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Manufacturing Engineer Ii
hace 3 semanas
Requisitos:
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.
Habilidades técnicas / Requisitos
Evaluaciones de normalidad, análisis de capacidad, test t de 2 muestras, ANOVAs y GR&Rs, etc.)
Conocimiento práctico de las pautas cGMP, FDA 21 CFR Part 820, 210, 211, pautas ICH
Desarrollo de un procedimiento estándar (SP), instrucciones de trabajo (WI) relacionadas, formularios, listas de verificación, protocolos, informes y plantillas para instalaciones / servicios públicos, puesta en servicio del almacén y actividad de calificación.
Comprensión de los principios, dispositivos y procedimientos neurovasculares
Experiência con catéteres de balón y / o dispositivos de administración
Experiência con dispositivos de Nitinol y métodos de procesamiento.
Experiência en transferencia de productos y procesos.
Actividades a realizar:
Reunir el equipo necesario, herramientas, información de los aparatos, especialización. Revisar el equipo más antiguo para ver si hay lagunas y las modificaciones necesarias, si las hay. Verificar el equipo para asegurar 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
Ofrecemos:
Estabilidad laboral
Prestaciones de ley
Sueldo atractivo: 1,300,000 brutos
Tipo de puesto: Tiempo completo, Contrato inicial por 1 año, probabilidad de extensión
CONDICIONES DEL EMPLEO
Jornada laboral:Tiempo Completo
Tipo de empleo:Trabajo Fijo
Salario:A convenir
Cantidad de vacantes:1
REQUERIMIENTOS
Experiência Mínima:3 años
Idiomas:Inglés Avanzado
Estudios Mínimos:Licenciatura
Sexo:Indistinto
