Lead Auditor

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