Quality Engineer, Production

Exclusively on behalf of our partner AMT Medical, Unity Partners is looking for a Quality Engineer Production.AMT Medical is a pioneering medical device company developing a transformative heart bypass procedure. With its groundbreaking Elana Anastomotic System, AMT aims to revolutionize Coronary Artery Bypass Surgery (CABG). This minimally invasive technology enables surgeons to create a sutureless bypass on a beating heart—without a heart-lung machine—reducing patient impact and accelerating recovery.As Quality Engineer – Production, you will take ownership of quality assurance across our manufacturing activities for Class III cardiovascular devices. You will play a key role in ensuring compliant, efficient, and high-quality production processes in a cleanroom environment. From validation to supplier quality, inspection, and continuous improvement, this is a hands-on position with strategic influence.Key ResponsibilitiesLead process validation (IQ/OQ/PQ) for both new and existing production processes.Oversee quality control and inspection activities, develop sampling plans, and resolve complex QC challenges.Manage and improve the supplier quality system, including audits, SCARs, and qualification of new suppliers.Drive CAPA and nonconformance investigations, using structured root cause analysis (Lean/Six Sigma).Ensure full compliance with FDA 21 CFR 820, ISO 13485, and MDR requirements.Collaborate with production, engineering, and procurement teams to embed a strong quality culture.Mentor operators and staff in regulatory expectations, procedures, and quality best practices.What You BringA Bachelor’s degree in Engineering or a related technical/scientific discipline (Master’s a plus).5+ years of experience in QA within the medical device industry, preferably with Class III devices.Deep experience with manufacturing process validation and working in cleanroom environments.Strong expertise in supplier quality management, quality control, and statistical techniques.In-depth knowledge of relevant regulations: ISO 13485, FDA QSR, MDR, and ISO 14971.Strong communication skills and a hands-on mindset with a drive for results.Comfortable working in a fast-paced, scaling environment with high impact.Organization & OfferYou’ll join a fast-growing scale-up at the cutting edge of cardiac care innovation. With clinical trials already underway and growing international traction, your role will have immediate and visible impact. Expect a collaborative work culture, competitive salary & benefits, and strong support for professional development and leadership growth.INTERESTED?Reach out to Christian Steenkamp via christian@unitypartners.nl or +31 (0)20 8938 606 for more information or apply directly