Quality Leader

hace 2 semanas

Tijuana, México BAXTER A tiempo completo

**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.

**ACTIVIDADES PRINCIPALES Y RESPONSABILIDADES - ESSENTIAL DUTIES AND RESPONSIBILITIES**:

- Alcanza los objetivos operativos de calidad mediante la contribución de información y análisis a planes estratégicos y revisiones; preparar y completar planes de acción; implementando estándares de producción, productividad, calidad y servicio al cliente; identificando y resolviendo problemas; realizar auditorías; determinando mejoras del sistema; implementando el cambio. _Achieves quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and customer-service standards; identifying and resolving problems; completing audits; determining system improvements; implementing change._
- Cumple con los objetivos financieros de aseguramiento de calidad mediante la estimación de los requisitos; preparar un presupuesto anual; programación de gastos; análisis de variaciones; iniciando acciones correctivas. _Meets quality assurance financial objectives by estimating requirements; preparing an annual budget; scheduling expenditures; analyzing variances; initiating corrective actions. _
- Mantiene y mejora la calidad del producto completando auditorías de producto, empresa, sistema, cumplimiento y vigilancia; investigar quejas de clientes; colaborando con otros miembros de la gerencia para desarrollar nuevos productos y diseños de ingeniería, y métodos de fabricación y capacitación. _Maintains and improves product quality by completing product, company, system, compliance, and surveillance audits; investigating customer complaints; collaborating with other members of management to develop new product and engineering designs, and manufacturing and training methods._
- Prepara documentación e informes de calidad mediante la recopilación, el análisis y el resumen de información y tendencias, incluidos procesos fallidos, estudios de estabilidad, retiros, acciones correctivas y revalidaciones. _Prepares quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations._
- Asegure el cumplimiento general del sitio de GMP, FDA QSR e ISO 13485. _Assure overall site compliance to GMP, FDA QSR & ISO 13485._
- Actúa como responsable del servicio de aseguramiento de calidad en la validación (redacción e informe de protocolos), planificación maestra de la validación de transferencia de procesos, DOE para la mejora de procesos, inspección de calidad de recibos, pruebas e informes, diseño de pruebas, reducción de pruebas destructivas, entre otros. _Acts as responsible for servicing Quality Assurance on validation (protocol writing and reporting), master planning of process transfer validation, DOE for process improvement, incoming quality inspection, test and reports, test design, destructive test reduction, among others._
- Puede administrar el sistema de CAPA. _May manage the CAPA system._
- Desarrollar y capacitar al personal en: investigaciones de quejas, resolución de causa raíz real de CAPA, preparación de pFMEA, GMP, PIB, capacitación y entrenamiento de GLP, manejo y solución de NCMR, con un enfoque de administración de riesgos. _Develop and train personnel on: complaint investigations, CAPA real root cause fixing, pFMEA Prep., GMPs, GDPs, GLPs training and coaching, NCMR handling and solution, with a risk management approach._
- Proporciona información y asistencia para implementar y mantener la mejora y optimización del proceso concentrándose en metodologías proactivas. _Provides insight and assistance of implementing and maintaining p[ocess improvement and optimization concentrating on proactive methodologies._
- Ayuda a impulsar la estandarización de los procesos de fabricación. _Assists in driving the standardization of manufacturing processes._
- Proporciona soporte técnico sobre problemas de calidad con el cliente según sea necesario. _Provides technical support on quality issues with the customer as needed._
- Responsable de desarrollar y determinar la viabilidad y las técnicas para la int

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