Sr Eng, Supplier Quality

hace 1 semana


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.

**Objetivo principal del puesto**:
Ingeniería de Calidad asociado con la mejora de productos y procesos usando todas las herramientas y datos del sistema de calidad. Reducción de la variación de los procesos, control de procesos/productos, análisis de riesgo de las familias de producto de la planta, implementación de acciones de mejora resultante del análisis de datos de la experiência del producto interna y externa.

**Principales Actividades y Responsabilidades**:
Apoya con actividades el desarrollo y la implementación de los sistemas de calidad de la planta asociado con actividades de control de procesos/productos. Asegura la ejecución de los sistemas y procedimientos en cumplimento de la regulación para sus áreas de responsabilidad. Cooperación periódica en la revisión de la efectividad del sistema de calidad.

Apoyo directo en las inspecciones regulatorias.

Esta es una posición de Ingeniería de Calidad con actividades de a seguranza de calidad para promover el complimiento continuo del ISO13485 y de las regulaciones de la FDA (todas) pero con especial atención al 21CFR820.22, 30, 65, 70, 75, 90, 100, 130, 184, and 198. La posición tiene la responsabilidad de mantener el cumplimiento regulatorio de la planta de los elementos listados arriba. ISO

1. Es responsable de los resultados específicos en términos de la calidad del producto y el cumplimiento de las regulaciones y de las políticas de Baxter para la reducción de la variación del proceso/producto, mejora/implementación de los controles de proceso/productos, análisis de riesgo de productos/procesos asignados, así como también de la aprobación de nuevos proveedores dando seguimiento a la creación y alta de sus registros en el sistema de calidad Baxter, realiza las reevaluaciones de proveedores en tiempo. Todo lo anterior usando como datos la experiência interna/externa del producto. GQR-11

2. Da seguimiento a las notificaciones de cambio de proveedores. GQP-11-03

3. Gestiona la baja de los proveedores y materiales que ya no son requeridos en los procesos de Baxter. GQP-11-03

4. Apoya y mantiene la comunicación sobre las acciones que se implementen para mitigar los riesgos debidos a fallas de los proveedores GQP-11-05 / 300905-103

5. Mantiene actualizado el listado de proveedores aprobados. GQP-11-01 para calificar y aprobar

6. Gestiona y da apoyo para los proyectos de mejora en el alta y aprobación de proveedores.

7. Evalúa el desempeño de los proveedores consolidando a los procesos de compras y planeación. GQP-11-05 Y GQP-11-04

8. Evalúa los requisitos para aprobar o rechazar nuevos proveedores. GQP-11

**Educación y/o Experiência**:
3 a 5 años de experiência en Calidad (Deseable industria Medica), Manufactura.

**Escolaridad**:
Nível licenciatura en las áreas de QFB, QBP, Ing. Químico, Químico Industrial o disciplinas similares.

**Experiência**:
De 3 a 5 años de experiência en Calidad (Deseable industria Medica), Manufactura.

**Conocimientos**:

- RAB, CQE, CQA, CQM.
- Bilingüe español-inglés.
- Control de cambios en ambiente regulado.
- ISO11137, ISO13485, ISO14664.
- 21CFR part 820, 3, 5, 11, 210/211.
- ERP.
- Experiência en el desarrollo y ejecución para atender una auditoria de FDA Auditoria
- Resolución de problemas, CAPA, DMAIC,
- Moldeo, extrusión (deseable) ensamble manual y automatizado de dispositivos médicos
- MDSAP. (Medical Device Single Audit Program)

**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.

108586



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