Sr. Eng, Project Quality

hace 2 semanas


Tijuana, Baja California, México BAXTER A tiempo completo

Vantive:
A New Company Built On Our Legacy

Baxter is on a journey to spin off our ~$5B Kidney Care segment into a standalone company.

Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.


At Vantive, you will become part of a community of people who are focused, courageous and don't settle for the mediocre.

Each of us are driven to help improve patients' lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

Objetivo principal del puesto:


Responsable de analizar las especificaciones y atributos críticos de calidad durante actividades de introducción de nuevos productos y durante la ejecución de planes de corrección y mejora a procesos con el propósito de asegurar la calidad del producto de acuerdo a los estándares de Calidad de Baxter así como también fortalecer el mejoramiento continuo en los procesos de manufactura de planta.


Principales Actividades y Responsabilidades:

  • Analizar todas las especificaciones de nuevos productos.
  • Desarrollar Plan de Control de calidad y métodos de aceptación para todos los productos en planta.
  • Coordinar la realización e implantación de actividades de manejo de riesgo al producto.
  • Asegurar que los nuevos procesos, equipos, métodos de prueba y planes de muestreo y aceptación permiten cumplir con la calidad requerida.
  • Detectar y documentar desviaciones en los productos durante la fase de implementación y validación.
  • Realizar toda la documentación de calidad necesaria para el proceso de manufactura (SOP, instrucciones, Poka Yoke, manejo de muestras, etc).
  • Seguimiento de R&R internas.
  • Colabora con los ingenieros de manufactura y proyectos durante validación y verificación de nuevos procesos y equipos.
  • Coordinar equipos multidisciplinarios durante la planeación y ejecución de cambios, mejoras e implementaciones de nuevos procesos, métodos y tecnologías.
  • Dar soporte a líderes de proyecto en todas las actividades del ciclo de vida de validación.
  • Análisis estadístico de la variación de los procesos, control de procesos/productos.
  • Dar cumplimiento a GAMP 5, Annex 11 EC, CFR 21 parte 11 y estándares internacionales enfocados a la validación de sistemas computacionales y aplicación de integridad de datos
  • Asegurar la calificación y operación de las áreas controladas dentro de las especificaciones ambientales aplicables.
  • Formar parte de la estructura en la toma de decisiones concernientes al cumplimiento regulatorio y de estándares de calidad en todas las operaciones antes descritas.
  • Cumplir con los sistemas de Seguridad e Higiene, ISO Gestión Ambiental) y de acuerdo a la NOM041, así como los que apliquen.
  • Aplicar y seguir los lineamientos de EHS de acuerdo a los procedimientos establecidos, estándares y normas oficiales mexicanas.
  • Usar el equipo de protección personal (EPP) asignado de acuerdo a la NOM01
  • Apoya el cumplimiento del Sistema de Calidad mediante su participación en investigaciones como dueño asegurando que las actividades relacionadas al seguimiento de un NCR/CAPA son ejecutadas, completadas y documentadas correctamente.

Escolaridad:

Nível licenciatura en las áreas de Ingeniero Industrial, Ingeniero mecanico, Químico Industrial, Ingeniero Químico o disciplinas similares.

Experiência:

  • 5 años de experiência en Proyectos, calidad de operaciones o validaciones.
  • 5 años de experiência mínima en procesos de manufactura y ensamble de dispositivos médicos.
  • 5 años de experiência mínima en procesos de aseguramiento de calidad, generación de instrucciones de trabajo, controles de cambio, acciones correctivas o preventivas, auditorías internas

Conocimientos:

  • Dominio de inglés avanzado.
  • Conocimiento de métodos estadísticos para control de proceso y generación de planes de muestreo para aceptación de pruebas de calidad
  • Conocimiento en instrumentos de medicion (Vernier, Micrometro, Smart Scope, etc) y generacion de rutinas de medicion.
  • Deseable conocimiento en diseño de experimentos
  • Conocimiento en la validación de procesos, calificación de equipos y validación de métodos de prueba.
  • Conocimiento en el manejo de estadística, metodología Six Sigma y manejo de evaluación de riesgo.
  • Sistemas ERPs: SAP, TcU, JDEdwards.
  • MDSAP. (Medical Device Single Audit Program)
  • ISO13485

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.

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