🏥 Senior Quality Engineer (Freelance) – Medical Devices📍 Hoogstraten region, Antwerp, Belgium | ⏳ 6–12 months | 💼 FreelanceWe 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 ResponsibilitiesSupport the implementation and rollout of a digital QMSManage and maintain quality documentation (procedures, WI, training)Contribute to CAPA, change control, and document control processesHandle supplier complaints (SCAR)Support risk management activities (ISO 14971)Assist with post-market surveillancePrepare and support internal & external auditsEnsure overall compliance with regulatory standards (ISO 13485 / MDR)🎯 Your ProfileMaster’s degree in Engineering, Life Sciences, or similar5+ years’ experience in Quality within Life Sciences / Medical DevicesStrong knowledge of ISO 13485 (mandatory)Experience with MDR 2017/745 (essential)Knowledge of ISO 14971 (risk management) is a plusHands-on experience with QMS systems, CAPA & change managementStructured, proactive, and solution-oriented mindsetStrong stakeholder communication skills🌍 LanguagesDutch (mandatory)English (mandatory)💡 What’s on Offer6–12 month freelance projectOpportunity to play a key role in a QMS digital transformationWork in a high-impact medical device environmentCollaborative 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.