ISO 13485 Lead Auditor

This is a fully remote position, open to applicants in Ohio.

📋 Description

• Conduct audits to assess the quality management systems of medical devices for compliance with ISO 13485 and relevant regulatory standards.

• Develop audit plans, review client documentation, and evaluate readiness for certification processes.

• Perform evaluations of client facilities, processes, and quality management systems to ensure adherence to certification standards.

• Analyze documented information, operational processes, and the execution of quality systems to confirm the effectiveness of the management system.

• Identify and record nonconformities, observations, and areas for enhancement.

• Keep thorough and precise audit records in line with accreditation standards and internal policies.

• Submit expense reports and essential audit documentation within set deadlines.

• Sustain acquired auditor certifications.

• Foster positive relationships with clients while delivering high-quality auditing and outstanding client services.

• Assist in providing accurate, timely, and personalized certification services for medical device manufacturers and related entities.

⛳️ Requirements

• Experience in auditing medical device quality management systems, including documentation review, risk management, implementation audits, and audit reporting.

• Participation as a trainee in a minimum of four audits totaling at least 20 days in an accredited QMS program.

• At least 50% of trainee auditing experience must be focused on ISO 13485.

• The remainder of trainee auditing experience may be within another accredited QMS program.

• Audit team leaders must have fulfilled the Audit Team Leader role under a qualified Lead Auditor for no less than three ISO 13485 third-party certification audits.

• Maintain acquired auditor certifications.

• Uphold a high standard of integrity and impartiality.

• For full-time positions: variable salary based on experience and work efficiency.

🏝️ Benefits

• Medical, dental, and vision benefit plans.

• 401(k) retirement savings plan.

• Life insurance and accidental death & dismemberment (AD&D) coverage.

• Short-term and long-term disability insurance.

• Wellness Program.

• Employee Assistance Program (EAP).

• Business Operation System (BOS) – SQA Audit Management Platform.

• Support for training and development.

• Flexible work schedule.

• Priority in assignments.