Technical Reviewer – ISO 13485

Job Summary:

This role ensures technical accuracy and consistency in audit documentation. The reviewer works closely with auditors to verify findings, confirm conformance to standards, and maintain audit integrity.

Key Responsibilities:

  • Review completed audit reports for ISO 13485.
  • Validate technical content and ensure regulatory compliance.
  • Provide recommendations to improve report clarity and precision.
  • Collaborate with lead auditors and quality teams.

Requirements:

  • Expertise in ISO 13485 and medical device quality systems.
  • 3+ years in auditing or quality review.
  • Strong attention to detail and technical writing skills.

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