Quality Assurance Manager

Quality Assurance Manager - Unity Partners - Vacatures

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 serve as the Person Responsible for Regulatory Compliance (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.

·       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

·      5+years of experience in QA/QMS for medical devices (hardwareand/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)

·      Be part of a MedTech company that's making real impact in patient monitoring and 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

Let’s connect. Unity Partners is exclusively supporting this confidential search.

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