Validation Specialist
hace 2 semanas
Buscamos un especialista en validación en nuestra empresa Gsb, con experiencia en dispositivos médicos.
**Experiencia**:
Se requiere experiencia de al menos 4 años en validación de procesos y equipos, con habilidades técnicas en GMP (prácticas de manufactura buena) e ISO 9000 y asuntos regulatorios. Se valoran habilidades en especificación y calificación de equipo de ensamblaje, herramientas, equipo de medición y accesorios.
**Habilidades técnicas**:
Conocimiento de los procesos de manufactura de equipos médicos
- GMP e ISO 9000 y asuntos regulatorios
- Habilidades en especificación y calificación de equipo de ensamblaje, herramientas, equipo de medición y accesorios.
- Conocimiento en áreas de validación de procesos, control de procesos estadísticos, diseño de productos y DFMA (diseño para manufactura y ensamblaje)
, materiales plásticos y metálicos y procesamiento, y estadísticas aplicadas. Conocimiento de sistemas de software de dibujo como AutoCAD y Solidworks.
- Habilidad para interpretar dibujos de ingeniería, es decir, GD&T (dimensionamiento geométrico y tolerancias)
- Conocimiento de procesos de producción.
**Habilidades de comunicación**:
Habilidad para comunicarse oral y escritamente en español e inglés, preferiblemente.
- Habilidad para trabajar y interactuar con compañeros de trabajo para lograr objetivos de la empresa en un entorno de equipo.
- Habilidad para trabajar en un entorno estresante y de alta velocidad.
**Experiencia requerida**:
Conocimiento demostrado de principios, prácticas y procedimientos de manufactura.
- Experiencia en Johnson & Johnson, preferiblemente.
- Experiencia en la industria de dispositivos médicos.
**Roles y responsabilidades**:
Según (por ejemplo, supervisión limitada, dirección general, etc.) y de acuerdo con todas las leyes federales, estatales y locales aplicables y procedimientos y directrices de la empresa Gsb, esta posición:
Conduce reuniones para desarrollar estrategias y soluciones con un equipo interfuncional.
- Puede guiar el proceso de validación, liderar la redacción y revisión de protocolos y informes de prueba.
- Puede ofrecer apoyo en sitio durante la fase de ejecución de validación (IQ, OQ, PQ). Puede escribir una estrategia de validación, incluida la TMV.
- Puede calificar primeros artículos, completar estudios de capacidad de proceso y validación de proceso en procesos internos y de proveedores utilizando técnicas estadísticas apropiadas
- Puede apoyar actividades de gestión de cambios utilizando la herramienta PLM de la organización
- Prepara informes según los requisitos del proyecto
- Puede supervisar, coordinar y revisar técnicamente el trabajo de un grupo limitado de técnicos
- Es responsable de asegurarse de que los subordinados sigan todas las directrices de la empresa relacionadas con la salud, la seguridad y el medio ambiente y de que estén disponibles y en buen estado todos los recursos necesarios para ello
- Es responsable de comunicar problemas o oportunidades comerciales a los niveles siguientes de gestión
- Es responsable de asegurarse de que se cumplan todas las regulaciones, políticas y procedimientos federales, estatales, locales y de la empresa
- Realiza otros deberes asignados según sea necesario
**Habilidades de gestión**:
Experiencia en gestión de proyectos
Debido a la naturaleza dinámica de esta posición, el candidato seleccionado deberá estar dispuesto a aprender y adaptarse a nuevas tareas y responsabilidades.
**Formación académica**:
- Se requiere formación en ingeniería en cualquier especialidad
**Ubicación**: San José, Costa Rica
Tipo de puesto: Tiempo completo
Experiencia:
4 años en productos médicos (Requerido)
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