- In the medical device industry since 1988; product experience includes intraocular lenses, in vitro diagnostics, embedded software, orthobiologic products, animal origin materials. Held positions as Chemist, Microbiologist, QC Lab Manager and QA Manager in FDA-regulated firms.
- Independent Quality System Consultant since February 2002.
- Former notified body (TÜV Product Service) Medical Auditor for the Medical Device and IVD Directives. Audited manufacturers of catheters, ultrasound devices, glucose meters, stents, prosthetic implants, dialysis equipment and other medical devices and IVDs for ISO 13485, MDD and IVDD certification/CE marking. Reviewed technical files.
- Health Canada-Certified as an auditor for CMDCAS-recognized audit teams.
- Trained on 510(k) review by Third Party Reviewer (TÜV Product Service).
- Master's Degree in Molecular Biology/Biochemistry (University of California, Santa Barbara).
- Bachelor's Degree in Biology (Santa Clara University, Santa Clara, CA).
- Student of Charles Bamforth, PhD and Michael Lewis, PhD, Intensive Brewing Science for Practical Brewing, Brewing Technology at University of California, Davis.
- ASQ Certified Biomedical Quality Auditor (CBA).
- Member of ASQ (American Society for Quality).
- Former Co-Chair of the Northern California ASQ Biomedical Discussion Group.
- Frequent speaker or moderator at Northern California ASQ Biomedical Discussion Group events.
- Member of RAPS (Regulatory Affairs Professional Society).
- Philosophies on Quality Systems: keep it simple, learn from others mistakes, focus on value added to the business.