8 – 10 years of experience with in depth knowledge of the regulatory environment for medical devices for globally distributed products: 21 CFR Parts 11, 820, ISO 13485, ISO 14971,Quality systems expert with knowledge of QSR, ISO, MDD, CMDR, MDSAP and MEDDEV requirements. 2. Directly responsible for ongoing execution and improvements to the production unit’s quality system activities, which includes, but not limited to: Corrective & Preventative Action, management controls,, complaint investigations, internal auditing, change control, and document control.