About Xeltis

Xeltis is a clinical-stage MedTech company pioneering restorative cardiovascular implants. Devices engineered to transform into the patient's own living tissue. Based in Eindhoven, we are entering the most consequential chapter in our journey: the transition from clinical innovation to commercial operations.

Our technology is Class III. Our regulatory path runs through both the FDA and EU MDR. And quality is not a support function here, it is the foundation everything is built on.

The role

We are looking for an experienced Quality Manager to own the full quality ecosystem: Quality Assurance (QA), Quality Control (QC), and the Quality Management System (QMS), as Xeltis prepares 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.

What you own

QMS & Regulatory Compliance
Own and continuously strengthen the QMS. Ensure full compliance with 21 CFR 820, ISO 13485, and EU MDR. Drive inspection readiness for FDA and Notified Body audits.

Quality Control & Product Release
Lead incoming, in-process, and final inspection. Own batch review, product disposition, and clear release criteria aligned with DMR/DHR requirements.

CAPA & Nonconformance
Own the CAPA system end-to-end. Robust root cause analysis, timely closure, and escalation control. Oversee all nonconformance management.

Change Control & Risk Management
Lead the Change Control Board (CCB). Cross-functional impact assessment with strong linkage to ISO 14971 risk management and design documentation.

Audit & Inspection Readiness
Plan and execute internal and supplier audits. Lead FDA PAI readiness, mock inspections, and act as primary interface during regulatory inspections.

Design Controls & QA Oversight
QA oversight of design controls and R&D activities. Ensure DHF/DMR/DHR traceability and alignment between risk management and production processes.

Continuous Improvement
Drive simplification and scalability across QMS and QC processes. Own management review: meaningful KPIs, trend analysis, and actionable outputs.

Document Control & Training
Oversee document control and training compliance. Ensure GMP standards and SOPs are maintained across the organisation.

Who you are

You are a hands-on quality leader with a systems and process mindset. You build with the same rigour you apply to compliance. You communicate quality expectations across functions without friction and you hold the line on standards while staying aligned with operational realities.

You have worked in both R&D/design control environments and manufacturing or cleanroom operations. You are comfortable in a fast-growing, pre-commercial organisation. You don't wait for structure to exist before you start creating it.

What you bring

Experience

• 7+ years in medical device quality (QA/QC)

• Class II/III medical device experience

• R&D and design control environments

• Manufacturing and cleanroom operations

• 3+ years people management

Regulatory & technical

• 21 CFR 820, ISO 13485, EU MDR

• CAPA, nonconformance, and change control

• Design controls (21 CFR 820.30)

• Risk management (ISO 14971)

• DHF, DMR, and DHR traceability

• Supplier qualification and validation

Why Xeltis

Xeltis sits at a genuinely rare intersection: breakthrough Class III technology, a clear FDA regulatory path, and a commercial transition that is happening now. This is the moment where quality leadership defines the company's future, not just its compliance record.

You will build and lead a cross-functional QA/QC team, work on technology with real patient impact, and have the scope and seniority to shape how quality scales as Xeltis grows globally. The TUE campus in Eindhoven puts you at the centre of one of Europe's leading high-tech ecosystems.

If this stage of the journey is where you do your best work, we would like to hear from you. Interested? Please apply directly via the button below.