Medical Device Auditor

Barrington James; Greater London; On-site; GBP 55,000 - 75,000; Full time

Job summary

Barrington James is seeking a Medical Device Auditor to assess manufacturers’ QMS against ISO 13485, EU MDR and UK MDR standards. The role involves auditing, interviewing teams, and producing well-evidenced reports. Training is provided, with limited travel to customer sites.

Ideal candidates hold a degree in a relevant field and have at least four years in the medical device sector, including two+ years in auditing or ISO 13485 QMS management, plus knowledge of EU/UK MDR requirements.

Qualifications

• 4+ years in medical device industry, with auditing or ISO 13485 QMS management experience.
• Ability to explain audit findings clearly in writing and speaking.
• Knowledge of EU MDR or UK MDR requirements for quality management systems.

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

Skills

Auditing

QMS knowledge

Regulatory knowledge

Audit reporting

Education

Degree in science/engineering/medical

Job description

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