Position:
Expert Advisor at Legal and at Various Consulting Firms and Groups
Work:
Various Consulting Firms and Groups
- Global since Mar 2010
Expert Advisor at Legal and
Fresenius Medical Care
- Walnut Creek Aug 2012 - Mar 2013
Quality Systems Consultant
Other recent experiences
- CA and IN Aug 2011 - Apr 2012
Validations Quality Consultant
Edwards Lifesciences Research Medical, Salt Lake City area
Jan 2010 - 2010
R&D Consultant
Stryker Endoscopy
2008 - 2009
Compliance and Principal Validations Consultant, San Jose
GE Healthcare OEC
2007 - 2008
QA and Validations Consultant, Salt Lake City area
Curon Medical
2005 - 2007
Consultant-Managing Director QA/RA
Accellent Cardiology
- Tehachapi, CA 2004 - 2005
Consulting Quality Manager
Sanmina SCI
2002 - 2004
Regulatory Compliance Officer
SaRonix
- Menlo Park, CA Sep 1999 - Nov 2002
Director - Worldwide QA and Reliability
Orthopedic Systems
- Union City Mar 1993 - Oct 1999
Quality Manager
NovaSensor
1988 - 1993
Quality Systems Director
Education:
San Jose State University
BS, Quality, Reliability, Regulatory, Medical Devices, Business
Skills:
FDA, Validation, CAPA, Medical Devices, Risk Management, ISO 13485, QSR, MDD, Reliability Engineering, 21 CFR 820 QSR, Regulatory Compliance, Regulatory Affairs, Sop, V&V, Quality Management, Quality System, Design Control, Quality Assurance, Medical Device Directive, GMP, Components, Compliance, R&D
