Jr Validation Engineer
hace 6 meses
Importante empresa Internacional se encuentra en la búsqueda de un Ingeniero especializado ( con ampia experiência) en insumos médicos, de acuerdo a la siguiente descripción:
Experiência:
Se prefiere más de 3 a 4 años de experiência y competencia demostrada en la validación de procesos/equipos y en brindar soporte técnico continuo con evidencia de autodesarrollo continuo.
Experiência laboral en la industria de Dispositivos Médicos.
Habilidades Técnicas/Funcionales
Conocimiento de los procesos de fabricación de Equipos Médicos.
- GMP (Buenas Prácticas de Manufactura) e ISO (Organización Internacional de Normalización) 9000 y asuntos regulatorios
- Capacidad para especificar y calificar equipos de montaje, herramientas, equipos de medición y accesorios.
- Conocimientos en las áreas de Validación de Procesos, Control Estadístico de Procesos, Diseño de Producto y DFMA (Diseño para Fabricación y Ensamblaje), Materiales y procesamiento plásticos y metálicos y Estadística Aplicada.
- Conocimiento del sistema de software de dibujo como AutoCAD y Solidworks.
- Capacidad demostrada para interpretar los dibujos de ingeniería, es decir, GD&T (Dimensionamiento y tolerancias geométricas)
- Conocimiento de los procesos productivos.
- Buena comunicación oral y escrita en español e inglés, preferentemente.
- Capacidad para trabajar e interactuar con compañeros de trabajo para lograr los objetivos de la empresa en un ambiente de equipo.
- Capacidad para trabajar en un entorno estresante/de ritmo rápido
Experiência Requerida
Conocimiento demostrado de los principios, prácticas y procedimientos de fabricación.
- Se preferirá experiência en BWI o Johnson & Johnson.
- Experiência laboral en la industria de dispositivos médicos
Roles y responsabilidades
Según (por ejemplo, supervisión limitada, dirección general, etc.) y de acuerdo con todas las leyes/regulaciones federales, estatales y locales aplicables y los procedimientos y directrices de Johnson & Johnson corporativo, este puesto:
Llevar a cabo reuniones para desarrollar estrategias y soluciones con un equipo multifuncional.
- Puede guiar en el proceso de Validación, liderar la redacción y revisión de protocolos e informes de prueba.
- Puede ofrecer soporte en sitio durante la fase de ejecución de validaciones (IQ, OQ, PQ).
- Puede redactar una estrategia de validación, incluidas las de TMV.
- Puede calificar los primeros artículos, completar estudios de capacidad de procesos y validación de procesos tanto en procesos internos como de proveedores utilizando técnicas estadísticas apropiadas.
- Puede respaldar actividades de gestión de cambios utilizando la herramienta PLM de la organización.
- Preparar informes según los requisitos del proyecto.
- Puede supervisar, coordinar y revisar técnicamente el trabajo de un grupo limitado de técnicos.
- Responsable de garantizar que los subordinados sigan todas las pautas de la Compañía relacionadas con las prácticas de Salud, Seguridad y Medio Ambiente y que todos los recursos necesarios para hacerlo estén disponibles y en buenas condiciones.
- Responsable de comunicar problemas u oportunidades relacionados con el negocio al siguiente nível de gestión.
- Responsable de garantizar el cumplimiento personal y de la empresa de todas las regulaciones, políticas y procedimientos federales, estatales, locales y de la empresa.
- Realiza otras tareas asignadas según sea necesario
Formación Académica
- Se requiere Ingeniería en cualquier especialidad
- De 3 a 4 años de experiência en validación de productos sanitarios.
Ubicación: Costa Rica, San José
Tipo de puesto: Tiempo completo
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