Lead Auditor – ISO 13485

Job Summary:

The ISO 13485 Lead Auditor is tasked with auditing medical device manufacturers and related organizations to ensure compliance with regulatory and quality management system requirements under ISO 13485.

Key Responsibilities:

  • Conduct third-party audits for ISO 13485 certification.
  • Evaluate compliance with quality standards and regulatory frameworks.
  • Document findings, prepare audit reports, and suggest improvements
  • Assist in training and mentoring junior auditors.

Requirements:

  • ISO 13485 Lead Auditor Certification.
  • Background in biomedical, life sciences, or quality assurance.
  • Experience in the medical device industry.
  • Knowledge of FDA/MDR guidelines is a plus.

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