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 and explains audit findings and recommends solutions to auditee.
Other duties as assigned.
Minimum Requirements
2 years’ experience as a 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.
#J-18808-Ljbffr
2 years’ experience as a 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.
#J-18808-Ljbffr
