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

Fresenius Medical Care AG; Bad Homburg vor der Höhe; Vor Ort; EUR 120.000 - 160.000; Vollzeit

Benefits dieser Stelle

Career development

Self-determined career planning

Innovative culture

Global company benefits

Collegial culture

Zusammenfassung

Fresenius Medical Care seeks a Head of Design Quality Assurance to lead a global DQA team responsible for design controls, risk management and regulatory readiness across its product portfolio in center-based therapies.

You will oversee cross‑functional collaboration with R&D, Regulatory, Manufacturing and Quality, ensuring harmonized execution of design assurance on a worldwide scale. Fluent English is essential; German is a plus.

Qualifikationen

• Minimum 8 years in the medical device industry with at least 5 years in Design Quality Assurance, Design Controls or similar quality function.
• Proven leadership experience in an international or matrix organization.
• Strong knowledge of Design Controls, risk management and DHF documentation.

Aufgaben

• Provide global disciplinary and functional leadership to the DQA organization, including resource planning and performance management.
• Define and implement the global DQA strategy and operating model across product lines and regions.
• Represent Design Quality in global leadership forums and program governance.
• Provide senior technical quality leadership for product development and design change projects.
• Ensure compliant execution of Design Controls: requirements, verification/validation, reviews, transfer and DHF completeness.
• Offer independent quality assessments of development strategies and project deliverables.
• Oversee Design Quality reviews and milestones, with escalation of compliance risks.
• Harmonize Design Control processes with R&D, Process Owners and Quality functions.
• Lead remediation and regulatory inspection readiness initiatives and continual improvement of quality actions.
• Provide strategic oversight for global development programs and cross-functional alignment.

Kenntnisse

Leadership

Design Quality

Regulatory Knowledge

Design Controls

Strategic Thinking

Cross-functional

Quality by Design

English Fluent

Ausbildung

Engineering or related technical degree

Jobbeschreibung

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 theSystem, Quality & Regulatory – In Center Product Quality & CE Supplier Quality Department.

The Head of Design Quality Assurance (DQA)is responsible forthe global leadership and coordination of all Design Quality Assurance activities across the entire product portfolioof In Center - including active and non-active medicaldevices. 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, including requirements management, risk management, design verification and validation, design reviews, design transfer, traceability and DHF documentation
• Demonstrated expertise in quality by design principles and their application throughout the product development lifecycle, including FMEA, design outputs and design transfer
• Proven experience in Design Control process implementation, harmonization, remediation or continuous improvement within a regulated medical device environment
• Strong knowledge of applicable medical device regulations and standards, particularly FDA Quality System requirements, NMPA and EU MDR, ISO 13485
• Experience with regulatory inspections, audits and development‑related compliance remediation activities is an advantage
• Demonstrated ability to independently assess complex development and compliance topics, challenge technical approaches and translate regulatory requirements into effective development strategies and processes
• Strong strategic and analytical capabilities, with proven ability to drive cross‑functional decisions and manage competing priorities in complex development environments
• Strong stakeholder management and communication skills, with the ability to drive alignment and facilitate cross‑functional decisions at senior management level
• Fluent in English, German language is an advantage

Our offer for you

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.

• Whether in front of or behind the scenes - you are helping to make ever better medicine available to more people around the world
• Individual opportunities for self‑determined career planning and professional development
• A corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest one
• Many committed people with a wide range of skills, talents and experience
• The benefits of a successful global corporation with the collegial culture of a medium‑sized company

We are committed to diversity and equal opportunities and welcome applications from people with disabilities.