A highly skilled, International Quality veteran and effective leader with twenty-eight years experience in the Global Quality Movement.  Ability to employ a variety of quality methodologies required to support international technical and regulatory requirements.

Titles Held: Senior Consultant; Director of Quality; Quality Manager; General Manager; Project Manager of Reliability; Quality Engineer.

• Extensive experience with implementation, auditing, certification, and maintenance of ISO 13485:2003, ISO 9001:2000, 21CFR820 cGMP, MDD 93/42/EEC, TL, QS, TS, and several other standards
• Expert in international medical device product registrations for global projects from around the world, including: EU CE notified body marking for class II and class III products, China SFDA, Australia TGA , Brazil, Mexico, Canada CMDR / CMDCAS / CAMCAS, Central and South America, Russia device registration and Japan MGLW
• Skilled at creating and updating FMEAs under ISO 14971 risk management, fault trees, Mil-STD-1629, AIAG FMEA, and other risk methods for Hazard Based Safety Engineering
• Experience in the submission of technical files and product dossiers, pre-market notification and device licensing submissions; Canadian Licenses, FDA 510(k) Approvals & PMA Submissions
• Current ASQ certificates, several considered equivalent to a PE license; fluent in Spanish