A medtech company based in Eindhoven is entering the most consequential chapter in its journey: the transition from clinical innovation to commercial operations. They are looking for an experienced QA/QC Manager to own the full quality ecosystem. QA, QC, and QMS. Including the preparation for FDA Pre-Approval Inspection (PAI) and commercial launch. This is not a maintenance role. You will build, challenge, and scale a fully compliant, inspection-ready quality organisation. In close collaboration with R&D, Operations, Regulatory Affairs, and Clinical teams.
About the Role
As QA/QC Manager, you carry full accountability for both QA oversight and QC execution. You report directly to the Director of Quality and manage a team of QA professionals, Document Control, and QC technicians.
Your key responsibilities include:
- Owning and continuously strengthening the QMS in full compliance with 21 CFR 820, ISO 13485, and EU MDR
- Driving FDA and Notified Body inspection readiness, including mock audits and acting as primary inspection interface
- Leading the QC function: incoming, in-process, and final inspection, batch review and product disposition aligned with DMR/DHR requirements
- Managing the CAPA system end-to-end. Robust root cause analysis, timely closure, and escalation control
- Chairing the Change Control Board (CCB) with strong linkage to ISO 14971 risk management and design documentation
- Overseeing nonconformance management and clear escalation pathways
- Providing QA oversight of design controls and R&D activities, ensuring DHF/DMR/DHR traceability
- Driving the Management Review process with meaningful KPIs, trend analysis, and actionable outputs
- Overseeing document control, training compliance, and GMP standards across the organisation
- Driving continuous improvement and scalability across QMS and QC processes
Qualifications
- 7+ years of experience in medical device Quality (QA and/or QC)
- Solid working knowledge of 21 CFR 820, ISO 13485, and EU MDR
- Experience with Class II/III medical devices
- Background in both R&D/design control environments and manufacturing/cleanroom operations
- Expertise in CAPA, nonconformance, change control, and product release processes
- Strong grasp of design controls (21 CFR 820.30) and ISO 14971 risk management
- Understanding of DHF, DMR, and DHR traceability
- Experience with supplier qualification and validation
- 3+ years of people management experience
- Hands-on, structured, and able to balance compliance with operational pace
- You don't wait for structure to exist before you start creating it
What's on Offer
- A gross annual salary between €60,000 and €100,000, depending on experience
- A critical leadership role at a genuinely rare moment. Breakthrough Class III technology, a clear FDA regulatory path, and a commercial transition happening now
- The scope and seniority to shape how quality scales as the company grows globally
- Work with technology that has real patient impact
- A driven, mission-led team of around 60 people on the TU/e campus in Eindhoven. One of Europe's leading high-tech ecosystems
- Competitive secondary employment conditions in line with seniority
About the Company
This company is a clinical-stage medtech company based in Eindhoven, pioneering restorative cardiovascular implants. Devices engineered to transform into the patient's own living tissue. Their proprietary technology enables the body to naturally regenerate living blood vessels and heart valves. With an FDA Breakthrough Device Designation and active pivotal trials underway in both Europe and the US, they are at the forefront of restorative cardiovascular medicine. Quality is not a support function here. It is the foundation everything is built on.
.png)
