Supervisor, Complaint Processing Analyst

hace 4 semanas


Heredia, Costa Rica ABBVIE A tiempo completo

**OBJETIVOS**:
Brindar soporte el equipo global de procesamiento de quejas y consultas de clientes internos y externos

sobre dispositivos médicos y quejas tales como agentes de venta, representantes de ventas, sitios de

manufactura, comercial, hospitales o bien médicos, además de dirigir al equipo de analistas asegurando el

cumplimiento de los requisitos regulatorios en el proceso como también un adecuado desempeño del

equipo. Adicionalmente, deberá garantizar el cumplimiento de los procedimientos corporativos como

también la calidad del producto, satisfacción del cliente además de mantener el sistema de calidad

velando así mismo por la rentabilidad del mismo proceso.

**RESPONSABILIDADES**:

- Proporcionar dirección diaria al equipo local de analistas que se encarga del procesamiento de las

quejas. Tener una perspectiva centrada en el futuro para garantizar que se adelanten a tendencias
- Gestionar la aplicación de políticas, procedimientos, lanzamientos de nuevos productos que impacten el departamento de procesamiento de quejas
- Proveer soporte como experto de procesamiento de quejas en auditorías internas y externas
- Garantizar que los registros de quejas cumplen los requisitos correspondientes y asegurarse de que el equipo se mantiene al día de las obligaciones vigentes
- Liderar los controles internos para asegurar cumplimiento de desempeño requerido para el equipo a cargo
- Proveer soporte cuando sea requerido en otras áreas funcionales del departamento de PMQA tales como Intake o reporting.
- Ejecutor de actividades de calidad tales como CAPAs, auditorías internas, control de cambios o procedimientos.
- Asegurar el desarrollo de su personal a cargo a través de las herramientas proveídas por la organización
- Preparar y presentar datos relacionados con quejas de producto
- Asegurar la mejora continua relacionada con el control de errores en la integridad de datos a través de buenas prácticas de documentación

**EDUCACIÓN**:

- Bachiller universitario en carreras tecnológicas, ingeniería, o con algún enfoque científico tales como: química, farmacia, biología, microbiología.
- Conocimiento intermedio-Avanzado (B2**+**)
- Administración del talento - Toma de decisiones - Resolución de problemas - Negociación - Comunicación - Conocimiento técnico en regulaciones/normas: FDA 21 CFR part 803, 820, EU MDR, ISO 13485:2016 (Preferible)

**EXPERINCIA**:

- Experiência laboral de al menos 5 años en industria regulada de dispositivos médicos (GMPs) y calidad
- Experiência laboral de al menos 1 año supervisando de personal
- Experiência en ejecución de proyectos



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