Medical Device Auditor

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 ResponsibilitiesConduct 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 ..... full job details .....