Mark Rutkiewicz

VP, Innovize

Mark Rutkiewicz has managed all areas of quality, product development, regulatory, operations, and business/information systems for Class 1, 2 and 3 medical devices for 30 years. He has designed Quality Management Systems for active and non-active implantables, disposables, combo devices, software and capital systems.

Mark built and rebuilt online integrated corporate-wide quality/business systems. He has a Bachelor of Electrical Engineering from the University of Minnesota, a Masters of Applied Liberal Studies from Hamline University, is a Kellogg Executive Scholar, and holds PE and CMII Certificates.

Since July 2013, Mark has been the VP of Quality at Innovize, a contract manufacturer to over 150 medical device companies. He served as the industry representative on the FDA ENT panel and previously worked for Monteris Medical, St Jude Medical, AGA Medical, Cardiac Science, Envoy Medical and Guidant. Mark is currently writing two books on implementing integrated quality/business systems and processes in medical device companies.