Sr Quality Engineer

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.

RESUMEN - JOB SUMMARY:
Respaldar la implementación y el mantenimiento de los sistemas de calidad a nível de las instalaciones que cumplan con las políticas y procedimientos corporativos, las regulaciones gubernamentales y los estándares internacionales. Apoyar la implementación del diseño de nuevos productos y procesos de fabricación relacionados.

To support the implementation and maintenance of facility level quality systems which are in full compliance with corporate policies and procedures, government regulations, and international standards. To support the design implementation of new products and related manufacturing processes.

ACTIVIDADES PRINCIPALES Y RESPONSABILIDADES - ESSENTIAL DUTIES AND RESPONSIBILITIES:

- Asistir Q.A. Gerente en el desarrollo, documentación, implementación y mantenimiento de procedimientos, instrucciones y registros del sistema de calidad. Assist Q.A. Manager in the development, documentation, implementation, and maintenance of quality system procedures, instructions, and records.
- Puede realizar auditorías internas de rutina del sistema de calidad, auditorías de proveedores y calificaciones de proveedores en cumplimiento de los procedimientos. Informa los resultados de la auditoría a la gerencia. Can perform routine internal quality system audits, supplier audits and supplier qualifications in compliance with procedures. Reports audit findings to management.
- Puede liderar o participar con la administración organizacional y de operaciones grupales en las actividades de CAPA mediante la realización, determinación y verificación de 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 y la ISO 13485: 2016. May lead or participate with organizational and group operations’ management in CAPA activities by conducting, determining and verifying corrective actions necessary to ensure continued compliance with division policy and procedures, Federal regulations under Title 21 CFR Part 820, and ISO 13485:2016.
- Asiste a la gerencia y al personal del departamento en la implementación de técnicas estadísticas de control de calidad con el fin de mejorar la eficiencia y la eficacia operativa. Assists departmental management and personnel in the implementation of statistical quality control techniques for the purpose of improving operational efficiency and effectiveness.
- 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. Works with the appropriate department management to initiate corrective action necessary to resolve quality related problems identified as a result of the routine analysis of product performance data.
- Puede actuar como coordinador de CAPA y / o coordinador de calibración. May act as the CAPA coordinator and / or calibration coordinator.
- Participa en proyectos de CPE, y en la validación y verificación de productos y procesos de acuerdo con los procedimientos del sistema de calidad. Participates in CPE projects, and product and process validation and verification according to quality system procedures.
- Responsable de monitorear, identificar tendencias, investigar y resolver problemas presentados a través de quejas de los clientes. Responsible for monitoring, identifying tendencies, investigating and solving problems submitted through customer complaints.
- Trabaja con proveedores para mejorar la calidad de los componentes. Works with suppliers to improve component quality.
- Puede liderar o participar en transferencias de proyectos y procesos de control, estableciendo criterios de aceptación del producto, calidad y calibración. Can lead or participate in project transfers and process controls, establishing acceptance criteria of the

**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 seeker

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