Quality Systems Engineer

Foxconn Baja California, S.A. de C.V.

Tijuana, Baja California

Mayo 21 2026

Corporativo

Giro

Manufacturera

Actividad principal

Electronics & MedTech

Número de empleados

5000

Sitio Web corporativo

Sitio Web

Descripción y detalle de las actividades

Provide quality support to production lines and catheter assembly processes
Ensure compliance with GMP, GDP, and ISO 13485 requirements
Investigate NCRs, process deviations, and manufacturing failures
Lead root cause analysis activities using 8D, 5 Why’s, Fishbone, and CAPA methodologies
Monitor quality KPIs, scrap trends, and rework performance
Support process validations, engineering changes, and continuous improvement initiatives
Participate in internal, corporate, and regulatory audits
Collaborate with Manufacturing, Process Engineering, Validation, and Quality teams

Experiencia y requisitos

Bachelor’s degree in Engineering or related field
2–3 years of experience as a Quality Engineer within the medical device industry
Experience in catheter manufacturing or medical device assembly operations
Knowledge of ISO 13485, FDA 21 CFR Part 820, and document control systems
Hands-on experience supporting high-volume production floor operations
Intermediate to advanced English level

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