18+ years of experience in the medical device industry.Experience in setting up and maintaining a Quality Management System according to ISO 13485, EU MDR 2017/745, and ISO 9001.Experience in Medical Device Development Processes, primarily in the area of Product Development. Expertise spans various disciplines, including hands-on product development, employee coaching and development, organizational change. As well as solid basis in Design Management, Quality Management and a clear focus on interaction between customer and company.Area of work is in Medical Device Industry and mechanical precision industry.Specialties: - Setting up and maintaining a Quality Management System according to ISO 13485, EU MDR 2017/745 and ISO 9001.- Design Control including obtaining CE - Design Management- Risk Management according to ISO 14971- Project Management- Coaching/training