Quality Assurance Manager

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

On‑site presence

in Eindhoven is essential (fully remote not possible)

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.

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