Experience: Minimum 8 years professional experience in the applicable role in medical device industry. Education: Education: Bachelor's /Master's degree preferable in Engineering. Strong understanding of appropriate global medical device regulations, requirements and standards, including FDA’s 21 CFR 820, ISO 13485, EU Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), ISO 14971, ISO 9001, and others. Experience running effective process improvement projects. Demonstrated ability to understand and develop processes. Government/regulatory-body Quality System auditing/inspection experience preferred. Demonstrates considerable knowledge of, and success with performing on, compliance-related projects. Proven experience in Quality Management System processes, including cross sector or business process standardization, ensuring effectiveness and efficiency while maintaining compliance with worldwide regulations. A comprehensive understanding of the diverse worldwide medical device quality regulations. An ability to successfully communicate and educate Quality Management System regulations, policies and strategies to teams at all levels of the organization