Accomplished RAC professional with substantial regulatory, standards, quality and design assurance expertise.  Thirty years experience in the complex Medical Device and Nuclear Products industry.

Titles Held: Senior Manager of Design Assurance; Director of Design Assurance; Senior Manager of Design Quality Assurance; System Qualification Manager

• Product Development lifecycle, product design compliance to the QSR and MDD, as well as best practices for speed and effectiveness
• Skilled in all areas of Design Assurance such as product risk analysis including software, product design, process validation, process software validation, equipment commissioning and equipment servicing
• Full understanding of ISO 13485, MDD, technical standards, conformance and regulations for EU, Japan and Australia
• Senior Manager experienced with MDR’s and recall decision making as well as product safety
• Face to face experience with FDA and ISO audits the as well as back room support including recovery from Warning Letters