DEKRA Certification B.V.
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DEKRA Certification B.V. Employees
Employee
Years
Job
Industry
Harshit Thakkar Harshit Thakkar's DEKRA Certification B.V. Experience February 2009 - Present
Job Project Manager CE certification for Medical Devices
Industry Medical Devices
Experience
DEKRA Certification B.V. February 2009 - Present
University of Southern California August 2007 - December 2008
Beckman Coulter May 2008 - August 2008
Lilavati Hospital and Research Center July 2006 - December 2007
Skills
ISO 13485, CE marking, Medical Devices, ISO 14971, Regulatory Affairs, Regulatory Strategy, FDA, Clinical Trials, Strategy, Quality System, Biotechnology, Biomedical Engineering, Medical Imaging, CAPA, Design Control, V, Validation, V&V, Quality Assurance
Education
University of Southern California 2007 — 2008
Master, Medical Device and Diagnostic Engineering - Regulatory Track
Dwarakadas J Sanghvi College of Engineering 2003 — 2007
Bachelor, Biomedical Engineering
University of Mumbai 2003 — 2007
Bachelor's, Biomedical
DEKRA Certification B.V. February 2009 - Present
University of Southern California August 2007 - December 2008
Beckman Coulter May 2008 - August 2008
Lilavati Hospital and Research Center July 2006 - December 2007
Skills
ISO 13485, CE marking, Medical Devices, ISO 14971, Regulatory Affairs, Regulatory Strategy, FDA, Clinical Trials, Strategy, Quality System, Biotechnology, Biomedical Engineering, Medical Imaging, CAPA, Design Control, V, Validation, V&V, Quality Assurance
Education
University of Southern California 2007 — 2008
Master, Medical Device and Diagnostic Engineering - Regulatory Track
Dwarakadas J Sanghvi College of Engineering 2003 — 2007
Bachelor, Biomedical Engineering
University of Mumbai 2003 — 2007
Bachelor's, Biomedical
Jennifer Drummond Jennifer Drummond's DEKRA Certification B.V. Experience September 2004 - Present
Job Senior Executive Assistant & Food Blogger
Industry Medical Devices
Experience
DEKRA Certification B.V. September 2004 - Present
Peanut Butter and Peppers September 2011 - Present
B&L Medical October 2002 - June 2004
Skills
Cooking, Food, Social Networking, Baking, Social Media, Recipes, Customer Service, Event Management, Management, Microsoft Office, Microsoft Excel, Marketing, Entrepreneurship, Leadership, Research, Strategic Planning, Blogging, Event Planning
Education
Erie Community College 1990 — 1992
Business Administration and Management, General
DEKRA Certification B.V. September 2004 - Present
Peanut Butter and Peppers September 2011 - Present
B&L Medical October 2002 - June 2004
Skills
Cooking, Food, Social Networking, Baking, Social Media, Recipes, Customer Service, Event Management, Management, Microsoft Office, Microsoft Excel, Marketing, Entrepreneurship, Leadership, Research, Strategic Planning, Blogging, Event Planning
Education
Erie Community College 1990 — 1992
Business Administration and Management, General
Mark Chen, MSc QA Mark Chen, MSc QA's DEKRA Certification B.V. Experience July 2013 - Present
Job Consultant, QMS Auditor at DEKRA Certification
Industry Medical Devices
Experience
Vention Medical August 2013 - Present
DEKRA Certification B.V. July 2013 - Present
MedQ Systems June 2012 - Present
Medical Device RA/QA Consulting March 2004 - Present
EndoSee January 2013 - October 2014
Asthmatx April 2004 - April 2005
Boston Scientific January 2000 - February 2004
Medtronic Vascular July 1995 - November 1999
Medtronic February 1992 - July 1995
Laserscope February 1990 - February 1992
Skills
