🏥 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.