Cure Talent
Medical Device Auditor
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Cure Talent are delighted to be partnered with a growing medical device certification organisation that is expanding its UK audit team. With continued growth in demand, the business is now looking to appoint a Medical Device Auditor to support manufacturers across a range of medical device technologies.
This is an opportunity for an experienced industry-side Quality professional to move into external auditing. Prior experience working for a Notified Body is not essential. The business is particularly interested in candidates who understand what it is like to build, maintain and operate a compliant Quality Management System from within a medical device company and can bring that practical perspective into the audit environment.
The role will involve conducting evidence-led ISO 13485 audits, working directly with manufacturers to understand their systems, assess conformity and communicate findings clearly and objectively. The approach is collaborative rather than adversarial, with a strong emphasis on technical credibility, professional judgement and delivering a positive client experience without compromising regulatory standards.
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Key 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.
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The Ideal Candidate Will Have
- 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.
This is a fully remote UK-based position with travel required as part of the role.
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