Medical Devices, Quality Assurance, Compliance, Speak/read/write Chinese, Foreign Languages, FDA GMP, ISO 9000, ISO 13485, MDD, Quality Engineering, Quality System Auditing, Quality System..., Master Degree in Quality, Quality Control, Validation, Medical Device Directive, FDA, V&V, Quality System, Quality Auditing, Design Control, Iso 9000, CAPA, Supplier Quality, GMP, ISO 14971, Catheters, Testing, Start-ups, PMA, ISO, Biomedical Engineering, Quality Management, 21 CFR Part 11, Sterilization, CE marking, 21 CFR, Manufacturing, Technical Files, Regulatory Affairs, Change Control, Design of Experiments, Biocompatibility
Education
Western Seminary
Master of Arts (MA), Ministry of Evangelism and Equipping
San Jose State University 1991 — 1995
Master of Science (M.Sc.), Quality Assurance
San Jose State University 1986 — 1988
Bachelor of Science (BS), Industrial Technology, Emphasis in Computer Electronics, Minored in Business Management, with distinction
De Anza College 1978 — 1986
AA, Automotive Technology, Electronic Technologies
Henry M. Gunn High School
High school diploma, General ed., Auto shop, Tech drawing
Vention Medical August 2013 - Present
DEKRA Certification B.V. July 2013 - Present
MedQ Systems June 2012 - Present
Medical Device RA/QA Consulting March 2004 - Present
EndoSee January 2013 - October 2014
Asthmatx April 2004 - April 2005
Boston Scientific January 2000 - February 2004
Medtronic Vascular July 1995 - November 1999
Medtronic February 1992 - July 1995
Laserscope February 1990 - February 1992
Skills
Medical Devices, Quality Assurance, Compliance, Speak/read/write Chinese, Foreign Languages, FDA GMP, ISO 9000, ISO 13485, MDD, Quality Engineering, Quality System Auditing, Quality System..., Master Degree in Quality, Quality Control, Validation, Medical Device Directive, FDA, V&V, Quality System, Quality Auditing, Design Control, Iso 9000, CAPA, Supplier Quality, GMP, ISO 14971, Catheters, Testing, Start-ups, PMA, ISO, Biomedical Engineering, Quality Management, 21 CFR Part 11, Sterilization, CE marking, 21 CFR, Manufacturing, Technical Files, Regulatory Affairs, Change Control, Design of Experiments, Biocompatibility
Education
Western Seminary
Master of Arts (MA), Ministry of Evangelism and Equipping
San Jose State University 1991 — 1995
Master of Science (M.Sc.), Quality Assurance
San Jose State University 1986 — 1988
Bachelor of Science (BS), Industrial Technology, Emphasis in Computer Electronics, Minored in Business Management, with distinction
De Anza College 1978 — 1986
AA, Automotive Technology, Electronic Technologies
Henry M. Gunn High School
High school diploma, General ed., Auto shop, Tech drawing
Chris Sarner Chris Sarner's DEKRA Certification B.V. Experience 2012 - Present
Job Sr. Project Manager of Medical Device Certification at DEKRA
Industry Medical Devices
Experience
DEKRA Certification B.V. 2012 - Present
UC Irvine 2012 - 2014
SinoMed Group (BVI) Limited 2011 - 2012
Sarner Biomedical Consulting 2007 - 2012
Direct Flow Medical 2010 - 2011
Arbor Surgical Technologies 2009 - 2010
Solace Therapeutics 2007 - 2009
Edwards Lifesciences 2005 - 2007
Edwards Lifesciences 2001 - 2005
Baxter Healthcare 1996 - 2001
Skills
Product Development, Team Building, Marketing Strategy, Medical Devices, Management, Program Management, Regulatory Affairs, Marketing, Global Regulatory..., Quality Assurance, Sterilization, Tissue Processing, Biocompatibility, Quality System, Design Control, FDA, GMP, Validation, CAPA, ISO 13485, Project Management, Biotechnology, Strategy, Leadership, Design of Experiments, R&D, ISO 14971, Biomedical Engineering, Manufacturing, Six Sigma, V&V, ISO, Quality Management, Cross-functional Team..., Commercialization, Regulatory Submissions, Start-ups, Product Management, Lifesciences, Product Launch, Market Research, Business Development, Pharmaceutical Industry, Clinical Trials, Technology Transfer, Entrepreneurship, Clinical Research, Clinical Development, Mergers & Acquisitions, Life Sciences
