Job SummaryTUV Rheinland UK is looking for a Lead Auditor, responsible for planning and conducting medical device audits in compliance with EU and UK Regulations/Legislation. Job DescriptionPlans, prepares and carries out audits in compliance with EU MDR, EU IVDR, UK MDR, MDSAP, and ISO 13485. Coordinates the schedule and audit plan with the customer and, if necessary, with the auditor team Collects and analyses data to detect deficient controls, duplicated effort, fraud or noncompliance with laws, regulations, and management policies. Might lead the audit in the function of the lead auditor. Records strengths, deviations, recommendations and evidence viewed. Creates audit documentation and audit reports. Prepares explains audit findings and recommends solutions to auditee. And other duties as assigned.Essential Requirements:2 years’ experience as medical device auditor2 years’ experience in Design, Manufacturing, or Testing of Medical DevicesIdeally registered IRCA auditor or equivalent recognition with a recognised bodyKnowledge of UK MDR 2002Knowledge of ISO 13485Knowledge of EU MDD 93/42/EC, EU MDR 2017/745Significant UK travel with limited international travelFull UK Driving Licence