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"A designer knows he has achieved perfection not when there is nothing left to add, but when there is nothing left to take away."

— Antoine de Saint-ExupĂ©ry

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Fresenius Medical Care logo

Head of Design Quality Assurance (f/m/d)

Fresenius Medical Care đŸ‡©đŸ‡Ș Bad Homburg vor der Höhe, Hesse, Germany

Onsite Full-time Director

The Head of Design Quality Assurance provides global disciplinary and functional leadership for the DQA organization across the entire product portfolio. This role ensures compliant execution of design controls, drives process harmonization, and acts as a critical interface between development, regulatory, and manufacturing functions.

Responsibilities

  • The Head of Design Quality Assurance provides global disciplinary and functional leadership for the DQA organization across the entire product portfolio. This role ensures compliant execution of design controls, drives process harmonization, and acts as a critical interface between development, regulatory, and manufacturing functions.

Requirements

  • Candidates must hold a university degree in engineering, medical technology, or natural sciences with at least 8 years of experience in the medical device industry. The role requires at least 5 years of practical experience in Design Quality Assurance and 3 years of leadership experience in an international or matrix organization.

Benefits

  • Individual career planning
  • Professional development opportunities
  • Innovative corporate culture
  • Global corporation benefits

Key Skills

Design Quality Assurance Medical device regulations Design controls Process harmonization Regulatory compliance Cross‑functional collaboration Leadership Matrix organization management Project management Risk management Quality Management Systems FDA/EMA standards Engineering documentation Change management Team mentoring

About Fresenius Medical Care

Fresenius Medical Care is the world’s 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 – 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 patients’ needs.

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