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Software Quality Engineer

hace 4 meses

Tijuana, Baja California, México Foxconn Baja California, S.A. de C.V. A tiempo completo
y detalle de las actividades

Desarrollar y ejecutar planes de validación para sistemas computarizados conforme a normativas y regulaciones aplicables (por ejemplo, FDA, GAMP).

Crear y mantener documentación de validación, incluyendo Planes Maestros de Validación, Protocolos de Calificación (IQ, OQ, PQ) y Reportes de Validación.

Colaborar con los equipos de TI y de desarrollo para asegurar que los sistemas cumplan con los requisitos de funcionalidad y regulación.

Realizar evaluaciones de riesgo y análisis de impacto para determinar el alcance de la validación. Participar en auditorías internas y externas, proporcionando evidencia de conformidad y defensa de los procesos de validación. Gestionar el ciclo de vida de la validación de sistemas, incluyendo cambios y actualizaciones. Monitorear y reportar el estado de validación de los sistemas, identificando y resolviendo problemas de conformidad.

Experiência y requisitos

Licenciatura en Ingeniería Informática, Ciencias de la Computación, Ingeniería Biomédica o un campo relacionado. Experiência mínima de 3 años en validación de sistemas computarizados en un entorno regulado (farmacéutico, dispositivos médicos, etc.).

Conocimiento profundo de normativas y guías de cumplimiento como FDA 21 CFR Part 11, GAMP 5, ISO Experiência con herramientas de gestión de validación y documentación.

Fuerte capacidad para redactar y revisar documentación técnica y de validación. Excelentes habilidades de comunicación y colaboración. Capacidad para gestionar múltiples proyectos de validación simultáneamente. Atención al detalle y habilidades analíticas.

Número de vacantes 1

Área Calidad

Contrato Permanente

Modalidad Presencial

Turno Diurno

Jornada Tiempo Completo

Horario Lunes a viernes de 7:00am - 5:00pm

Salario mensual $ $45000 MXN

Estudios Titulo Profesional

Inglés Hablado: 80%, Escrito: 85%

Sexo Indistinto

Disponibilidad p. viajar No