Document Specialist
hace 7 días
**Importante empresa de carácter internacional, busca un Document Specilict**
INDISPENSABLE TENER:
1. Experiência requerida: Documentación de la industria de **DISPOSITIVOS** **MÉDICOS **, experiência en sistemas de control de cambios.
2. Educación: Ingeniería (o equivalente), Ingeniería Mecánica / Biomédica/ Ingeniero industrial, Químico.
3. **Inglés **, comprensión del idioma por el tipo de documentación con la que se trabajará. (Entender y escribir) (Será evaluado en entrevista)
**Habilidades técnicas / funcionales**:
- Excelente conocimiento y uso de las aplicaciones de MicroSoft Word, Excel y PowerPoint.
- Experiência en la industria de la gestión de la documentación en un entorno cGMP. Entorno regulado por la FDA/ISO
- Comprensión de los procedimientos operativos estándar y de los sistemas generales de documentación
- Habilidades de estructuración de la lista de materiales, configuración de atributos de la pieza, configuración del router en el sistema
- Comprender, utilizar y mantener plantillas de documentos
- Actividades de gestión de cambios
- Experiência en la redacción de procedimientos operativos estándar e instrucciones de trabajo
- Debe ser capaz de leer y entender las especificaciones de los componentes/productos. Es deseable el conocimiento de GD&T.
- Fuertes habilidades de comunicación, tanto oral como escrita, para comunicarse eficazmente con los clientes y las partes interesadas internas
- Capacidad para trabajar eficazmente en un entorno de equipo interfuncional y crear relaciones de trabajo sólidas
- Gestión eficaz del tiempo y habilidades de organización.
- Contribuir como representante de documentación en equipos de proyectos interfuncionales
- NC, familiaridad con el sistema CAPA, métricas de calidad, trens y generación de informes.
**Responsabilidades**:
- Realizar actividades de creación, revisión y formateo de documentos.
- Comprobar el formato y la conformidad con las plantillas de los documentos. Utilizar procesos, herramientas y listas de verificación internas para realizar el formateo de los documentos para cumplir con los estándares y requisitos técnicos requeridos.
- Colaborar con los propietarios de los documentos para apoyar la generación de documentos con el formato adecuado, desde el borrador hasta el final, para cumplir con los plazos especificados.
- Estructura de la lista de materiales, configuración de los atributos de las piezas, configuración del router en el sistema según las instrucciones
- Apoyo a la gestión de proyectos según sea necesario
- Apoyo a las actividades de ingeniería y documentación relacionada con la calidad
- Apoyo a la anyasis de datos según sea necesario, apoyo a la elaboración de informes
- Soporte de creación de impresión según sea necesario
Ofrecemos:
Lugar de trabajo: Coyol, Costa Rica (zona franca)
Estabilidad laboral
Prestaciones de ley
Sueldo: 850,000 Colonos Brutos
Tipo de puesto: Tiempo completo, Por contrato
Tipo de puesto: Tiempo completo
Experiência:
- Industria de dispositivos Médicos: 2 años (Obligatorio)
- Documentación: 2 años (Obligatorio)
Idioma:
- Inglés (Obligatorio)
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