Job Description

y detalle de las actividades

This role ensures full compliance with FDA regulations (QMSR / 21 CFR 820), ISO 13485, and applicable international regulatory requirements, while acting as the primary interface with auditors, customers, and regulatory bodies. The ideal candidate brings deep hands-on experience in regulated EMS environments and is comfortable operating at both strategic and tactical levels.

Quality & Regulatory Compliance

  • Own and maintain the site Quality Management System (QMS) in alignment with:

o FDA QMSR (21 CFR 820 – ISO 13485:2016 aligned)

o ISO 13485 and applicable global regulations

  • Monitor and implement regulatory updates (FDA, ISO, international) and translate them into actionable site requirements.
  • Ensure QMS documentation is current, effective, and audit-ready.

Audits & Inspections

  • Lead and host:

o FDA inspections

o ISO / registrar audits

o Custo...

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