Ensure product development compliance according to applicable documents (standards, directives, procedures, quality plan);
Ensure the proper application of all procedures and standards required for the development and preparation of production ramp-up;
Ensure product compliance with applicable standards and regulations, from the development of the certification plan to the final technical file, by supervising compliance assessments and monitoring external testing;
Lead the product risk management process in accordance with ISO 14971, from plan development to final report writing, by conducting risk analysis activities (e.g.,HA, dFMECA, pFMECA);
Actively participate in design reviews for manufacturing processes of products under development;
Review and approve test plans and reports required for product verification and validation;