Senior Medical Device Compliance Officer - QMS & Audits

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

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.