75K–90K GBP / year
Medical Device Auditor
QAOn-site — London, UK
Published on 2026-09-09
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About this role
Audit medical device manufacturers’ quality management systems and produce clear findings to support certification decisions. The role combines reviewing evidence with interviewing teams, and includes training in the company’s audit methods and tools. Travel is limited, though occasional trips may be required.
About the company
Scarlet is a notified body that certifies AI and software medical devices under EU MDR and UK MDR without unnecessary delays.
The team
Devices
What you'll do
- Plan and conduct QMS audits against ISO 13485, EU MDR, and UK MDR requirements.
- Review records and interview teams to assess compliance.
- Document evidence, findings, and conclusions in audit reports.
- Explain findings constructively and keep customers informed.
- Review corrective actions and evidence for closing findings.
What we're looking for
- Degree in a relevant scientific, engineering, or medical discipline.
- At least four years of medical device industry experience, including two years auditing or managing an ISO 13485 QMS.
- Working knowledge of EU MDR or UK MDR quality management requirements.
- Ability to explain audit findings or regulatory requirements clearly in writing and conversation.
- Software experience demonstrating knowledge of design, validation, testing, debugging, and operating-environment interactions.
Nice to have
- Experience conducting audits for a certification or notified body.
- Experience with medical device software.
Benefits
- Equity
Hiring process
- 30-minute introductory call.
- 40-minute QMS audit exercise and discussion.
- Two 20-minute founder interviews.
- Offer and references.