Proven knowledge and experience (ideally minimum 4 years) of working with ISO 13485, ISO 14971, the Medical Device Directive, EU Medical Device Regulation 2017/745 and the FDA QSR including 21 CFR Part 820 and 21 CFR Part 11, ideally gained in the medical device industry. This encompasses, but is not limited to, process and supplier validation, supplier change requests, non-conforming product issues, risk assessment, the Cook Polymer Technology Corrective and Preventive Action (CAPA) program, and associated Quality System documentation.