Ensure the conformity of product development according to the applicable documents (standards, directives, procedures, quality plan);
Adapt the quality requirement level and the application of procedures according to the product classification (e.g., rigor of IEC 60601-1-11 for medical assistance products vs. agility for research/professional products);
Ensure the proper application of all procedures and standards necessary for the development and preparation for production of products;
Ensure product conformity with applicable standards and regulations, from the development of the certification plan to the final technical file, by overseeing conformity assessments and external testing follow-up;
Lead the product risk management process in accordance with ISO 14971 (or relevant industrial standards), from the plan development to the final report writing, by conducting ...