QA/QC Manager

QA/QC Manager | Medical Devices | Eindhoven

Introduction

A medtech company based in Eindhoven is entering a defining phase: the transition to commercial operations and FDA Pre-Approval Inspection (PAI) readiness. To lead this journey, they are looking for an experienced QA/QC Manager who can own both the Quality Management System and the Quality Control function. This is not a maintenance role. This is a build-and-scale opportunity for someone who thrives in complex, high-stakes environments and knows what inspection-ready truly means.

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 maintaining the QMS in full compliance with 21 CFR 820, ISO 13485, and EU MDR
• Driving FDA and Notified Body inspection readiness, including mock audits
• Leading the QC function: incoming, in-process, and final inspection, batch review and product disposition
• Managing the CAPA system with a focus on robust root cause analysis and timely closure
• Chairing the Change Control Board (CCB) and ensuring cross-functional impact assessment
• Overseeing nonconformance management and clear escalation pathways
• Driving the Management Review process with meaningful KPIs and actionable outputs
• Providing QA oversight to Design Assurance and Design Controls (DHF/DMR/DHR alignment)
• Leading continuous improvement and scalability of QMS and QC processes
• Acting as the primary inspection interface for FDA and Notified Body audits

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
• 3+ years of people management experience
• Comfortable operating in a fast-growing, pre-commercial environment
• Hands-on, structured, and able to balance compliance with operational pace

What's on Offer

• A gross annual salary between €60,000 and €100,000 a year, depending on experience
• A critical leadership role at a pivotal commercial stage
• The opportunity to build and scale a fully compliant, inspection-ready QA/QC organisation
• Work with cutting-edge Class III medical technology entering commercialisation
• A driven, mission-led team in an innovative medtech environment in Eindhoven
• Competitive secondary employment conditions in line with seniority

About the Company

This company is a clinical-stage medtech company based in Eindhoven, developing a new generation of implantable cardiovascular devices. Their proprietary technology enables the patient's own body to naturally regenerate living blood vessels and heart valves, replacing synthetic implants over time. 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. A compact, focused team. Real impact. A genuine mission.