Remote ISO 13485 Medical Device Auditor

Cure Talent Ltd; Greater London; Remote; GBP 55,000 - 90,000; Full time

Job summary

Cure Talent Ltd. is partnering with a growing medical device certification organisation that is expanding its UK audit team. The Medical Device Auditor will support manufacturers across diverse medical device technologies, conducting evidence-led ISO 13485 audits and delivering clear reports.

The ideal candidate has strong QA experience in medical devices and a practical understanding of QMS, with ability to work remotely within the UK and travel as required to client sites.

Qualifications

• Strong Quality Assurance experience within the medical device industry.
• Extensive practical knowledge of ISO 13485 and Medical Device Quality Management Systems.
• Experience conducting internal, supplier or external audits within a regulated medical device environment.
• A relevant degree in science, engineering or another applicable technical discipline.
• Experience working directly with cross-functional teams including Quality, Regulatory, Engineering and senior stakeholders.
• Strong communication skills, with the confidence to challenge appropriately while maintaining a professional and collaborative approach.
• The ability to assess evidence objectively and make clear, defensible Quality decisions.
• Experience within SaMD, software medical devices or IEC 62304 would be highly advantageous.

Responsibilities

• Conduct Quality Management System audits against ISO 13485 and applicable medical device regulatory requirements.
• Plan and lead audit activity, reviewing documentation, interviewing relevant stakeholders and following evidence trails to assess conformity.
• Produce clear, technically robust audit reports and communicate findings effectively with manufacturers.
• Assess nonconformities objectively, ensuring conclusions are supported by appropriate evidence.
• Work closely with manufacturers across Quality, Regulatory, Engineering and senior leadership functions throughout the audit process.
• Manage audit activity independently, including preparation, delivery, reporting and follow-up within agreed timelines.
• Maintain current knowledge of applicable medical device standards, regulations and industry developments.
• Complete the organisation's internal training and qualification programme to achieve the required auditor authorisations.
• Travel to client sites as required across the UK and potentially internationally.

Skills

QA experience

ISO 13485

Audit experience

Cross-functional teamwork

Effective communication

Evidence-based decisions

Education

Science/Engineering degree

Job description

Cure Talent Ltd. is partnering with a growing medical device certification organisation that is expanding its UK audit team. The Medical Device Auditor will support manufacturers across diverse medical device technologies, conducting evidence-led ISO 13485 audits and delivering clear reports.

The ideal candidate has strong QA experience in medical devices and a practical understanding of QMS, with ability to work remotely within the UK and travel as required to client sites.