Senior Quality Assurance Engineer

Unity Partners on behalf of our MedTech partnerOur partner is a fast-growing MedTech company developing cutting-edge robotic solutions that bring innovation, safety, and precision. With their technology, they make healthcare more reliable and accessible.As part of the growing Quality & Regulatory team, we’re looking for a Senior Quality Engineer to strengthen the company’s QMS and ensure compliance across the full product lifecycle — from design to post-market.Key ResponsibilitiesAs a Senior Quality Engineer, you will:Maintain and improve the ISO 13485-compliant QMS, ensuring processes are effective, efficient, and future-proof.Support design control and risk management activities during development and verification.Contribute to technical documentation and ensure compliance with MDR and other applicable regulations.Coordinate and perform internal audits and manage supplier qualification and performance monitoring.Drive CAPA, change control, and non-conformance management processes.Collaborate with R&D, Operations, and Clinical teams to translate quality standards into practical processes.Provide quality support during production, validation, and testing, ensuring continuous improvement.Prepare for and support notified body audits and regulatory inspections.Your ProfileBachelor’s or Master’s degree in Biomedical, Mechanical, or Industrial Engineering, or related discipline.10+ years of experience in Quality Assurance or Quality Engineering within the medical device industry.Solid understanding of ISO 13485, ISO 14971, and the EU MDR (2017/745).Experience with electromechanical or robotic medical devices is a strong advantage.Analytical, structured, and able to operate both hands-on and strategically.Strong communication and stakeholder management skills; able to work cross-functionally.Fluent in English (Dutch is a plus).Organization & OfferYou’ll join a pioneering MedTech scale-up combining robotics and medical device innovation to improve patient experience. The team is multidisciplinary, collaborative, and driven by a shared purpose. What you can expect:A role with ownership and visibility in shaping quality systems and processes.A dynamic and open culture where your ideas directly impact product and process quality.Competitive compensation and benefits package.Hybrid working possibilities from their modern facility in the Utrecht region.Interested?Reach out to Christian Steenkamp at christian@unitypartners.nl or connect via LinkedIn.