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Compliance Officer – Medical Devices (EMS)

Company

Grupo TECMA

Location

tijuana, tijuana

Posted

June 27, 2026

Position Overview

            Quality & Regulatory Compliance  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. 
 Audits & Inspections  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. 
 Risk Management & CAPA  Ensure robust risk management practices across: 
Manufacturing processes 
Material changes 
Supplier changes 
Lead invest...
        

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Compliance Officer – Medical Devices (EMS)

Position Overview

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