Medical Device Auditor

The role

You will audit medical device manufacturers' quality management systems and produce conclusions to support certification decisions. The role involves reviewing evidence and interviewing teams to assess processes.

What you will do

• 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

Required qualifications

• A degree in a relevant scientific, engineering or medical discipline
• At least four years' experience in the medical device industry
• Two 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 in conversation
• Experience with software demonstrating knowledge of software design, validation, testing, debugging and interactions with its operating environment

Nice to have

• Experience conducting audits for a certification or notified body
• Experience with medical device software

Before you apply

• Introductory call with Sandy
• QMS audit exercise and discussion with Felicia
• Founder interviews with James and Jamie
• Offer and references

About the company

Scarlet is authorised to assess and certify medical devices. They combine clinical, technical and regulatory expertise with AI agents and software.