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

<p>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.</p><br /><p>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.</p><br /><p>Our values guide how we work:</p><ul><li>We Care for our patients, each other, and our communities</li><li>We Connect across teams and borders to deliver excellence together</li><li>We Commit to doing things the right way — growing with purpose and leading kidney care with integrity and innovation</li></ul><br /><p>In your role as <b>Head of Design Quality Assurance</b> (f/m/d) you will be responsible for disciplinary and functional leadership of the Design Quality Assurance (DQA) group within the System, Quality &amp; Regulatory – In Center Product Quality &amp; CE Supplier Quality Department.  </p><p> </p><p>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. </p><p> </p><p>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.</p><br /><p><b>Your tasks</b></p><p>Organizational and functional leadership</p><ul><li>Provide global disciplinary and functional leadership to the DQA organization, including resource planning, competency development, performance management and team development</li><li>Define and implement the global DQA strategy and operating model, ensuring consistent Design Quality execution across product lines, technologies and regions</li><li>Represent Design Quality in global leadership forums, development governance and strategic cross-functional decision-making</li></ul><br /><p>Design Quality &amp; Development Oversight</p><ul><li>Provide senior technical quality leadership and expert guidance for medical device product development and design change projects</li><li>Ensure compliant execution of Design Controls, including requirements management, design verification and validation, design reviews, design transfer, traceability and DHF completeness.</li><li>Provide independent quality assessments of development strategies, Design Control approaches and project deliverables, ensuring compliance with applicable regulatory and internal requirements</li><li>Oversee Design Quality reviews and approvals at project milestones, Quality Gates and phase exits, ensuring appropriate identification and escalation of compliance risks</li></ul><br /><p>Process Harmonization &amp; Regulatory Compliance</p><ul><li>Drive global harmonization, implementation and continuous improvement of Design Control processes in close collaboration with R&amp;D, global Process Owners and Quality functions</li><li>Assess the impact of new or revised Quality and regulatory requirements on development projects and define appropriate implementation strategies, priorities and resource needs</li><li>Lead and support Design Control remediation, regulatory inspection readiness and compliance improvement initiatives, ensuring effective and sustainable implementation of corrective actions</li></ul><p> </p><p>Global Program &amp; Stakeholder Management</p><ul><li>Provide strategic Design Quality oversight for global development programs and high-priority Design Quality initiatives, ensuring alignment of quality objectives, resources and project priorities</li><li>Guide Design Quality Functions in complex technical and regulatory decisions and collaborate with R&amp;D, Regulatory Affairs, Product Quality, Manufacturing and Supplier Quality to ensure effective project execution and design transfer</li></ul><br /><p><b>Your profile</b></p><ul><li>Successfully completed university degree in engineering, medical technology, natural sciences or a comparable technical field</li><li>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</li><li>Minimum 3 years of leadership experience, preferably including disciplinary and functional leadership within an international or matrix organization</li><li>Advanced practical knowledge of Design Controls throughout the development lifecycle, including requirements management, risk management, design verification and validation, design reviews, design transfer, traceability and DHF documentation</li><li>Demonstrated expertise in quality by design principles and their application throughout the product development lifecycle, including FMEA, design outputs and design transfer</li><li>Proven experience in Design Control process implementation, harmonization, remediation or continuous improvement within a regulated medical device environment</li><li>Strong knowledge of applicable medical device regulations and standards, particularly FDA Quality System requirements, NMPA and EU MDR, ISO 13485</li><li>Experience with regulatory inspections, audits and development-related compliance remediation activities is an advantage</li><li>Demonstrated ability to independently assess complex development and compliance topics, challenge technical approaches and translate regulatory requirements into effective development strategies and processes</li><li>Strong strategic and analytical capabilities, with proven ability to drive cross-functional decisions and manage competing priorities in complex development environments</li><li>Strong stakeholder management and communication skills, with the ability to drive alignment and facilitate cross-functional decisions at senior management level</li><li>Fluent in English, German language is an advantage</li></ul><br /><p><b>Our offer for you</b></p><p>There is a lot you can discover at Fresenius Medical Care, regardless of which field you are an expert and how much experience you have - all dedicated to your professional journey.</p><p> </p><ul><li>Whether in front of or behind the scenes - you are helping to make ever better medicine available to more people around the world</li><li>Individual opportunities for self-determined career planning and professional development</li><li>A corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest one</li><li>Many committed people with a wide range of skills, talents and experience</li><li>The benefits of a successful global corporation with the collegial culture of a medium-sized company</li></ul><p><i> </i></p><p><i><b>We are committed to diversity and equal opportunities and welcome applications from people with disabilities.</b></i></p>