Our client is a fast-growing, well-funded company authorised to assess and certify medical devices, combining clinical, technical and regulatory expertise with modern technology to help ambitious health-tech companies bring safe products to market faster, without lowering the safety bar. They’ve seen strong growth over the past year and are expanding their customer base and international footprint.
About the role
As a Medical Device Auditor, you’ll audit medical device manufacturers’ quality management systems and produce clear, well-evidenced conclusions that support certification decisions. Full training in our client’s audit methods and tools is provided, this is an excellent next step for someone currently working in-house in quality who’s ready to move to the assessor’s side of the table. Travel is limited, with occasional trips to customer sites.
Responsibilities
- Plan and conduct QMS audits against ISO 13485, EU MDR and UK MDR requirements
- Review records and interview teams to assess whether processes meet requirements
- Document evidence, findings and conclusions in clear, timely audit reports
- Explain findings constructively and keep customers informed throughout the audit
- Review corrective actions and the evidence needed to close findings
What we’re looking for
- A degree in a relevant scientific, engineering or medical discipline
- At least 4 years’ experience in the medical device industry, including 2+ years auditing or managing an ISO 13485 QMS
- Working knowledge of EU MDR or UK MDR requirements for quality management systems
- Experience explaining audit findings or regulatory requirements clearly, in writing and conversation
- Some knowledge of software design, validation, testing and debugging, many of the products you’ll assess are software-driven medical devices
Nice to have
- Experience conducting audits for a certification or notified body
#J-18808-Ljbffr…