Sr Mgr, Quality Operations

hace 3 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.

1. Direct responsibility for ensuring full regulatory compliance and product and process controls.
2. Direct responsibility for ensuring, managing, controlling and limiting non-compliant events associated with the products and processes installed in the plant.
3. Direct responsibility for supporting CAPAs associated with areas of responsibility.
4. Direct responsibility for ensuring that product/process changes made do not result in product mix-ups or configuration errors.
5. Generate and execute approved plans for the correction/prevention of component scrap, process variation and rework.
6. Generate and execute approved plans for the correction/prevention and improvement of plant productivity.
7. Generate and execute approved plans for the correction/prevention of internal non-conforming events.
8. Generate and execute approved plans for the correction/prevention of recall actions in the marketplace.
9. Direct responsibility for plant-wide product release.
10. Direct responsibility for resolution of non-conforming events due to interaction/interface of different internal processes.
11. Communication and joint work with Quality Engineering in charge of suppliers.
12. Communication and joint work with Quality Engineer in charge of customer complaint handling.
13. Direct responsibility in the reduction of process variation in the plant.
14. Participation in CAPA with direct responsibility and team participation.
15. Direct responsibility for completing improvements within the Quality System through the Change Control System.
16. Direct responsibility for staff training and technical improvement.
17. Direct responsibility for clean room performance in compliance with ISO8 classification.
18. Responsible for verifying the proper use of personal protective equipment in the area.
19. Applies and follows EHS guidelines in accordance with established procedures, standards and official Mexican norms.
20. Supports Quality System compliance by monitoring, following up and supporting the company's Corrective and Preventive Action System; also participating as part of the CAPA System Review Board (CRB) Committee.

Escolaridad:
Título de Ingeniería como Química, Biológica, Mecánica, Electrónica, Electromecánica, Industrial o carrera a fin.
Experiência:
Experiência mínima de 2 años en la industria medica con responsabilidad gerencial.
Experiência con las siguientes regulaciones de FDA:

- 21CFR820
- 21CFR803
- 21CFR7
- 21CFR11
- 21CFR806

Calificaciones: Para realizar este trabajo exitosamente, el individuo debe ser capaz de realizar cada tarea esencial satisfactoriamente. Liste los conocimientos, habilidades y/o competencias requeridas. N/A: Pasante o Practicante
Conocimientos:

- Dominio Inglés avanzado
- Conocimiento práctico aplicado en sistemas de calidad de productos médicos, preferentemente operaciones de Calidad (Control de Calidad) dentro de un ambiente de manufactura. Empero, Ingeniería de Calidad o Cumplimiento Regulatorio es aceptable.
- Conocimiento práctico aplicado de metodología estadística para la mejora de calidad de productos y procesos, incluyendo diseño experimental, correlación, análisis de capacidad y regresiones lineales, análisis de Pareto de causa y efecto.
- Para el cumplimiento de las metas de la posición, se requiere habilidad en comunicar información técnica efectivamente, escrita y verbal.
- Tener el conocimiento práctico aplicado de las prácticas de buena manufactura asociada con la FDA y otros elementos regulatorios de la FDA, también, conocimiento de ISO13485, MDD de acuerdo con el 93/42/ECC y algunos estándares internaciones de producto como ASTMs, BSI, ANSI, como apliquen.

Competencias:

- Actúa con rapidez orientado a la acción y la obtención de resultados.
- Procede con simplicidad, optimizando el trabajo y generando adaptabilidad situacional.
- Interviene con valentía interactuando con la ambigüedad y cultivando la innovación.
- Genera colaboración valorando las diferencias y promoviendo el compromiso.
- Actúa con rapidez orientado a la acción y la obtención de resultados.
- Procede con simplicidad, optimizando el trabajo y generando adaptabilidad situacional.
- Interviene con valentía interactuando con la

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