Quality Assurance Manager

Unity Partners exclusively on behalf of our MedTech partnerWe 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 requirementsPotentially act as PRRC, taking responsibility for product conformity and compliance documentationPrepare and lead audits (internal and external), manage CAPAs, NCRs, and SOP improvementsCollaborate closely with RA, R&D, Operations, and suppliers to embed QA across the product lifecycleOversee technical documentation, product release processes, and post-market surveillance.Liaise with leadership on compliance risks, quality reporting, and continuous improvement plansAct as sparring partner within the team — balancing structure with scale-up pragmatismYour 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 responsibilitySolid understanding of ISO 13485, MDR, FDA, and related quality frameworksComfortable navigating ambiguity and creating structure in fast-moving environmentsStrong communicator, natural collaborator, and pragmatic problem-solverExperience with data security / ISO 27001 is a plusFluent in English; Dutch not requiredOn-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 carePlay a pivotal role in shaping the QA/QMS function from the inside outJoin a diverse and informal team with short lines, speed, and ambitionSalary based on experience, plus additional benefits including stock appreciation rights25 holidays (with option to buy more), good pension scheme, and training opportunitiesInterested?Let’s connect. Unity Partners is exclusively supporting this confidential search.📧 christian@unitypartners.nl📞 +31 (0)20 8938 606