Stan Mastrangelo

Stan Mastrangelo, Professor, Center for Applied Health Sciences, Virginia Tech University has 30 years professional work experience with 27 years in management positions in medical device, food, and pharmaceutical industries. He has held positions such as a Senior Quality Engineer, Corporate Quality Assurance Auditor, Plant QA Manager, and QA Director at Abbott Laboratories. Stan was a member of the ANSI Executive Standards Board. Stan has been a member of the ISO Joint Working Group for Risk Management of Medical Devices (that developed ISO/IEC14971).

Stan is a committee liaison to the ISO Technical Management Board Joint Working Group on Risk Management developing ISO 31000. This group is developing a Risk Management Standard applicable to a wide range of organizations including industry, government, and non-profit organizations. Stan was on the US PhRMA team that supported the development of ICH Q9 Quality Risk Management for Pharmaceuticals. Stan is also involved in TC 215 JWG7 Risk Management of IT-Networking Medical Devices and a liaison to JWG 3 Software Lifecycle Risk Management.

Stan is a frequent speaker for Medical Device and Pharmaceutical industry organizations and has been faculty for organizations such as AAMI (American Ass. for the Advancement of Medical Instrumentation), Advamed,, ASQ, and CPT (Center for Pharmaceutical Training). Stan has been active developing and implementing a Graduate Certificate Program and a Master's of Science Degree Program in Risk Management for the Healthcare Manufacturing Industry at Virginia Tech.