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Sr. Manufacturing Engineer

hace 2 semanas

Alajuela, Costa Rica Global Services Business A tiempo completo

Importante empresa de carácter internacional, busca un Ingeniero en Manufactura con experiência requerida en la industria de DISPOSITIVOS MÉDICOS. Indispensable : +4-5 años con experiência requerida en la industria de DISPOSITIVOS MÉDICOS, Educación finalizada en: Ingeniería Mecánica / Biomédica/ Ingeniero industrial, Químico, etc. Idioma: Inglés (será evaluado en entrevista). Deberá comprender el idioma por la documentación que se maneja en inglés. Responsabilidades: Reunir el equipo necesario, herramientas, información de los aparatos, especialización. Revisar el equipo más antiguo para ver si hay lagunas y ejecutar modificaciones necesarias, si las hay. Verificar el equipo asegurando su idoneidad/orden para el propósito previsto. Coordinar para presentar la orden de compra - obtener su orden. Revisar y evaluar la capacidad del proceso de mfg., Cpk, Ppk, robustez y caracterización. Revisar la caracterización para asegurar su validez y encontrar la ventana para la recaracterización. Crear un mapa de calor para mostrar los datos recogidos. Documentar el rendimiento, la producción. Validar el mfg, los procedimientos de prueba e inspección cuando sea apropiado: Identificación y reparación de las lagunas del proceso de GFG. 4. Observar el proceso/construcción actual de la GFM, estudiar el procedimiento aplicable de la GFM, identificar los vacíos, marcar los procedimientos aplicables, implementar los cambios en el SGC por el proceso de CO. Revisar los documentos de validación de la OQ, PQ y PPQ del equipo y del proceso de GFG, revisión de los riesgos del proceso. Estudiar el proceso de mfg. para documentar los procesos altamente dependientes del operador o cuán manual es el proceso. Crear un mapa representativo codificado por colores para planificar el tipo y la extensión de la capacitación requerida Recopilar los documentos del DMR, revisarlos para asegurar su integridad. Revisar los cambios en la etiqueta y en el IFU, documentar los cambios a implementar

Empresa líder en tecnología, soluciones y servicios médicos.

**Requisitos**:
Beneficios

**Lugar de trabajo**: Coyol, Costa Rica Estabilidad laboral Prestaciones de ley Tipo de puesto: Tiempo completo, Por contrato