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.

**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.
- 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.
- 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.
- 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.
- 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.
- Puede actuar como coordinador de CAPA y / o coordinador de calibración.
- Participa en proyectos de CPE, y en la validación y verificación de productos y procesos de acuerdo con los procedimientos del sistema de calidad.
- Responsable de monitorear, identificar tendencias, investigar y resolver problemas presentados a través de quejas de los clientes.
- Trabaja con proveedores para mejorar la calidad de los componentes
- Puede liderar o participar en transferencias de proyectos y procesos de control, estableciendo criterios de aceptación del producto, calidad y calibración.
- Establezca planes de inspección de entrada, calificación de componentes, planes de muestreo y criterios de componentes.
- Dirigir o participar en proyectos de Value Stream (mejoras de calidad, ahorro de costos, aumento de la productividad).
- Asegura que los deberes y responsabilidades de los subordinados estén claramente definidos y que el desempeño sea medido y revisado rutinariamente. Esto incluye:

- Definición de estándares de desempeño y objetivos relacionados.
- Establecimiento de estándares de trabajo medibles.
- Evaluar el desempeño para asegurar el logro de los objetivos individuales, departamentales y divisionales, utilizando los procedimientos de evaluación corporativa.
- Comunicar a los subordinados el desempeño real contra el estándar y los objetivos.
- Desarrollar personas clave para garantizar un funcionamiento sin problemas.

**EDUCACI**Ó**N EXPERIENCIA, CERTIFICACIONES Y HABILIDADES**

**Educación requerida**:

- Ingeniería o carrera técnica.

**Experiência deseable**:

- Educación formal o capacitación en técnicas de control de calidad, incluidas auditorías de sistemas de calidad, herramientas estadísticas, diseño de experimentos, análisis de regresión y métodos de muestreo estadístico, principios de Lean.
- 2 años o más de experiência en la operación de fabricación deseable. Experiência deseada en regulaciones y estándares de dispositivos médicos, incluidas las regulaciones de dispositivos médicos de la FDA cubiertas por el Título 21 CFR Parte 820, Directiva europea de dispositivos médicos 93/42 / CEE.

**Bilingüe**:Comunicaciones orales y escritas en inglés y español requerido.

**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 protec

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