Sr Quality System Engineer
hace 1 mes
**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.
- Implementa y respalda metodologías y sistemas que mejoran la calidad del producto y el sistema de calidad (Revisión gerencial, Entrenamiento de las Regulaciones del Sistema de Calidad, ISO13485).
- Ayuda a la administración de las operaciones de la organización y del grupo a planificar e implementar las acciones correctivas necesarias para garantizar el cumplimiento continuo de la política y los procedimientos de la división, las regulaciones federales bajo el Título 21 CFR Parte 820 e ISO 13485. Asegura que el sistema CAPA sea de seguimiento y sea efectivo
- Planifica, organiza, implementa y hace un seguimiento para asegurarse de que el Programa de Auditoría Interna esté implementado y sea efectivo. Realiza auditorías internas de rutina del sistema de calidad de acuerdo con los procedimientos de la división. Informa los resultados de la auditoría tanto a la gerencia organizacional como a la alta gerencia.
- Asiste al. Gerente Q.A en el desarrollo, documentación, implementación y mantenimiento de procedimientos, instrucciones y registros del sistema de calidad.
- Trabaja con la administración del departamento correspondiente para iniciar las acciones correctivas necesarias para resolver los problemas relacionados con la calidad identificados como resultado del análisis de rutina de los datos de rendimiento del producto.
- Informa sobre los resultados a tiempo del Programa de Auditoría Interna y el sistema CAPA (RMN, FI, Quejas) que impulsarán la mejora continua.
- Puede participar en la elaboración de presupuestos de objetivos, formación y desarrollo.
- Participa y respalda el proceso de mejora de la calidad de Welch Allyn según lo requiere la alta dirección. Apoya y ayuda a implementar los Principios de Calidad de Welch Allyn participando activamente en la prevención de errores y la resolución de problemas.
- Puede actuar como coordinador de la CAPA.
- Es miembro de la Junta de Revisión de CAPA, que actúa como responsable de la supervisión del sistema CAPA de la organización y garantiza que se establezca y se mantenga.
**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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