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.
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.
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
