Senior QMS & Regulatory Compliance Lead

Grupo TECMA; Tijuana; Presencial; MXN 600.000 - 900.000; Jornada completa

Descripción de la vacante

Grupo TECMA is seeking a senior Quality & Regulatory Compliance leader to own the site QMS and ensure alignment with FDA QMSR and ISO 13485 in Tijuana. You will lead audits (FDA, ISO, customer) and drive CAPA, risk management, and change control while coordinating with Manufacturing, Quality, and Supply Chain to embed compliance into daily operations and export processes.

Fluent English is required for audits and executive communication, and the role demands strong collaboration with

Formación

• 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.

Responsabilidades

• Own and maintain the site Quality Management System (QMS) in alignment with FDA QMSR (21 CFR 820) and ISO 13485:2016.
• Lead and host FDA inspections, ISO / registrar audits, and customer audits; manage audit responses and closure.
• Develop and track CAPAs to ensure root cause effectiveness and prevention of recurrence.
• Ensure QMS documentation is current, effective, and audit-ready.
• Oversee supplier qualification, audits, and ongoing monitoring; ensure compliance for outsourced processes.
• Partner with Manufacturing, Quality, Supply Chain, and Operations to embed compliance in day-to-day operations.
• Support NPI, transfers, and special builds from a compliance and risk standpoint.
• Ensure regulatory export compliance for medical devices to the U.S. and other markets; verify release documentation.

Conocimientos

Fluent English

Regulatory knowledge

Auditing experience

CAPA

Risk management

FDA QMSR

ISO 13485

Educación

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

Descripción del empleo

Grupo TECMA is seeking a senior Quality & Regulatory Compliance leader to own the site QMS and ensure alignment with FDA QMSR and ISO 13485 in Tijuana. You will lead audits (FDA, ISO, customer) and drive CAPA, risk management, and change control while coordinating with Manufacturing, Quality, and Supply Chain to embed compliance into daily operations and export processes.

Fluent English is required for audits and executive communication, and the role demands strong collaboration with