Compliance Officer – Medical Devices (EMS)

• Own and maintain the site Quality Management System (QMS) in alignment with:
• FDA QMSR (21 CFR 820 – ISO 13485:2016 aligned)
• 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.

• Lead and host:
• FDA inspections
• ISO / registrar audits
• Customer audits (medical device OEMs)
• Own audit preparation, execution, response, and closure.
• Develop and track CAPAs to ensure root cause effectiveness and prevention of recurrence.

• Ensure robust risk management practices across:
• Manufacturing processes
• Material changes
• Supplier changes
• Lead invest...

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