Quality Assurance Specialist
Quality Assurance Specialist - Class IIb Medical Device
Location: Eindhoven, Netherlands
Start Date: May 2026
Contract Length: 12 months (freelance)
About the Opportunity
A leading medical device organisation in the Randstad region is seeking an experienced Quality Assurance Specialist to support end‑to‑end risk management activities for a Class IIb medical device portfolio. The assignment includes backlog remediation, ongoing maintenance of risk files, MDR‑related updates, and continuous improvement work aligned with ISO 14971 and EU MDR requirements.
Key Responsibilities
- Update and maintain risk management files, including backlog items and historical CAPA‑related RMFs.
- Perform routine RMF updates driven by non‑compliance events, PMS data, HHE, and new product information.
- Provide risk management support to cross‑functional projects (e.g., CRO, MORP, new product development).
- Conduct internal training sessions on risk management principles and requirements.
- Prepare and update RMFs for MDR submissions in alignment with EU MDR and ISO 14971.
- Respond to notified body questions related to risk documentation.
- Support continuous improvement activities, including transferring risk data into databases and updating documentation within the eQMS.
Required Experience
- 5+ years in Risk Management within the medical device industry.
- Strong expertise in ISO 14971, EU MDR, and QMS frameworks.
- Experience with Class IIb devices (or higher preferred).
- Demonstrated ability to manage complex RMF updates across multiple stakeholders.
- Ability to operate autonomously as a contractor in a fast‑paced regulatory environment.
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