Documentation Control File Technician
hace 2 meses
**This is where you save and sustain lives**
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
**Objetivo principal del puesto**:
Dar soporte y ejecutar actividades establecidas al Departamento de Documentación en cumplimiento al Sistema de Gestión de Calidad, es responsable de digitalizar y resguardar correctamente los registros generados que dan soporte a la operación de la planta.
**Principales Actividades y Responsabilidades**:
Vigilar el cumplimiento de los requisitos de la regulación FDA de países a donde se exporta el producto, estándares internaciones ISO 13485 y requisitos corporativos, así como también, dar cumplimiento al proceso de la administración del riesgo cuando aplique. Brindar atención significativa y cooperación en Auditorías internas y externas del SGC. Asiste a las reuniones de entrega de documentación para resguardo y funge como representante del departamento de Documentación. Administra la custodia de manera ordenada y clasificada para el fácil acceso de búsqueda y consulta tanto de los documentos físicos como en el sistema electrónico para cada área. Garantiza que el alta, cambios y bajas de documentos se realicen mediante la administración efectiva del sistema de control de documentación. Digitaliza todo documento que recibe para resguardo del archivo electrónico y físico de la información (DHRs, protocolos de validaciones y documentos regulatorios que apliquen). Asegura los periodos de retención correctos para los documentos dentro del archivo físico, de acuerdo a las políticas y procedimientos relacionados. Actualiza el archivo sistematizado (electrónico) con la información de la documentación que entra al área de resguardo, para demostrar el grado de cumplimiento y conformidad con el Sistema de Gestión de la Calidad. Apoya el cumplimiento del Sistema de Calidad mediante su participación para realizar actividades adicionales y requeridas por el jefe inmediato. Cumplir con los sistemas de Seguridad e Higiene, ISO 14001 (Gestión Ambiental) y de acuerdo a la NOM-041, así como los que apliquen. Aplicar y seguir los lineamientos de EHS de acuerdo con los procedimientos establecidos, estándares y normas oficiales mexicanas. Usar el equipo de protección personal (EPP) asignado de acuerdo con la NOM-017.
**Reasonable Accommodations**
**Recruitment Fraud Notice**
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
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