Quality Manager

Foxconn Baja California, S.A. de C.V.; Tijuana; Presencial; MXN 1,249,000 - 1,607,000; Jornada completa

Descripción de la vacante

A leading manufacturing company located in Tijuana is seeking a Quality Manager to provide strategic quality leadership across manufacturing, validation, and supplier management. The ideal candidate will ensure product safety and compliance with regulatory standards while fostering a culture of quality and continuous improvement. Applicants should have at least 7 years of experience in the industry and hold a Bachelor's degree in a relevant field. This position offers the opportunity to influence quality practices in a dynamic environment.

Formación

• Bachelor’s degree in Engineering, Life Sciences, Quality, or a related field.
• 7+ years of quality experience in the medical device, pharmaceutical, or regulated healthcare industry.
• 3+ years in a quality leadership or management role.

Responsabilidades

• Provide strategic quality leadership across manufacturing and validation.
• Oversee complaint handling and ensure compliance with quality standards.
• Drive continuous quality improvements using data-driven metrics.

Conocimientos

Knowledge of FDA 21 CFR Part 820

Understanding of ISO 13485

Problem-solving skills

Effective communication

Leadership skills

Risk management

Educación

Bachelor’s degree in Engineering, Life Sciences, Quality

Master’s degree preferred

Herramientas

ASQ Certified Quality Manager (CQM)

Lean Six Sigma certification

Descripción del empleo

Position Summary

Responsible for providing strategic and hands-on quality leadership across manufacturing, validation, supplier management, and continuous improvement activities to ensure product safety, effectiveness, and regulatory compliance with the Quality Management System (QMS), FDA 21 CFR Part 820, ISO 13485, and other global regulations.

Key Responsibilities

Manufacturing & Process Quality

• Ensure appropriate validation activities are executed and maintained (IQ/OQ/PQ, process validation, equipment qualification).
• Lead investigations related to non-conformances, deviations, and CAPAs using risk-based methodologies.
• Support PFMEA/DFMEA activities and risk management per ISO 14971.

Complaint Handling & Post-Market Surveillance

• Oversee complaint handling, trending, and escalation processes.
• Ensure timely reporting of adverse events (e.g., MDRs, vigilance reporting) when applicable.

Quality Management System (QMS)

• Develop, implement, maintain, and continuously improve the Quality Management System in compliance with FDA, ISO 13485, and applicable international regulations.
• Ensure effective document control, record retention, and change management (ECR/ECO).

Regulatory & Compliance

• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, ISO 14971, and other applicable standards.
• Serve as the primary quality representative during FDA inspections, ISO audits, and customer audits.

Supplier Quality Management

• Establish and maintain supplier qualification, monitoring, and audit programs.
• Ensure supplier compliance with quality and regulatory requirements.

Leadership & People Management

• Lead, coach, and develop quality team members.
• Foster a culture of quality, compliance, and continuous improvement.

Continuous Improvement

• Drive quality improvements using data-driven metrics (yield, DPPM, CAPA effectiveness).
• Promote risk-based decision making throughout the organization.

Education

• Bachelor’s degree in Engineering, Life Sciences, Quality, or a related field (Master’s preferred).

Experience

• 7+ years of quality experience in the medical device, pharmaceutical, or regulated healthcare industry.
• 3+ years in a quality leadership or management role.
• Direct experience with FDA inspections and ISO 13485 audits.
• Strong background in manufacturing quality and validation.

Skills & Competencies

• In-depth knowledge of FDA 21 CFR Part 820 and ISO 13485.
• Strong understanding of risk management (ISO 14971, FMEA).
• Problem-solving, root cause analysis skills & hands-on issue solving.
• Effective written and verbal communication.
• Strong leadership and stakeholder management skills.
• Ability to balance compliance, risk, and business objectives.

Preferred Certifications

• ASQ Certified Quality Manager (CQM)
• ASQ Certified Quality Engineer (CQE)
• Lean Six Sigma (Green Belt or Black Belt)

Working Conditions

• May require occasional travel for customer visits.
• Manufacturing and cleanroom environments required.