis, ISO, Catheters, Six Sigma, Cross-functional Team..., Quality Control, Failure Analysis, Project Management

Education
Drexel University   1993 — 1996
MS

University at Buffalo   1989 — 1993
BS

Darren LaCour Jr. Darren LaCour Jr. Orange County, California Area Details
Darren LaCour Jr.'s Glumetrics, Inc. Experience September 2011 - September 2012
Job Certified Clinical Research Professional
Industry Medical Devices
Experience
Medtronic  October 2014 - Present
Endologix Inc  March 2014 - October 2014
Endologix Inc  September 2012 - January 2014
Glumetrics, Inc.   September 2011 - September 2012
GluMetrics, Inc.   May 2010 - September 2011
B. Braun Medical  August 2007 - May 2010

Skills
ISO, GLP, GCP, Clinical Development, Clinical Research, Clinical Study Design, Design Control, Clinical Trials, Medical Devices, Product Development

Education
Northeastern University   2010 — 2011
M.S., Regulatory Affairs for Pharmaceuticals, Medical Devices, Biologics

University of California, Irvine   2010 — 2010
Certificate, Clinical Trials: Medical Device and Drug Development

Xavier University of Louisiana   2003 — 2007
Bachelors of Science, Biology

Soya Gamsey Soya Gamsey San Francisco, California Details
Soya Gamsey's Glumetrics, Inc. Experience 2009 - 2011
Job VP Chemistry Development at PROFUSA
Industry Medical Devices
Experience
PROFUSA  2011 - Present
Glumetrics, Inc.   2009 - 2011
Glumetrics, Inc.   2007 - 2009
Glumetrics, Inc.   2006 - 2007
Geron  1998 - 2001

Skills
Organic Synthesis, Fluorescence, Product Development, Nucleic Acid, Project Management, Organic Chemistry, Chemistry, NMR, HPLC, R&D, Fiber Optics, Polymers, Medical Devices, Biomedical Engineering, Biotechnology

Education
University of California, Santa Cruz   2001 — 2006
Ph.D., Organic Chemistry

Reed College   1993 — 1997
B.A., Chemistry

Charles Maung Charles Maung Irvine, California Details
Charles Maung's Glumetrics, Inc. Experience June 2012 - Present
Job Manufacturing Chemist at Glumetrics, Inc.
Industry Medical Devices
Experience
Glumetrics, Inc.   June 2012 - Present
City of Daly City  June 2006 - August 2008

Skills
Chemistry, Biomedical Engineering, NMR, Organic Chemistry, Computer Repair, Online Search, Laboratory Skills, IR spectroscopy, HPLC, Mass Spectrometry, Glove Box, Microsoft Office, Linux, Ubuntu, Networking, Spreadsheets, Column Chromatography, ChemDraw, Analytical Chemistry, Chromatography, Organic Synthesis, V&V, Wet Chemistry, UV/Vis, IR, GLP, Gas Chromatography, Computers, NMR spectroscopy, Air-sensitive chemistry, Mac OS X, Biotage, Polymerization, Feedback Control Systems, Cleanroom Procedures, Report generation, Inventory Management, Product Cost Analysis, Windows, Laboratory Equipment, Water Treatment, Quality Control, Rapid Prototyping, Spectrophotometry, Polymers, FDA, OS X, CAPA

Education
UC Irvine   2008 — 2012
Bachelor of Science (BS), Chemistry

Mark Buhr Mark Buhr Orange County, California Area Details
Mark Buhr's Glumetrics, Inc. Experience 2007 - 2007
Job Medical Devices, R&D, Product/Process Design, Manufacturing/R&D Tooling & Process Specialist
Industry Medical Devices
Experience
Contract  2012 - Present
TherOx  September 1995 - October 2011
Glumetrics, Inc.   2007 - 2007
SenoRx (now Bard Biopsy Systems)   September 2003 - December 2006
Spectrum Labs  August 2002 - September 2003
Devices for Vascular Intervention (Guidant- BS-Abbott)   October 1992 - August 1995
InterTherapy Inc   June 1987 - September 1992

Skills
R&D, Product Development, Automation, Medical Devices, Design of Experiments, Design for Manufacturing, R&D/Production assembly..., Machinist

Education
Texas State Technical College Harlingen   1983 — 1986
Associate of Science, Computer Science

