Unity Partners exclusively on behalf of our MedTech partner
We have been retained by a fast-growing medical technology scale-up in their search for a hands-on Quality Assurance Manager. This company develops an innovative medical device that combines both hardware and software elements, serving a global healthcare audience.
As the hands-on QA Manager, you’ll play a key role in managing and maturing the Quality Management System (QMS), acting as a strategic and operational leader for all quality topics. You will also potentially serve as the PRRC under MDR — ensuring product safety, audit readiness, and continuous improvement as the company moves from scale-up to commercialization.
This is an on-site role in Eindhoven, ideal for professionals seeking ownership, autonomy, and a direct impact in a fast-growing company with an international team and ambitious mission.
As QA Manager, you will:
- Own and evolve the QMS (ISO 13485), ensuring alignment with MDR and FDA requirements
- Potentially act as PRRC, taking responsibility for product conformity and compliance documentation
- Prepare and lead audits (internal and external), manage CAPAs, NCRs, and SOP improvements
- Collaborate closely with RA, R&D, Operations, and suppliers to embed QA across the product lifecycle
- Oversee technical documentation, product release processes, and post-market surveillance.
- Liaise with leadership on compliance risks, quality reporting, and continuous improvement plans
- Act as sparring partner within the team — balancing structure with scale-up pragmatism
Your Profile:
- 5+ years of experience in QA/QMS for medical devices (hardware and/or SaMD)
- Experience as PRRC under MDR is a pre or strong readiness to take this responsibility
- Solid understanding of ISO 13485, MDR, FDA, and related quality frameworks
- Comfortable navigating ambiguity and creating structure in fast-moving environments
- Strong communicator, natural collaborator, and pragmatic problem-solver
- Experience with data security / ISO 27001 is a plus
- Fluent in English; Dutch not required
- On-site presence in Eindhoven is essential (fully remote not possible)
Why join?
- Be part of a MedTech company that's making real impact in patient care
- Play a pivotal role in shaping the QA/QMS function from the inside out
- Join a diverse and informal team with short lines, speed, and ambition
- Salary based on experience, plus additional benefits including stock appreciation rights
- 25 holidays (with option to buy more), good pension scheme, and training opportunities
Interested?
Let’s connect. Unity Partners is exclusively supporting this confidential search.