The Medical Device and Packaging QA Staff (Advisor) should have minimum 2 years practical experience in medical devices R&D Quality: design controls, new product development life cycle, requirement specifications, risk management (including FMEA), validation / verification (V&V), usability / human factor studies, DHFs, design transfer. This role assures product development and site level execution of the local CP/MD Quality System for combination products to govern quality related business processes throughout the entire combination product lifecycle, with emphasis on the new product development activities.