Head of Design Quality Assurance

At Fresenius Medical Care, we are the global leader in kidney care, committed to improving the lives of patients with chronic kidney disease. Our mission is to deliver high-quality, innovative products, services, and care across the entire healthcare journey. Guided by our vision — “Creating a future worth living. For patients. Worldwide. Every day.” — we work with purpose and compassion, supported by a global team of over 110,000 employees. Within our Care Enablement segment, we develop and provide life-sustaining medical products, digital health solutions, and therapies that empower clinical teams and improve patient outcomes. Our FME Reignite strategy drives transformation through innovation, efficiency, and sustainable growth. Our values guide how we work:
* We Care for our patients, each other, and our communities
* We Connect across teams and borders to deliver excellence together
* We Commit to doing things the right way — growing with purpose and leading kidney care with integrity and innovation In your role as Head of Design Quality Assurance (f/m/d) you will be responsible for disciplinary and functional leadership of the Design Quality Assurance (DQA) group within the System, Quality & Regulatory – In Center Product Quality & CE Supplier Quality Department. The Head of Design Quality Assurance (DQA) is responsible for the global leadership and coordination of all Design Quality Assurance activities across the entire product portfolio of In Center
- including active and non-active medical devices. This role ensures consistent and compliant execution of design control processes for all development and change projects, supporting regulatory readiness and quality by design. The role combines disciplinary leadership, functional strategy and hands-on expert guidance, overseeing a globally distributed team across the US, Mexico, Europe, and China. The position acts as a critical interface between development, regulatory, manufacturing and quality functions, ensuring a harmonized and effective approach to design assurance on a global scale. Your tasks Organizational and functional leadership
* Provide global disciplinary and functional leadership to the DQA organization, including resource planning, competency development, performance management and team development
* Define and implement the global DQA strategy and operating model, ensuring consistent Design Quality execution across product lines, technologies and regions
* Represent Design Quality in global leadership forums, development governance and strategic cross-functional decision-making Design Quality & Development Oversight
* Provide senior technical quality leadership and expert guidance for medical device product development and design change projects
* Ensure compliant execution of Design Controls, including requirements management, design verification and validation, design reviews, design transfer, traceability and DHF completeness.
* Provide independent quality assessments of development strategies, Design Control approaches and project deliverables, ensuring compliance with applicable regulatory and internal requirements
* Oversee Design Quality reviews and approvals at project milestones, Quality Gates and phase exits, ensuring appropriate identification and escalation of compliance risks Process Harmonization & Regulatory Compliance
* Drive global harmonization, implementation and continuous improvement of Design Control processes in close collaboration with R&D, global Process Owners and Quality functions
* Assess the impact of new or revised Quality and regulatory requirements on development projects and define appropriate implementation strategies, priorities and resource needs
* Lead and support Design Control remediation, regulatory inspection readiness and compliance improvement initiatives, ensuring effective and sustainable implementation of corrective actions Global Program & Stakeholder Management
* Provide strategic Design Quality oversight for global development programs and high-priority Design Quality initiatives, ensuring alignment of quality objectives, resources and project priorities
* Guide Design Quality Functions in complex technical and regulatory decisions and collaborate with R&D, Regulatory Affairs, Product Quality, Manufacturing and Supplier Quality to ensure effective project execution and design transfer

Your profile
* Successfully completed university degree in engineering, medical technology, natural sciences or a comparable technical field
* Minimum 8 years of professional experience in the medical device industry, including at least 5 years of practical experience in Design Quality Assurance, Design Controls or a comparable development-related Quality function
* Minimum 3 years of leadership experience, preferably including disciplinary and functional leadership within an international or matrix organization
* Advanced practical knowledge of Design Controls throughout the development lifecycle, includin