Compliance Officer – Medical Devices (EMS)

Grupo TECMA; Tijuana; Presencial; MXN 900.000 - 1.300.000; Jornada completa

Descripción de la vacante

Grupo TECMA in Mexico seeks a seasoned Quality & Regulatory Compliance professional to own and maintain the QMS, lead FDA and ISO audits, and drive CAPA and risk management programs. You will collaborate across Manufacturing Engineering, Quality, Supply Chain, and Operations to embed compliance in daily operations.

The role requires deep regulatory knowledge (FDA QMSR, ISO 13485) and fluent English for audits and executive communication.

Formación

• Bachelor’s degree in Engineering, Quality, Regulatory Affairs, or related field.
• 7+ years of experience in medical device manufacturing or EMS with regulatory exposure.
• Deep knowledge of FDA 21 CFR 820 / QMSR.
• ISO 13485:2016 experience.
• Proven experience leading FDA and customer audits.
• Strong background in CAPA, risk management, and change control.
• Experience working with international customers and corporate stakeholders.
• Fluent English (written and spoken).

Responsabilidades

• Own and maintain the site Quality Management System (QMS) in alignment with FDA QMSR (21 CFR 820) and ISO 13485:2016.
• Monitor and implement regulatory updates and translate them into actionable site requirements.
• Ensure QMS documentation is current, effective, and audit-ready.
• Lead and host FDA inspections and ISO registrar audits.
• Own audit preparation, execution, response, and closure.
• Develop and track CAPAs to ensure root cause effectiveness and prevention of recurrence.
• Oversee supplier qualification, audits, and ongoing monitoring.
• Ensure regulatory compliance for export of medical devices to the U.S. and other markets.
• Partner with Manufacturing Engineering, Quality, Supply Chain, Operations.
• Support NPI, transfers, and special builds from a compliance and risk standpoint.
• Provide cybersecurity considerations within QMS as applicable.
• Develop and deploy compliance training; build a quality culture focused on prevention and accountability.
• Act as a mentor and subject-matter expert for Quality and Engineering teams.

Conocimientos

Quality management systems

Regulatory compliance

Audits & inspections

CAPA & risk management

Cross-functional collaboration

Fluent English

7+ years experience

Educación

Bachelor’s degree in Engineering, Quality, Regulatory Affairs, or related field

Descripción del empleo

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 investigations for quality events, deviations, and escapes.


• Ensure CAPAs are data-driven, systemic, and aligned with regulatory expectations.

Supplier & External Compliance

• Oversee supplier qualification, audits, and ongoing monitoring.


• Ensure compliance related to:


• Outsourced processes


• Critical suppliers


• Cybersecurity considerations impacting QMS (as applicable)

Manufacturing & Operations Interface

• 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

• 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

• Develop and deploy compliance and regulatory training across the organization.


• Build a strong quality culture focused on prevention, discipline, and accountability.

Act as a mentor and subject-matter expert for Quality and Engineering teams

Required Qualifications

• Bachelor’s degree in Engineering, Quality, Regulatory Affairs, or related field.


• 7+ years of experience in medical device manufacturing or EMS with strong regulatory exposure.


• Deep, hands-on knowledge of:


• FDA 21 CFR 820 / QMSR


• ISO 13485:2016


• Proven experience leading FDA and customer audits.


• Strong background in CAPA, risk management, and change control.


• Experience working with international customers and corporate stakeholders.


• Fluent English (written and spoken) – required for audits and executive communication.

Preferred Qualifications

• Experience in EMS or high-mix / low-volume medical manufacturing.


• Prior interaction with FDA investigators.


• Experience supporting FDA registrations and site readiness.


• Familiarity with MDSAP (preferred, not required).


• Strong understanding of cybersecurity considerations within QMS.


• Certification in Quality or Regulatory disciplines (ASQ, RAPS, etc.).