Post Market Quality Analyst 2 CR

hace 2 semanas


Alajuela, Alajuela, Costa Rica Hologic, Inc. A tiempo completo
Education / Educación:
  • 50% de la totalidad de aprobados del título universitario en Ingeniería o carrera relacionada.
Experiencia / Experiencia:
  • No es necesario tener experiencia.
Conocimiento Especializado (Deseable) / Conocimiento especializado (preferible):
  • Regulaciones de la FDA (Incluido el MDR para la Guía de Fabricantes), ISO 13485, ISO 14947, directivas de la UE sobre DM y MDR y cualquier norma relacionada de ISO y AAMI. Cualificación de equipos. Buenas prácticas de laboratorio. Desarrollo de métodos de prueba y procedimientos. Idiomas requeridos para el puesto (Deseable) / Idiomas requeridos para el puesto (preferible): Español/Inglés (nivel avanzado). Herramientas informáticas y nivel de conocimiento requerido: Microsoft Office, Internet, Minitab, Oracle, Agile.
Resumen de Funciones y Responsabilidades:
  • Apoyar el programa de Excelencia Operativa e iniciativas. Apoyar a los CSPOs locales y extendidos, proyectos VIP, iniciativas de mejora, NPIs, transferencias de productos, implementación de nuevas tecnologías. Controlar las métricas y los informes de calidad de clase mundial relacionados con los implementados en el Laboratorio de Vigilancia del Mercado Posterior. Innovar procesos para mejorar la eficiencia y garantizar el cumplimiento de los requisitos de Vigilancia del Mercado Posterior. Mantener, mejorar y simplificar procedimientos, procesos y métodos. Apoyar y promover la implementación de programas de EHS para garantizar la seguridad de las personas y la salud del medio ambiente. Coordinar servicios con proveedores y disponibilidad de los suministros requeridos en casa (según corresponda). Coordinar y garantizar que los pagos requeridos a los proveedores se realicen a tiempo. Asegurar que las pruebas y las investigaciones se realicen de acuerdo con los procedimientos y de manera oportuna. Apoyar el seguimiento y análisis de quejas. Crear y ejecutar nuevos procedimientos, nuevos métodos de prueba, validaciones y cualquier otro requisito de cumplimiento. Tomar decisiones basadas en un pensamiento de riesgo, implementar herramientas como PFMEA, Análisis de Árbol de Fallos (FTA) y evaluación de riesgos. Revisar y aprobar investigaciones de quejas en el SGIC, según sea necesario. Asegurar que el equipo esté correctamente calibrado y controlado con el SGIC. Asegurar que el programa de Mantenimiento Preventivo se implemente según sea necesario. Brindar orientación a CSPOs, inspectores, técnicos, supervisores e ingenieros en asuntos técnicos relacionados con la Vigilancia del Mercado Posterior. Realizar investigaciones como OOTs, NCEs, CAPAs, IACAs y/o similares. Asegurarse de que se realicen a tiempo, cumpliendo con los procedimientos y las regulaciones. Escalar a los Especialistas Clínicos y al Gerente de PMS en caso de que haya algún Evento Adverso Potencial.
Calificaciones:
  • Resultados de conducción. Planificación. Agilidad organizativa. Escucha. Toma de decisiones. Resolución de problemas. Comunicación.

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