Senior Quality Engineer (Freelance) – Medical Devices Hoogstraten region, Antwerp, Belgium | ⏳ 6–12 months | Freelance We are currently supporting an innovative medical device manufacturer in the Hoogstraten region, specialising in products used in cardiac surgery. Operating in a highly regulated environment, the company combines cleanroom manufacturing, R&D, and quality excellence within a collaborative and flat organisational structure. They are now looking for a Senior Quality Engineer to support the digitalisation and optimisation of their Quality Management System (QMS). Your Responsibilities Support the implementation and rollout of a digital QMS Manage and maintain quality documentation (procedures, WI, training) Contribute to CAPA, change control, and document control processes Handle supplier complaints (SCAR) Support risk management activities (ISO 14971) Assist with post-market surveillance Prepare and support internal & external audits Ensure overall compliance with regulatory standards (ISO 13485 / MDR) Your Profile Master’s degree in Engineering, Life Sciences, or similar 5+ years’ experience in Quality within Life Sciences / Medical Devices Strong knowledge of ISO 13485 (mandatory) Experience with MDR 2017/745 (essential) Knowledge of ISO 14971 (risk management) is a plus Hands-on experience with QMS systems, CAPA & change management Structured, proactive, and solution-oriented mindset Strong stakeholder communication skills Languages Dutch (mandatory) English (mandatory) What’s on Offer 6–12 month freelance project Opportunity to play a key role in a QMS digital transformation Work in a high-impact medical device environment Collaborative team across Quality, R&D, and Production Interested? If you are a senior QA professional with strong medical device experience looking for your next freelance challenge, feel free to reach out directly.