Bruce Feuchter Bruce Feuchter Newport Beach, California Details
Bruce Feuchter's Glumetrics, Inc. Experience February 2006 - May 2014
Job Outside General counsel at Gobiquity, Inc.
Industry Law Practice
Experience
Gobiquity, Inc.   2014 - Present
Ivantis, Inc.   February 2008 - Present
Tandem Diabetes Care, Inc.   January 2005 - Present
ReShape Medical   2005 - Present
ReVision Optics, Inc.   June 2004 - Present
Stradling Yocca Carlson & Rauth  March 1981 - Present
Stradling Yocca Carlson & Rauth  March 1981 - Present
Glumetrics, Inc.   February 2006 - May 2014
Altura Medical, Inc.   January 2009 - April 2014
WaveTec Vision  2005 - 2014

Skills
Mergers, Venture Capital, Intellectual Property, Medical Devices, Start-ups, Trade Secrets, Mergers & Acquisitions, Corporate Law, Lifesciences, Venture Financing, Arbitration, Management, Strategy, Leadership, Commercial Litigation, Licensing, Patents, Contract Negotiation, Litigation, IPO, Securities Regulation, Joint Ventures, Life Sciences

Education
University of California, Berkeley, Haas School of Business   1977 — 1979
MBA, Finance

University of California, Hastings College of the Law   1975 — 1979
JD, Law

University of California, Berkeley   1973 — 1975
BA, Economics

Noah Young Noah Young United States Details
Noah Young's Glumetrics, Inc. Experience June 2012 - November 2012
Job Graduate Student Researcher in The Deisseroth Lab
Industry Research
Experience
The Deisseroth Lab   June 2013 - Present
Glumetrics, Inc.   June 2012 - November 2012
Johns Hopkins University  April 2011 - June 2012
Hopkins Consulting Agency   September 2009 - May 2012
Dr. Jordan Green's Lab   January 2011 - December 2011
JHU High Throughput Biology Lab   June 2010 - September 2010
Dr. Joel Bader's Lab   June 2010 - September 2010
Abbott Medical Optics  May 2009 - August 2009

Skills
Machine Learning, Statistics, Linear algebra, Computational..., Data Analysis, Big Data Analytics, Mathematical Modeling, Amazon Web Services..., Unix, Computational optics, Python, Matlab, Biomedical Engineering, Synthetic Biology, Medical Devices, Laboratory Automation, Convex Optimization, Apache Spark, Git, Technology Transfer, Optics, Fluorescence Microscopy

Education
Stanford University   2012 — 2018
Doctor of Philosophy (Ph.D.), Bioengineering

Stanford University   2012 — 2014
Master of Science (M.S.), Bioengineering

The Johns Hopkins University   2008 — 2012
Bachelor of Science (B.S.), Biomedical Engineering; Applied Mathematics & Statistics

Thomas Berryman Thomas Berryman Orange County, California Area Details
Thomas Berryman's Glumetrics, Inc. Experience 2005 - 2014
Job Founder Soft Health Technologies LLC
Industry Medical Devices
Experience
Soft Health Technologies LLC   2012 - Present
Invoy Technologies, LLC   2012 - Present
OCTANe  2005 - Present
Glumetrics, Inc.   2005 - 2014
Growers First   2010 - 2012
WaveTec Vision  2005 - 2010
Genyx Medical, Inc.   1997 - 2005
MicroTherapeutics, Inc.   1993 - 1997
Advanced Surgical Intervention   1988 - 1993
VLI Corporation   1985 - 1988

Skills
Start-ups, Strategy, Entrepreneurship, Medical Devices, Venture Capital, Leadership, Strategic Planning, Business Development, Commercialization, Management, Financial Modeling, Debt & Equity Financing, Intellectual Property

Education
University of California, Irvine - The Paul Merage School of Business   1986 — 1988
MBA

California State Polytechnic University-Pomona   1973 — 1978
BS, Accounting

Tricia Zubke Tricia Zubke Orange County, California Area Details
Tricia Zubke's Glumetrics, Inc. Experience April 2013 - March 2014
Job
Industry Professional Training & Coaching
Experience
Zubke Consulting   April 2014 - Present
GluMetrics, Inc.   April 2013 - March 2014
GluMetrics, Inc.   October 2005 - April 2013
Cambridge Financial Management Inc.   January 1996 - September 2005
Richard Gast & Associates   January 1995 - January 1996

