FDA Quality Systems Engineer (AR)

Grupo TECMA; Tijuana; Presencial; MXN 1,288,000 - 1,633,000; Jornada completa

Descripción de la vacante

A leading medical device manufacturing firm in Tijuana seeks a Quality & Regulatory Compliance professional to ensure full compliance with FDA regulations and ISO standards. The role requires a minimum of 7 years of experience in medical device manufacturing, along with strong skills in CAPA and risk management. The ideal candidate will lead audits, oversee supplier compliance, and collaborate with manufacturing operations. Fluency in English is essential for communication with international stakeholders.

Formación

• 7+ years of experience in medical device manufacturing or EMS.
• Proven experience leading FDA and customer audits.
• Experience in EMS or high-mix / low-volume medical manufacturing.

Responsabilidades

• Own and maintain the site Quality Management System (QMS).
• Lead FDA inspections and customer audits.
• Ensure robust risk management practices across manufacturing processes.

Conocimientos

Deep hands-on experience in regulated EMS environments

Strong background in CAPA and risk management

Fluent English

Educación

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

Herramientas

FDA 21 CFR 820 / QMSR

ISO 13485:2016

Descripción del empleo

This role ensures full compliance with FDA regulations (QMSR / 21 CFR 820), ISO 13485, and applicable international regulatory requirements, while acting as the primary interface with auditors, customers, and regulatory bodies. The ideal candidate brings deep hands‑on experience in regulated EMS environments and is comfortable operating at both strategic and tactical levels.

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
• 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.
• 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.).