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Head of Design Quality Assurance (f/m/d)
Fresenius Medical Care đŽđš Palazzo Pignano, Cremona, Italy
Lead the global Design Quality Assurance organization, setting its strategy and ensuring consistent, compliant design control across the In Center product portfolio. Provide expert oversight of development programs, design reviews and regulatory readiness while harmonizing processes and coordinating with R&D, Regulatory Affairs, Manufacturing, and Quality teams.
Responsibilities
- Lead the global Design Quality Assurance organization, setting its strategy and ensuring consistent, compliant design control across the In Center product portfolio. Provide expert oversight of development programs, design reviews and regulatory readiness while harmonizing processes and coordinating with R&D, Regulatory Affairs, Manufacturing, and Quality teams.
Requirements
- Requires a university degree in engineering, medical technology, natural sciences, or a comparable technical field, at least eight years of medical device industry experience, five years in Design Quality Assurance or a related function, and three years of leadership experience. Candidates should have advanced design control expertise, knowledge of FDA quality system requirements, NMPA, EU MDR, and ISO 13485, and fluent English; German is an advantage.
Benefits
- Professional Development
- Career Planning Opportunities
- Innovative Corporate Culture
Key Skills
About Fresenius Medical Care
Fresenius Medical Care is the worldâs leading provider of products and services for individuals with renal diseases. We aim to create a future worth living for chronically and critically ill patients â worldwide and every day. Thanks to our decades of experience in dialysis, our innovative research and our value-based care approach, we can help them to enjoy the very best quality of life. Our portfolio encompasses a comprehensive range of high-quality health care products and services as well as various dialysis treatment options for both in-center and home dialysis that are individually tailored to our patientsâ needs.
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