Skills
Office Management, Microsoft Office, Time Management, Project Coordination, Supervisory Skills, Quickbooks, Project Planning, Purchasing, IT Management, Multitasker, Facilities Management, Organizing, Budgeting, Cash Flow Management, Needs Analysis, Accounting, Administration, Documentation, Controller, Shutdown, Start-up Consulting

Education
Concordia University-Irvine   1991 — 1995
BA, Business Management

Monica Swinney, Ph.D. Monica Swinney, Ph.D. Greater Boston Area Details
Monica Swinney, Ph.D.'s Glumetrics, Inc. Experience February 2010 - April 2010
Job Senior Staff Engineer, Advanced Diabetes Care at BD
Industry Medical Devices
Experience
BD  February 2015 - Present
BD  April 2010 - January 2015
Glumetrics, Inc.   February 2010 - April 2010
DexCom  2007 - 2010
DexCom  January 2005 - April 2007
Johnson & Johnson  January 2004 - December 2004

Skills
Clinical Trials, Research, Medical Devices, ISO 13485, Design Control, FDA, Validation, Biomedical Engineering, R&D, GMP, Biotechnology, Commercialization, Lifesciences, V&V, Solidworks, Statistical Data..., GLP, ISO 10993

Education
Massachusetts Institute of Technology   1999 — 2003
Ph.D., Polymer Science & Technology

University of Massachusetts at Lowell   1997 — 1999
B.S, Chemistry, Magna Cum Laude

The University of Texas at Dallas   1995 — 1997
Chemistry

Christian Schulz Christian Schulz Sacramento, California Area Details
Christian Schulz's Glumetrics, Inc. Experience January 2011 - March 2013
Job Mechanical Engineering Consultant, Edwards LifeSciences
Industry Medical Devices
Experience
Edwards Lifesciences  January 2014 - Present
Volcano Corporation  April 2013 - December 2013
Glumetrics, Inc.   January 2011 - March 2013
Glumetrics, Inc.   March 2009 - January 2011
Verifone  September 2004 - March 2009
Masimo Corporation  1998 - 2004
Rembrandt   1996 - 1998

Skills
Sensors, V&V, AutoCAD, Manufacturing, Product Development, Payments, ISO 13485, Validation, R&D, Design Control, Biomedical Engineering, Program Management, Engineering, Quality System, Labview, Medical Devices, Cross-functional Team..., Injection Molding, ISO 14971, Embedded Systems, GMP, FDA, Design for Manufacturing, Product Design, Solidworks, Engineering Management, Wireless, Start-ups, Electronics, FMEA, Molding, Manufacturing..., Polymers, Product Launch, Design of Experiments, Biomaterials, Tolerance Analysis, SPC, CAPA, NI LabVIEW, Capital Equipment, DMAIC

Education
California State University-Long Beach   1994 — 2001
MSME, Mechanical Engineering

California State University-Long Beach   1987 — 1992
BSME, Mechanical Engineering

TCHS

Helene Spencer Helene Spencer Orange County, California Area Details
Helene Spencer's Glumetrics, Inc. Experience 2005 - 2009
Job RA/QA Consultant
Industry Medical Devices
Experience
ClinReg Consulting Services   May 2009 - Present
Ivantis, Inc  2010 - 2011
Orange County Requlatory Affairs (OCRA)   2005 - 2011
Glumetrics, Inc.   2005 - 2009
Microvention  1998 - 2000

Skills
FDA, Medical Devices, ISO, Regulatory Submissions, Technology Transfer, Biotechnology, Biomedical Engineering, Regulatory Affairs, Quality System, R&D, Quality Assurance, V&V, GMP, Validation, ISO 13485, Quality Management, CAPA, Quality Control, Product Development, Design Control, Change Control, Clinical Trials, Quality Auditing, Pharmaceutical Industry, ISO 14971, Lifesciences, 21 CFR Part 11, Manufacturing, Commercialization, Cross-functional Team..., Design of Experiments, Regulatory Requirements

