Job Summary
TUV 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 Description
* Plans, 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 auditor
* 2 years’ experience in Design, Manufacturing, or Testing of Medical Devices
* Ideally registered IRCA auditor or equivalent recognition with a recognised body
* Knowledge of UK MDR 2002
* Knowledge of ISO 13485
* Knowledge of EU MDD 93/42/EC, EU MDR 2017/745
* Significant UK travel with limited international travel
* Full UK Driving Licence