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Quality and Hse Engineer
hace 4 semanas
Únete a nuestro equipo como
**Quality and HSE Engineer**
ESP-Mataró (Barcelona)
Aprovecha la nueva oportunidad que te ofrece HARTMANN en el **Área de Calidad**.
**Responsabilidades**
- Gestionar los procedimientos, así como la documentación del sistema de Calidad, Medio Ambiente y Seguridad de la empresa según las normativas aplicables (ISO 9001, ISO 13485, ISO 14001, EMAS, ISO 45001, FDA).
- Cumplimiento de requerimientos legales en materia de productos sanitarios conforme Directiva 93/42/CE y Reglamento 2017/745/EU, y de igual forma los asociados a Medio Ambiente y PRL.
- Elaborar y coordinar los planes de control de los distintos procesos asociados a Calidad, Medio Ambiente y/o Seguridad, según necesidades de la empresa.
- Controlar y analizar las no conformidades internas y de proveedores, los costes asociados, así como propuestas de acciones de mejora y actuaciones en origen para minimizarlas.
- Hacer seguimiento y controlar las acciones de mejora y de las auditorías internas y externas. Auditor/a interno/a designado/a para ejecución de auditorías periódicas tanto internas como a proveedores.
- Monitorización y gestión de CAPAs y Change Control de documentación así como de producto aprobados localmente.
- Control y seguimiento de los accidentes de trabajo, así como del plan de prevención y evaluación de riesgos en coordinación con el SPA.
- Formar, informar y sensibilizar al personal de la empresa en materia de calidad, medio ambiente y seguridad.
- Gestionar e implementar los planes de calibración de los equipos de laboratorio y monitorización de otros equipos de control de fábrica.
- Gestión de EPIs de la empresa.
- Hacer cumplir las normativas de Calidad, Política de higiene (GMP), PRL, Medio Ambiente, IFS.
- Liberación de lotes de producto acabado: estéril; no estéril y Direct Deliveries. Gestión de incidencias relacionadas y contacto con proveedores.
- Respetar e implementar la Normativa de Medio Ambiente y Procesos Asociados (Gestión de Residuos, Identificación de no conformidades ambientales, Identificación de Productos Químicos, entre otros).
- Gestionar los proyectos de Validación y Recualificación del Proceso de Esterilización. Gestión de incidencias y tareas en rutina relacionadas con el proceso de Esterilización.
- Gestión de personas a cargo siguiendo la normativa e instrucciones de la empresa.
- Coordinación de actividades empresariales por parte de contratistas, contacto con proveedores y revisión documental.
- Gestión y análisis del contexto de la organización así como de sus Riesgos y Oportunidades y las acciones asociadas.
- Leadership Process House Project Spain.
- Proponer activamente iniciativas de mejora y participar en los proyectos de innovación y excelencia cuando sea preciso.
**¿Qué estamos buscando?**
- Estudios de Ingeniería Técnica, Biomédica o Industrial así como grado o máster en Prevención de Riesgos Laborales.
- 2 años de experiência en un puesto similar
- Se valorarán conocimientos en sistemas de gestión ISO 9001, ISO 14001, ISO 13485, EMAS, ISO 45001, ISO 19011, ISO 11135, entre otros.
- Nível de inglés intermedio
¿Estás preparado para formar parte de una compañía internacional con un posicionamiento clave en el mercado? Entonces anímate a seguir con tu carrera profesional en HARTMANN. Nuestro mayor potencial es invertir en el desarrollo de nuestros colaboradores.
Departamento**:Calidad
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