Education
University of California, Santa Barbara   1965 — 1969
BA, Chemistry

University of California, Los Angeles

Mary Librande Mary Librande Orange County, California Area Details
Mary Librande's Glumetrics, Inc. Experience June 2012 - September 2013
Job Clinical Complaint Specialist at Endologix Inc
Industry Hospital & Health Care
Experience
Endologix Inc  April 2014 - Present
Prolistic Health Systems   January 2008 - Present
Glumetrics, Inc.   June 2012 - September 2013
GluMetrics   2008 - 2012
Hoag Hospital  2001 - November 2011
Hoag Hospital  January 2010 - May 2010
Hoag Hospital  1996 - 2001
Hoag Hospital  1993 - 1998
Lakewood Regional Medical Center  October 1982 - June 1993

Skills
Nursing, Hospitals, Healthcare, EMR, EHR, Healthcare IT, Clinical Informatics, Acute Care, Nurses, Healthcare Management, Inpatient, Healthcare Information..., Clinical Research, Clinical Trials, Informatics, Medical Devices, CPOE, Epic Systems, Software Documentation, Radiology, Medicine, Healthcare Consulting, Critical Care, HIPAA, Quality Improvement, Meditech, Interventional Radiology, Process Improvement, Physicians, ACLS, ICU, Data Analysis, JCAHO, Medical Device R&D, BLS, Documentations, Healthcare Industry, Training, Ambulatory, Leadership, Revenue Cycle, Clinical Development, Physician Relations, Health Information..., Disease Management, Documentation

Education
Walden University   2007 — 2010
Graduate, MSN - Nursing Informatics

Vanguard University of Southern California   1998 — 2003
Undergraduate, Business

Orange Coast College   1999 — 2001
Business Management

Elgin Community College   1979 — 1982
Associate, Applied Science in Nursing

Nadia Noharuddin Nadia Noharuddin Greater San Diego Area Details
Nadia Noharuddin's Glumetrics, Inc. Experience April 2013 - Present
Job R&D Engineer Sensor at Glumetrics, Inc.
Industry Medical Devices
Experience
Glumetrics, Inc.   April 2013 - Present
Alcon Laboratories, Inc.   December 2009 - March 2013
Hewlett-Packard  March 2007 - June 2010
Carnegie Mellon University  May 2005 - December 2006
Proton  May 2004 - August 2004

Skills
Product Lifecycle..., Management, Test Design, Six Sigma, Design of Experiments, Matlab, Engineering, Product Development, Mechanical Engineering, Solidworks, Manufacturing, Testing, R&D, C++, Project Management, Program Management, Quality Assurance, FDA, Design for Manufacturing, Characterization, Engineering Management, Labview

Education
Carnegie Mellon University   2005 — 2006
M.S., Mechanical Engineering

Carnegie Mellon University   2002 — 2006
B.S., Mechanical Engineering

United Nations International School

Behraam Baqai Behraam Baqai Irvine, California Details
Behraam Baqai's Glumetrics, Inc. Experience June 2011 - August 2011
Job R&D Engineer | Medical Device Design | CAD | Master of Engineering in Biomedical Engineering
Industry Medical Devices
Experience
Medtronic Neurovascular (Formerly Covidien NV/ev3)   October 2014 - Present
Tenacore Holdings, Inc.   May 2013 - August 2013
USC Underwater Autonomous Vehicle Team   September 2010 - July 2013
University of Southern California Libraries   March 2011 - May 2013
Glumetrics, Inc.   June 2011 - August 2011
University of Southern California Library Security   January 2010 - March 2011

Skills
SolidWorks, Matlab, Biomedical Engineering, Engineering, Microsoft Office, Data Analysis, Microsoft Excel, CAD, Medical Devices, PowerPoint, Leadership, Analysis, Statistics, Microsoft Word, Solid Edge, Testing, Windows, Fixture Design, Excel, Word, MS Office Suite, NI LabVIEW, Simulink, LabVIEW, Packaging, Medical Device R&D, Nitinol

Education
Boston University   2013 — 2014
Master of Engineering (MEng), Biomedical Engineering

University of Southern California   2009 — 2013
B.S., Biomedical Engineering (Mechanical)

Northwood High School   2005 — 2009

Chi A. Chau Chi A. Chau Orange County, California Area Details
Chi A. Chau's Glumetrics, Inc. Experience May 2012 - Present
Job Clinical research
Industry Medical Devices
Experience
InnFocus, Inc   2013 - Present
Glumetrics, Inc.   May 2012 - Present
Glaukos Corporation  July 2008 - March 2012

