ISO 13485 Lead Auditor - Contractor and Full-time Opportunities

Smithers Careers•Fairlawn, OH

About The Position

The Quality Assessments Division of Smithers is seeking experienced ISO 13485 Third-Party Auditors to perform assessment and certification activities for medical device manufacturers and related organizations against ISO 13485 requirements and applicable regulatory standards. Your goal is to build positive relationships with our clients while providing quality auditing and exceptional client services while maintaining a high level of integrity and impartiality. We are hiring for both full-time and contract opportunities. The Quality Assessments Division of Smithers (SQA) is a global, accredited third-party Certification Body. As a member of our audit team, you will play a critical role in helping clients demonstrate compliance while supporting Smithers' commitment to delivering accurate, timely, and high-touch certification services. If you are passionate about quality, regulatory excellence, and making a meaningful impact in the medical device industry, we encourage you to join our team.

Requirements

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.

Responsibilities

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.
Perform assessments of client facilities, processes, and quality management systems to determine compliance with certification requirements.
Evaluate documented information, operational processes, and quality system implementation to verify the effectiveness of the management system.
Identify and document nonconformities, observations, and opportunities for improvement.
Maintain complete and accurate audit records in accordance with accreditation requirements and internal procedures.
Submit expense reports and other critical audit documentation within established timelines.
Maintain acquired auditor credentials.