Software Validation Engineer (CSV)

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

Tijuana, Baja California

Hace 6 horas

Corporativo

Giro

Manufacturera

Actividad principal

Electronics & MedTech

Número de empleados

5000

Sitio Web corporativo

Sitio Web

Descripción y detalle de las actividades

• Execute and lead computerized systems validation activities under GAMP 5

• Develop and review validation documentation: URS, FS, DS, IQ, OQ, PQ

• Ensure regulatory compliance with 21 CFR Part 11 / 820

• Coordinate functional, integration, and system validation testing (MES, eDHR, ERP)

• Manage deviations, CAPAs, and change control related to validated systems

• Collaborate with IT, Quality, and Manufacturing teams to implement digital solutions

• Participate in internal and external audits (FDA, ISO)

• Perform risk assessments and define risk-based validation strategies

• Support system release and maintain validated state

Experiencia y requisitos

• +3 years of experience in Computerized Systems Validation (CSV)

• Experience in the medical device industry or other highly regulated environments

• Knowledge of FDA regulations and ISO 13485

• Professional English proficiency

• Experience with digital tools such as MES, eDHR, or ERP systems (preferred)

Beneficios

Número de vacantes 1

Área Calidad

Contrato Permanente

Modalidad Presencial

Turno Diurno

Jornada Tiempo Completo

Horario

Estudios Carrera con título profesional

Inglés Hablado: Intermedio, Escrito: Avanzado

Disponibilidad p. viajar No