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Quality Management Systems (QMS) Coordinator
Foxconn Baja California, S.A. de C.V.
Tijuana, Baja California
Julio 15 2026
Compartir:
Corporativo
Giro
Manufacturera
Actividad principal
Electronics & MedTech
Número de empleados
5000
Sitio Web corporativo
Sitio Web
Descripción y detalle de las actividades
- Develop, implement, and continuously improve quality testing methods, inspection plans, documentation, and test procedures.
- Implement and maintain the Quality Management System (QMS) in compliance with ISO 13485 and FDA QMSR requirements.
- Lead or support the implementation and transition to the FDA Quality Management System Regulation (QMSR).
- Manage quality system processes, including CAPAs, NCMRs, Customer Complaints, Deviations, Risk Management, ECOs, and Document Control.
- Establish, monitor, and report Quality KPIs, including CAPAs, NCMRs, Customer Complaints, Audit Metrics, Supplier Quality, and Management Review.
- Lead recurring CAPA, NCMR, Management Review, and Quality KPI meetings, ensuring timely follow-up and closure of action items.
- Support validation activities, First Article Inspections (FAI), product inspections, material releases, and continuous improvement initiatives.
- Plan, conduct, and support internal, external, customer, and regulatory audits.
- Lead root cause investigations using 8D, 5 Why, Fishbone, DMAIC, or similar methodologies.
- Prepare quality reports, KPI dashboards, and executive presentations for senior management.
- Collaborate with Manufacturing, Engineering, Regulatory Affairs, Operations, and Supply Chain to improve product quality and regulatory compliance.
- Lead, supervise, coach, and develop Quality Engineers, Technicians, and Inspectors, including workload management and performance evaluations.
Experiencia y requisitos
- Bachelor’s degree in Industrial Engineering, Quality Engineering, or related field.
- Minimum 3 years of experience in QMS within the medical device industry.
- Strong knowledge of:
- ISO 13485
- CAPA systems
- Internal and external audits
- Root cause analysis
- Quality system documentation
Advanced English (required).
Beneficios
Número de vacantes 1
Área Calidad
Contrato Permanente
Modalidad Presencial
Turno Diurno
Jornada Tiempo Completo
Estudios Carrera con título profesional
Inglés Hablado: Avanzado, Escrito: Avanzado
Disponibilidad p. viajar No
