Our client is a MedTech company based in the Frankfurt region, currently restructuring its global quality organisation. They are looking for a Head of Quality to build a company-wide QA function, drive continuous improvement, and ultimately integrate Quality Assurance and Quality Management into a single, effective quality organisation.

The role

In this position, you will lead the transformation of the Quality Assurance function from an operations-focused control team into a company-wide quality partner to Operations, R&D, Service, and the field. Over time, you will assume responsibility for both QA and Quality Management, shaping processes, driving root cause analysis, and acting as a change leader for a stronger quality culture across the company.

Key responsibilities

• Establish and lead a company-wide Quality Assurance function, moving QA out of Operations into a central role.
• Define QA strategy, priorities, and structure to cover Operations, Service/field, and R&D interfaces.
• Ensure effective incoming goods inspection and in-process controls, with appropriate quality criteria and control plans.
• Drive robust root cause analysis (e.g. 8D, 5-Why) and ensure corrective and preventive actions lead to sustainable quality improvements.
• Implement systematic feedback loops from field/service issues back into Operations, R&D, and suppliers.
• Set up and manage quality control and validation across development milestones, including verification/validation activities in collaboration with R&D.
• Over time, integrate Quality Assurance with Quality Management into one organisation and take ownership of the combined function.
• Oversee and further develop the quality management system, including processes, documentation, and relevant QM roles (e.g. QMB, PRRC as applicable).
• Act as a sparring partner to R&D and Operations on quality topics, challenging and aligning on quality criteria and standards.
• Promote a culture of continuous improvement, questioning the effectiveness of existing processes rather than focusing only on formal compliance.
• Lead, develop, and restructure a combined QA/QM team of ~16–20 people, including succession planning and role adjustments.

Required experience and qualifications

• Several years of experience in Quality within the medical device / MedTech industry.
• Proven experience in both Quality Assurance/Quality Control and Quality Management (not only one side).
• Demonstrated track record in leading and developing quality teams, ideally through change and organisational transformation.
• Strong experience with root cause analysis, CAPA, and implementing sustainable quality improvements.
• Familiarity with quality requirements across the product lifecycle, including development, industrialisation, operations, and field/service.
• Experience collaborating closely with R&D on quality criteria, validation, and design transfer.
• Continuous improvement mindset, with the ability to challenge and optimise existing processes.
• German language skills are a strong advantage; English is required.

Why this role?

• Play a central role in reshaping the company’s entire quality organisation and strategy.
• Lead a sizeable quality team and have a direct impact on how quality is managed across Operations, R&D, and Service.
• Join a financially stable MedTech company with long-term perspective and executive sponsorship for change.