Quality Assurance Manager

Unity Partners exclusively on behalf of our MedTech partner

Lijkt deze vacature u wat? Solliciteer dan snel, want er wordt een groot aantal sollicitaties verwacht. Scroll naar beneden om de volledige functieomschrijving te lezen. 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 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. xjpvoyz Unity Partners is exclusively supporting this confidential search.