Medical Device QMS Auditor (ISO 13485 & MDR)

Scarlet; Greater London; Hybrid; GBP 65,000 - 95,000; Full time

Job summary

Scarlet seeks a Medical Device Auditor based in London or Sweden to audit manufacturers’ quality management systems in line with ISO 13485, EU MDR and UK MDR. You will gain training in Scarlet’s audit methods and work with product teams to ensure evidence-based certification decisions.

The role involves reviewing records, interviewing staff, documenting findings and producing clear audit reports. Occasional travel may be required to ensure safe, compliant devices reach patients.

Qualifications

• Bachelor's or higher degree in a relevant scientific, engineering, or medical field.
• At least four years in the medical device industry, including two years auditing or ISO 13485 QMS management.
• Working knowledge of EU MDR or UK MDR requirements for QMS.
• Ability to explain audit findings clearly in writing and conversation.

Responsibilities

• Plan and conduct QMS audits against ISO 13485, EU MDR and UK MDR.
• Review records and interview teams to verify processes meet requirements.
• Document evidence, findings, and conclusions in audit reports.
• Explain findings constructively and keep customers informed.
• Review corrective actions and close findings with evidence.

Skills

QMS auditing

Regulatory knowledge

Technical writing

Stakeholder communication

Education

Degree in a relevant scientific, engineering or medical discipline

Tools

Software design knowledge

Software validation

Software testing

Software debugging

Job description

Scarlet seeks a Medical Device Auditor based in London or Sweden to audit manufacturers’ quality management systems in line with ISO 13485, EU MDR and UK MDR. You will gain training in Scarlet’s audit methods and work with product teams to ensure evidence-based certification decisions.

The role involves reviewing records, interviewing staff, documenting findings and producing clear audit reports. Occasional travel may be required to ensure safe, compliant devices reach patients.