Quality Assurance Engineer

Unity Partners exclusively on behalf of our MedTech partnerOur partner is an established player in the medical device industry, developing innovative treatment solutions used by healthcare providers worldwide. With a dedicated focus on a specific product line within their broader portfolio, quality and regulatory compliance sit at the core of how they operate.To strengthen their Quality team on a structural basis, we are looking for an experienced QA Engineer who can quickly operate independently and make a direct impact from day one.Role OverviewAs QA Engineer, you join a close-knit QA team, working closely alongside the RA team. These teams collaborate cross-functionally with Engineering, Sales & Marketing, Supply Chain and Manufacturing to keep products and processes aligned with current standards and regulations across the medical device industry. This is a permanent position.Key ResponsibilitiesEnsure product compliance for an assigned value stream within the product portfolioSupport the local and global QMS and related processesRepresent the QA organisation in processes such as non-conformances, CAPA, and complaint handling, or provide technical input to functions like Order Fulfilment and ManufacturingEnsure accurate reporting and documentation across quality assurance processesContinuous optimisationParticipate in auditsYour ProfileBachelor's degree in Engineering or a related fieldSeveral years of relevant experience as a QA Engineer within the medical device industry, with the ability to operate independentlyStrong working knowledge of ISO 13485 and experience in regulated quality environmentsExperience with comparable devices, such as Class IIa or IIb medical devicesHands-on audit experienceFDA experience is a plus, though not requiredStrong written and verbal communication skillsAn open, approachable personality who fits naturally within a relaxed, informal team cultureComfortable working efficiently under tight timelines with minimal supervisionWhy join?Be part of a global organisation making a tangible difference in healthcareStep into a close, collaborative Quality and Regulatory team with real ownership from the startA permanent role with long-term impact, not a temporary assignmentInterested? Reach out to Christian Steenkamp via christian@unitypartners.nl | +31 (0)20 8938 606