Full-time Posted June 19, 2026
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Job Description

The Opportunity

This role ensures that all medical devices are released in full compliance with applicable regulatory requirements (ISO 13485, 21 CFR Part 820, NOM-241), internal procedures, and customer specifications. The individual oversees the documentation review process, manages the Quality Release team, drives continuous improvement initiatives, and serves as the primary decision-maker for nonconformities related to final product documentation.

 What You’ll Do

  • Lead and develop the Quality Release team, ensuring workload coordination, performance oversight, and procedural compliance.
  • Review and approve DHRs, batch records, CoCs, and related documentation in accordance with GDP and regulatory standards.
  • Ensure accurate product status updates in quality/ERP systems and escalate documentation or product discrepancies.
  • Support regulatory compliance efforts, including audits and change controls related to product relea...
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