Quality Engineer I

hace 5 meses

Nogales, México Avanos A tiempo completo

**PROPOSITO DE LA POSICION**

Realizar y revisar ejecución de validaciones de procesos/maquinas/sistemas para eficientizar el sistema de Aseguramiento de Calidad a través de herramientas estadísticas y de control de cambios para asegurar y mantener en cumplimiento el sistema de calidad basado en reducción de costos de manufactura, satisfacción al cliente y cumplimiento regulatorio.

**ROLES Y RESPONSABILIDADES**
- Aplicar y seguir las políticas de la empresa.
- Coordinar el desarrollo, revisar y aprobar los planes, protocolos y sumarios de validación de equipos, procesos y sistemas nuevos y existentes.
- Coordinar, revisar y aplicar los métodos de pruebas de inspecciones para materia prima, componentes, subensambles y producto final.
- Investigar, coordinar y contribuir en la aplicación de técnicas de resolución de problemas del sistema de acciones correctivas/preventivas.
- Analizar, investigar y dirigir en la administración y/o manejo de material no-conforme para mejoramiento continuo de los procesos de manufactura.
- Manejar, ejecutar, y controlar el equipo de calibración y prueba en base a los requerimientos para asegurar que las pruebas se realicen con medidas confiables en base a las normas.
- Aplicar, monitorear y mantener los controles ambientales para los procesos de manufactura basados en requerimientos aplicables al personal, vestimenta, limpieza, de almacenaje, envio y/o distribución de materiales, componentes y producto final.
- Mantener actualizados los estándares y/o especificaciones de calidad aplicables a procesos, materiales, componentes o productos final.
- Realizar y coordinar entrenamientos y/o capacitación basado en los procedimientos, regulaciones y especificaciones dentro del sistema de calidad.
- Aplicar, manejar y contribuir en las actividades de control de cambios y en la evaluación de proveedores y de reclamaciones de quejas de cliente.
- Coordinar y ejecutar los análisis de riesgo de proceso FMEA de manera activa y reflejando el estado y diseño aplicable de los procesos actuales.
- Realizar retroalimentación enfocada en resultados con su jefe inmediato.
- Recibir indicaciones, explicaciones y directrices de su líder o jefe inmediato, basado en principios y normas establecidas por disciplinas técnicas o científicas.
- Participar activamente en la reunión diaria del inicio de turno de su área asignada, también asegurar y mantener publicados y actualizados los métricos aplicables de aseguranza de calidad. Asi como atender diariamente situaciones rutinarias en los procesos bajo su responsabilidad.
- Revisar especificaciones/dibujos que cumplan con los requerimientos de los clientes como parte del sistema de calidad.
- Crear, actualizar y administrar Registro Maestro del Dispositivo (DMR) para nuevos y/o existentes productos.
- Participar en proyectos de desarrollo de nuevos/existentes productos, que impacten el mercado, para mantener el negocio competitivo.
- Implementar proyectos de ahorro de costos basado en análisis de tendencias y/o herramientas de mejoramiento continuo.
- Asegurar el escalar todos los problemas significativos a gerencias aplicables y personal de soporte para su resolución.
- Aplicar y contribuir en el seguimiento de las mejores prácticas de seguridad en el trabajo, incluyendo las inspecciones planeadas (BBS) e investigaciones para alcanzar los objetivos establecidos por la empresa.
- Cumplir con los entrenamientos asignados a la posición, de acuerdo con su matriz de entrenamiento, asi como asegurar que se encuentra entrenado antes de ejecutar una nueva actividad.
- Reportar peligros y lesiones al líder y/o supervisor inmediato.
- Cumplir con las reglas de seguridad e higiene y política ambiental.
- Participar activamente en el comité de seguridad e higiene y medio ambiente y brigadas para caso de emergencia en caso de ser necesario.
- Dar soporte al Gerente de Seguridad Higiene y Medio Ambiente con tiempo o asignando personal para las actividades de este sistema, cuando sea necesario.
- Asistir a los entrenamientos que sean programados por la empresa.

**Requisitos**:
**ESCOLARIDAD**: Profesional.

**INGLES**: Nível Avanzado

**EXPERIENCIA**:2 a 4 años en el área de Calidad y experiência en regulaciones para dispositivos médicos.

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