ISO 13485 Lead Auditor - Contractor and Full-time Opportunities
RemoteUnited States
Job Summary
Conduct audits to evaluate medical device quality management systems for conformity with ISO 13485 and applicable regulatory requirements. Prepare audit plans, review client documentation, and assess readiness for certification activities by performing assessments of client facilities, processes, and quality management systems. Identify and document nonconformities, observations, and opportunities for improvement while maintaining complete and accurate audit records in accordance with accreditation requirements. Submit expense reports and other critical audit documentation within established timelines and maintain acquired auditor credentials. This role supports Smithers' commitment to delivering accurate, timely, and high-touch certification services to medical device manufacturers through global, accredited third-party assessment activities.
Required Qualifications
- Experience in the entire process of auditing medical device quality management systems, including review of documentation and risk management of applicable medical devices, parts or services, implementation audit, and audit reporting
- Experience participating as a trainee in a minimum of four audits totaling at least 20 days in an accredited QMS program, 50% of which shall be against ISO 13485, preferably in an accredited program, and the rest in any other accredited QMS program
- Successfully completed the Audit Team Leader role, under the supervision of a qualified Lead Auditor, for at least three ISO 13485 third-party certification audits
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.