Mary Sigourney

Mary Sigourney has over 25 years of experience in Quality Management in In vitro diagnostics in both large, multi-national companies and start-up organizations. She has been responsible for regulatory compliance activities including the development of internal and supplier audit programs, design control systems, document control programs and CAPA systems. Ms. Sigourney has successfully implemented ISO 9001/13485 Quality Systems in several companies and has provided ongoing support to both US- and European-based facilities. She has played an active role in product development and risk management programs for reagent, instrumentation and software systems. She is an active member of ASQ, RAPS, AACC and ISPE and served as past section chair for the Golden Gate section of ASQ.