Education
Pepperdine University, The George L. Graziadio School of Business and Management 2005 — 2009
MBA
University of California, Irvine 1981 — 1985
BS
DEKRA Certification B.V. 2012 - Present
UC Irvine 2012 - 2014
SinoMed Group (BVI) Limited 2011 - 2012
Sarner Biomedical Consulting 2007 - 2012
Direct Flow Medical 2010 - 2011
Arbor Surgical Technologies 2009 - 2010
Solace Therapeutics 2007 - 2009
Edwards Lifesciences 2005 - 2007
Edwards Lifesciences 2001 - 2005
Baxter Healthcare 1996 - 2001
Skills
Product Development, Team Building, Marketing Strategy, Medical Devices, Management, Program Management, Regulatory Affairs, Marketing, Global Regulatory..., Quality Assurance, Sterilization, Tissue Processing, Biocompatibility, Quality System, Design Control, FDA, GMP, Validation, CAPA, ISO 13485, Project Management, Biotechnology, Strategy, Leadership, Design of Experiments, R&D, ISO 14971, Biomedical Engineering, Manufacturing, Six Sigma, V&V, ISO, Quality Management, Cross-functional Team..., Commercialization, Regulatory Submissions, Start-ups, Product Management, Lifesciences, Product Launch, Market Research, Business Development, Pharmaceutical Industry, Clinical Trials, Technology Transfer, Entrepreneurship, Clinical Research, Clinical Development, Mergers & Acquisitions, Life Sciences
Education
Pepperdine University, The George L. Graziadio School of Business and Management 2005 — 2009
MBA
University of California, Irvine 1981 — 1985
BS
Daniela Shelley Daniela Shelley's DEKRA Certification B.V. Experience June 2008 - April 2010
Job Product Support Engineer at VerintSystems
Industry Computer Software
Experience
Verint-Systems July 2011 - April 2015
Oracle October 2010 - April 2011
DEKRA Certification B.V. June 2008 - April 2010
Markem-Imaje October 2007 - February 2008
Vadosity Inc March 2004 - January 2005
Thermo - Material Charaterization May 2003 - February 2004
FCI Framatome Connectors November 2001 - March 2003
Thuringia Consulting, Inc. September 2000 - October 2001
GLT Gesellschaft für Löttechnik mbh November 1999 - June 2000
Global One September 1998 - September 1999
Skills
CRM, Business Process, Quality Assurance, Consulting, Technical Support, Business Analysis, Documentation, Oracle, Technical Writing, Lotus Notes, SalesForce, Parature, Feedback Intelligence, FogBugz, Java SE5/SE6, Basic HTML5, SAP CRM, EFM Feedback 6.4, Adobe Illustrator, Adobe PageMaker, Quickbooks, English, German, Lync
Education
University of South Florida 2005 — 2007
Bachelor of Science, International Management
Verint-Systems July 2011 - April 2015
Oracle October 2010 - April 2011
DEKRA Certification B.V. June 2008 - April 2010
Markem-Imaje October 2007 - February 2008
Vadosity Inc March 2004 - January 2005
Thermo - Material Charaterization May 2003 - February 2004
FCI Framatome Connectors November 2001 - March 2003
Thuringia Consulting, Inc. September 2000 - October 2001
GLT Gesellschaft für Löttechnik mbh November 1999 - June 2000
Global One September 1998 - September 1999
Skills
CRM, Business Process, Quality Assurance, Consulting, Technical Support, Business Analysis, Documentation, Oracle, Technical Writing, Lotus Notes, SalesForce, Parature, Feedback Intelligence, FogBugz, Java SE5/SE6, Basic HTML5, SAP CRM, EFM Feedback 6.4, Adobe Illustrator, Adobe PageMaker, Quickbooks, English, German, Lync
Education
University of South Florida 2005 — 2007
Bachelor of Science, International Management
Alexander Dewar Alexander Dewar's DEKRA Certification B.V. Experience October 2014 - Present
Job Admin Assistant at Dekra Certification, Inc.
