Sr. Quality Engineer
hace 1 mes
**Vacancy Name**
- Sr. Quality Engineer
**Location of Work**
- Tijuana, Mexico
**Employment Type**
- Full Time Employee
- Supervisa los procesos y actividades de los Ingenieros de Calidad
- Administra las actividades de los QE para asegurar su cumplimiento en tiempo con el apoyo recibos QE de procesos.
- Ser el Coach y mentor de los QE trabajando en Recibos, Procesos y Cuarto Limpio.
- Controlar y mantener el sistema de calidad para cumplir con todos los requisitos reglamentarios aplicables, incluyendo los QSR de la FDA, ISO, Directiva de Dispositivos Médicos y otras normas y / o directrices aplicables.
- Revisar los informes y materiales de no conformidad con el personal de producción y de ingeniería para identificar acciones de corrección.
- Revisar los procesos de fabricación para desarrollar acciones preventivas.
- Asistir en las auditorías departamentales según las instrucciones.
- Realizar auditorías en el sitio de los proveedores según las instrucciones.
- Conducirse consistente con las normas de la empresa en todo momento durante las horas de trabajo o cuando actúa como representante de la empresa.
- Supervisar inspectores de control de calidad
- Crear y / o revisar procedimientos y criterios de prueba
- Dirigir el rastreo y las estadísticas de defectos, resultados de pruebas u otros datos de calidad reglamentaria
- Revisa y aprueba validación / calificación, Informes de Materiales y otros documentos de GC para el cumplimiento de las prácticas comerciales y los procedimientos y políticas departamentales según se requiera
- Generar y ejecutar validaciones / calificaciones relacionadas con procesos de control de calidad
- Participa en el procesamiento e investigación de quejas de clientes, manteniendo la documentación requerida.
- Realiza otros deberes relacionados asignados o requeridos.
- Computación ( Microsoft Office)
- Sistemas de documentación
- Capacidad para escribir informes de rutina y correspondencia.
- Capacidad para hablar eficazmente ante grupos de clientes o empleados de la organización.
- Capacidad para resolver problemas prácticos y tratar con una variedad de variables concretas en situaciones donde sólo existe una estandarización limitada.
- Capacidad para interpretar una variedad de instrucciones proporcionadas en forma escrita, oral, de diagrama
- Orientado al detalle
- Análisis
- Organización
- Comunicación Interpersonales
- Carrera Profesional
- De 4 a 6 años de experiência
- Ingles avanzado
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