Experienced Quality Professional with a demonstrated history of success working in the medical device industry. Skilled in Quality System Development, Manufacturing and Engineering principles, Employee Development, and FDA/ISO Regulations for Medical Devices. Comprehensive understanding "from A to Z" of Medical Device Development utilizing contract and direct manufacturing, both overseas and domestic and including Class III devices. Strong history of experience in quality assurance and a strong educational background in Biological Sciences capped with a Master of Business Administration (M.B.A.) focused in Brand and Product Management from DePaul University - Charles H. Kellstadt Graduate School of Business.