The Lead Auditor will conduct third-party audits for medical device clients to ensure compliance with ISO standards, MDSAP, and CE Marking requirements. Responsibilities include managing a client portfolio, planning assessments, conducting site visits, and completing detailed audit reports.
You will conduct independent or team-based evaluations of technical documentation and design dossiers to verify medical device conformity with CE marking requirements. Additionally, you will coordinate with clinical and technical experts to produce comprehensive review reports that determine the safety and effectiveness of medical devices.
