Quality & Regulatory Compliance

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- 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 general 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

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- 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

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- Ensure robust risk management practices across:
- Manufacturing processes
- Material changes
- Supplier changes
- Lead investigations for quality events, deviations, and escapes.
- Ensure CAPAs are data-driven, systemic, and aligned with regulatory expectations.

Supplier & External Compliance

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- Oversee supplier qualification, audits, and ongoing monitoring.




- Ensure compliance related to:
- Outsourced processes
- Critical suppliers
- Cybersecurity considerations impacting QMS (as applicable)

Manufacturing & Operations Interface

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- Partner closely with:
- Manufacturing Engineering
- Quality
- Supply Chain
- Operations
- Ensure compliance is embedded in day-to-day operations (IQC, MRB, change control, product release).
- Support NPI, transfers, and special builds from a compliance and risk standpoint.

Export & Medical Device Shipping Compliance

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- Ensure regulatory compliance for export of medical devices to the U.S. and other markets.
- Verify documentation integrity for product release and shipment.
- Support regulatory requirements related to combination products if applicable.

Training & Culture

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- Develop and deploy compliance and regulatory training across the organization.
- Build a strong quality culture focused on prevention, discipline, and accountability.

📌 QMS Engineer (Tijuana)
🏢 Grupo TECMA
📍 Tijuana