Freelance Quality Engineer – Medical Devices
6-Month Contract
International Medical Device Markets (Europe, Middle East & Asia)
A growing medical device company based in Belgium is seeking an experienced Freelance Quality Engineer to support ongoing quality and compliance activities across international markets.
This is an excellent opportunity for a hands‑on quality professional with medical device industry experience and strong exposure to global regulatory and quality systems.
Key Responsibilities
* Manage and support CAPA activities from initiation through closure
* Handle Non-Conformance Reports (NCRs) and root cause investigations
* Support and lead change control processes
* Conduct and support customer complaint/investigation activities
* Participate in internal and external audits
* Perform duties as a Lead Auditor
* Ensure compliance with applicable medical device quality standards and regulatory requirements
* Collaborate cross‑functionally with QA/RA, Operations, Manufacturing, and Engineering teams
* Support continuous improvement initiatives within the Quality Management System (QMS)
Requirements
* 3+ years of hands‑on experience within the medical device industry
* Strong working knowledge of:
o CAPA
o NCR management
o Change controls
o Auditing activities
o Experience acting as a Lead Auditor
* Familiarity with international medical device markets including:
o Europe
o Middle East
o Asia
* Experience supporting or working with the Chinese medical device market is highly desirable
* Strong understanding of medical device quality standards and regulated environments
* Excellent communication and stakeholder management skills
* Freelance / Contractor position
* 6‑month initial contract
* 40 hours per week
Nice to Have
* Experience with global post‑market surveillance activities
* Exposure to international regulatory submissions or compliance support
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