Manager, QA Compliance
hace 6 meses
**Company Description**
Supervisar el Laboratorio de Análisis de Quejas (DAL) y los departamentos de Revisión de Documentos (DHR), auditorías internas/externas y CAPA en Costa Rica con el objetivo de asegurar un funcionamiento eficiente y efectivo de los diferentes procesos y servicios que se brindan por medio de la realización oportuna de las tareas y cumpliendo con los lineamientos del Sistema de Calidad y entes regulatorios.
- Establecer, dirigir y coordinar los objetivos departamentales, métricas y sistemas departamentales, así como resolver conflictos y trabajar en coordinación con otros departamentos para asegurar el cumplimiento de los objetivos de la compañía
- Administrar el proceso de revisión de los DHR e investigaciones (FI) correspondientes a la manufactura de dispositivos médicos. Asegurar el cumplimiento de los requisitos regulatorios aplicables, los requisitos establecidos por el departamento de “Product Surveillance” y a su vez proveer información relevante al proceso productivo de dichos resultados.
- Administrar el proceso para el análisis de quejas recibidas por clientes externos correspondientes a la manufactura de “breast implants”. Asegurar el cumplimiento de los requisitos regulatorios aplicables y los requisitos establecidos por los clientes internos (Product Surveillance) y externos.
- Promover y apoyar iniciativas de mejora continua relacionadas a los procesos a cargo o introducción de nuevos productos con el objetivo de identificar y coordinar actividades requeridas propias de las áreas.
- Administrar el proceso de NCRs (CAPA) cumpliendo con los plazos y métricas establecidas por la compañía.
- Liderar el programa de auditoría interna del Sistema de Calidad de la planta, y asegurar la ejecución del mismo.
- Liderar la preparación y ejecución de las auditorías o inspecciones externas al Sistema de Calidad de la planta, organizando los recursos y documentación necesarios para una adecuada reacción a dichas auditorías o inspecciones.
- Cumplir con las demás funciones inherentes al cargo y aquellas asignadas por su jefe inmediato.
- Velar por la motivación de los colaboradores de las áreas asegurando que se refuerzan y reconocen oportunamente, de manera formal e informal, los comportamientos que promueve la cultura Abbvie.
- Definir y controlar el presupuesto de las áreas a cargo.
- Garantizar el cumplimiento de los requerimientos corporativos y legales de EHS, mediante el acatamiento de la política y los procedimientos internos. Así mismo, garantizar el cumplimiento mediante la adopción de estrategias, controles internos comunicación y entrenamientos necesarios.
- Mejorar continuamente los resultados de EHS a través del liderazgo, el compromiso y la participación activa en todas las iniciativas relacionadas con EHS.
- Liderar el programa de auditoría interna del Sistema de Calidad de la planta, y asegurar la ejecución del mismo.
- Liderar la preparación y ejecución de las auditorías o inspecciones externas al Sistema de Calidad de la planta, organizando los recursos y documentación necesarios para una adecuada reacción a dichas auditorías o inspecciones.
- Cumplir con las demás funciones inherentes al cargo y aquellas asignadas por su jefe inmediato
- Velar por la motivación de los colaboradores de las áreas asegurando que se refuerzan y reconocen oportunamente, de manera formal e informal, los comportamientos que promueve la cultura Abbvie.
- Definir y controlar el presupuesto de las áreas a cargo.
- Garantizar el cumplimiento de los requerimientos corporativos y legales de EHS, mediante el acatamiento de la política y los procedimientos internos. Así mismo, garantizar el cumplimiento mediante la adopción de estrategias, controles internos comunicación y entrenamientos necesarios.
- Mejorar continuamente los resultados de EHS a través del liderazgo, el compromiso y la participación activa en todas las iniciativas relacionadas con EHS.
**Qualifications**
- Bachillerato en Ingeniería Industrial, Administración de Empresas o carrera afín.
- Experiência de al menos 5 años en posiciones relacionadas dentro del sistema de calidad y deseable experiência en manejo de quejas en industria médica.
- Experiência de al menos 3 años en supervisión de personal.
- Manejo de Sistemas de Gestión de Calidad de dispositivos médicos ISO 13485:2016.
- Participación previa en auditorías de Calidad, preferiblemente del FDA o algún ente certificador de las normas ISO.
- Dominio de herramientas Lean como Value Stream Mapping, SMED, DMAIC.
- Nível B2 inglés.
**Deseable**
- Al menos un 50% de avance de la Maestría en carrera afín.
- Facilidad para el trabajo con programas en ambiente Windows, tales como Word, Power Point, Visio.
- Entrenamientos/certificaciones en las siguientes regulaciones:
- CMDR (Opcional)
- MHLW Ministerial Ordinance No. 169,2004 (Opcional)
- Medical Device Single Audit Program (MDSAP)
- FDA Inspections
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