Industry Graphic Design
Experience
DEKRA Certification B.V. October 2014 - Present
Parkway Cleaners February 2012 - September 2014
Target November 2011 - January 2012
Skills
Illustrator, InDesign, Photoshop, Layout, Graphic Design, Posters, Brochures, Business Cards, Mac, Stationery, OS X, Color Theory, Microsoft Office, Flyers, Adobe Creative Suite, Dreamweaver, Flash, QuarkXPress, Typography
Education
Pennsylvania College of Art & Design 2009 — 2011
Bachelor of Fine Arts, Graphic Design
Montgomery County Community College 2006 — 2009
Associates, Graphic Design
DEKRA Certification B.V. October 2014 - Present
Parkway Cleaners February 2012 - September 2014
Target November 2011 - January 2012
Skills
Illustrator, InDesign, Photoshop, Layout, Graphic Design, Posters, Brochures, Business Cards, Mac, Stationery, OS X, Color Theory, Microsoft Office, Flyers, Adobe Creative Suite, Dreamweaver, Flash, QuarkXPress, Typography
Education
Pennsylvania College of Art & Design 2009 — 2011
Bachelor of Fine Arts, Graphic Design
Montgomery County Community College 2006 — 2009
Associates, Graphic Design
Sarah Honey Stewart Sarah Honey Stewart's DEKRA Certification B.V. Experience April 2013 - March 2015
Job Administrative/Clerical/Office
Industry Executive Office
Experience
DEKRA Certification B.V. April 2013 - March 2015
Beverages and More April 2009 - February 2010
BioZone Laboratories, Inc. June 2003 - April 2008
Jacuzzi Inc January 2003 - June 2003
Kiewit Pacific Co June 2000 - March 2002
CB Richard Ellis August 1999 - January 2000
Hofmann Company February 1999 - August 1999
Jenkins/Athens Insurance Services September 1997 - February 1999
Skills
Outlook, Inventory Management, Microsoft Excel, Microsoft Word, Microsoft Office, PowerPoint, Sales, Customer Satisfaction, Travel Arrangements, Marketing, Proposal Writing, File Management, Shipping, Cpr Certified, Telephone Skills, Retail, Access
Education
Heald College 2010 — 2012
Business Administration
Antioch High School 1993 — 1996
High School Diploma, General Education
DEKRA Certification B.V. April 2013 - March 2015
Beverages and More April 2009 - February 2010
BioZone Laboratories, Inc. June 2003 - April 2008
Jacuzzi Inc January 2003 - June 2003
Kiewit Pacific Co June 2000 - March 2002
CB Richard Ellis August 1999 - January 2000
Hofmann Company February 1999 - August 1999
Jenkins/Athens Insurance Services September 1997 - February 1999
Skills
Outlook, Inventory Management, Microsoft Excel, Microsoft Word, Microsoft Office, PowerPoint, Sales, Customer Satisfaction, Travel Arrangements, Marketing, Proposal Writing, File Management, Shipping, Cpr Certified, Telephone Skills, Retail, Access
Education
Heald College 2010 — 2012
Business Administration
Antioch High School 1993 — 1996
High School Diploma, General Education
Connie (O'Connor) Del Buono Connie (O'Connor) Del Buono's DEKRA Certification B.V. Experience January 2006 - August 2014
Job Founder, Director Regulatory and Compliance at Synoptyx Inc.