Skills
Clinical Trials, ISO 13485, Biomedical Engineering, FDA, Medical Devices, GCP, CRO, Design Control, CTMS, Clinical Research, Clinical Development, ICH-GCP, Ophthalmology, GLP, 21 CFR Part 11, Protocol, Clinical Study Design, Clinical Monitoring, PMA, Clinical Operations, EDC, Regulatory Submissions, Biotechnology, CAPA

Education
The George Washington University School of Medicine and Health Sciences   2004 — 2006
MSHS, Health Professions and Related Clinical Sciences, Other

University of Utah
BS, Behavior Science and Health

Steven Wikse Steven Wikse Orange County, California Area Details
Steven Wikse's Glumetrics, Inc. Experience 2006 - 2012
Job Project Manager at RF Surgical Systems, Inc
Industry Medical Devices
Experience
RF Surgical Systems, Inc  May 2014 - Present
GluMetrics   2012 - January 2014
GluMetrics, Inc.   2006 - 2012
IntraLuminal Therapeutics, Inc.   2000 - 2006
TherOx  June 1999 - December 1999
TherOx  July 1998 - June 1999
Biopsys Medical   1994 - 1998

Skills
Manufacturing, Medical Devices, ISO 13485, FDA, Quality System, R&D, Biomedical Engineering, CAPA, Cross-functional Team..., Product Development, GMP, Clinical Trials, V&V, Quality Assurance, Strategic Planning, ISO 14971, Sensors, Manufacturing..., Product Launch, Process Simulation, Commercialization, Engineering Management, Validation, FMEA, Embedded Systems, Engineering, Labview, Quality Control, Project Management, Qualitative Research, Solidworks, Design Control, Injection Molding, Market Development, Plastics, Clinical Research, Start-ups

Education
California Polytechnic State University-San Luis Obispo   1989 — 1993
Bachelor of Science (BS), Aeronautical Engineering

UC Irvine, Extension

Jessica Dang Jessica Dang Orange County, California Area Details
Jessica Dang's Glumetrics, Inc. Experience February 2008 - January 2014
Job R&D Technician/MFG Line Lead at Glumetrics, Inc.
Industry Medical Devices
Experience
GluMetrics, Inc.   February 2008 - January 2014
Micro Vention Terumo, Inc   March 2001 - February 2008

Skills
Medical Devices, Cross-functional Team..., Manufacturing, Validation, Lifesciences, Polymers, Solidworks, Quality System, Microsoft Office, Biotechnology, Chemistry, Engineering, Fiber Optics, Clinical Trials, Labview, Sensors, R&D, Quality Control, Analytical Chemistry, GMP, GLP, HPLC, ISO 13485, Quality Assurance, Design Control, Product Development, FDA, Biomedical Engineering, Laboratory Technicians, Team Leadership

Education
Boston Reed College   2008 — 2009
Pharmacy Technician/Assistant

Saddleback College   1999 — 2001
Computer and Information Management

Economic University of Ho Chi Minh City, Vietnam   1994 — 1997
Bachelor's Degree, Accounting and Finance

Paul Gasser Paul Gasser Santa Ana, California Details
Paul Gasser's Glumetrics, Inc. Experience August 2009 - September 2013
Job Medical Device RA/QA Consultant
Industry Medical Devices
Experience
Self-employed  September 2013 - Present
GluMetrics, Inc.   August 2009 - September 2013
Devax, Inc.   February 2006 - July 2009
Savacor, Inc.   January 2002 - January 2006
Radiance Medical Systems   April 1999 - December 2001
Steri-Oss   September 1992 - April 1999
Allergan Medical Optics  April 1990 - September 1992
Kendall McGaw Laboratories   May 1983 - April 1990

Skills
FDA, Regulatory Affairs, NBs/competent..., 510(k), PMA, IDE, CE marking, Quality Assurance, Quality Systems, Inspections/assessments, Document control, Auditing, Test protocols/reports, Labeling, Validation, Product complaints, MDR, vigilance, Recalls/withdrawals, GLPs, Hardware/software, Clinicals, GCPs, Quality Control, Clinical Trials, Document Management, Quality System, Cross-functional Team..., Product Complaints, Design Control, Medical Devices, Biotechnology, GMP, ISO 13485, R&D, V&V, CAPA

Education
Chapman University, The George L. Argyros School of Business and Economics   1988 — 1990
Master of Business Administration (MBA)

University of California, Irvine   1978 — 1982
Bachelor of Science (BS), Biology, General