Industry Medical Devices
Experience
Synoptyx Inc. August 2014 - Present
DEKRA Certification B.V. January 2006 - August 2014
ImmunoConcepts N. A. Ltd 1993 - January 2006
Immuno Concepts, Inc. April 1983 - October 1993
Skills
Medical Devices, IVDs, GMP, ISO 13485, Quality Management, 21 CFR 820, 21 CFR Part 11, CAPA, Canadian MDR, Quality System, V&V, Design Control, R&D, FDA, Regulatory Affairs, Biotechnology, Validation, Life Sciences, Regulatory Submissions, Cardiology, Product Launch, Technology Transfer, Commercialization, Supplier Quality, Six Sigma, Software Documentation, Microbiology, Biomedical Engineering, Engineering, Lean Manufacturing, Pharmaceutical Industry, Process Simulation, Lifesciences, Process Engineering, Regulatory Requirements, Management, Project Management, Quality Assurance, Quality Auditing, CE marking, Product Development, Manufacturing, ISO 14971, ISO, Quality Control, Cross-functional Team..., Change Control
Education
State University of New York College at Plattsburgh 1974 — 1978
Bachelor of Arts, Biology, Microbiology concentration
Synoptyx Inc. August 2014 - Present
DEKRA Certification B.V. January 2006 - August 2014
ImmunoConcepts N. A. Ltd 1993 - January 2006
Immuno Concepts, Inc. April 1983 - October 1993
Skills
Medical Devices, IVDs, GMP, ISO 13485, Quality Management, 21 CFR 820, 21 CFR Part 11, CAPA, Canadian MDR, Quality System, V&V, Design Control, R&D, FDA, Regulatory Affairs, Biotechnology, Validation, Life Sciences, Regulatory Submissions, Cardiology, Product Launch, Technology Transfer, Commercialization, Supplier Quality, Six Sigma, Software Documentation, Microbiology, Biomedical Engineering, Engineering, Lean Manufacturing, Pharmaceutical Industry, Process Simulation, Lifesciences, Process Engineering, Regulatory Requirements, Management, Project Management, Quality Assurance, Quality Auditing, CE marking, Product Development, Manufacturing, ISO 14971, ISO, Quality Control, Cross-functional Team..., Change Control
Education
State University of New York College at Plattsburgh 1974 — 1978
Bachelor of Arts, Biology, Microbiology concentration
Rudolf Pommé's DEKRA Certification B.V. Experience August 2005 - April 2013
Job Operational Manager Explosion Safety North America at DEKRA Certification Group
Industry Public Safety
Experience
DEKRA Certification Group April 2013 - Present
DEKRA Certification B.V. August 2005 - April 2013
Thermon Europe BV 1995 - 2005
Thermon Europe B.V. 1995 - 1999
Skills
Engineering, Testing, Manufacturing, Quality System, ATEX, ISO, CE marking, Quality Management, Instrumentation, Electricians, Energy, Inspection, Project Management, Project Engineering, Product Development, Electrical Engineering, Electronics, Automation, Continuous Improvement, Process Engineering, Commissioning, Quality Assurance, Process Control, Management
Education
Hogeschool Rotterdam 1989 — 1995
Bachalor of Science, Applied Physics and Business Administration
DEKRA Certification Group April 2013 - Present
DEKRA Certification B.V. August 2005 - April 2013
Thermon Europe BV 1995 - 2005
Thermon Europe B.V. 1995 - 1999
Skills
Engineering, Testing, Manufacturing, Quality System, ATEX, ISO, CE marking, Quality Management, Instrumentation, Electricians, Energy, Inspection, Project Management, Project Engineering, Product Development, Electrical Engineering, Electronics, Automation, Continuous Improvement, Process Engineering, Commissioning, Quality Assurance, Process Control, Management
Education
Hogeschool Rotterdam 1989 — 1995
Bachalor of Science, Applied Physics and Business Administration