Quality Engineer II

hace 6 días

Tecate, Baja California, México Formula Plastics Inc A tiempo completo

Descripción de la empresa
Formula Plastics es un socio de confianza para empresas innovadoras, especializado en soluciones plásticas de alta calidad en industrias altamente reguladas, con el propósito de impactar positivamente en la vida de las personas. Somos reconocidos por nuestro compromiso con la excelencia y formamos parte orgullosa de la familia de empresas Arterex ).

Descripción del puesto
Como Ingeniero/a de Calidad II en Formula Plastics, serás responsable de garantizar que nuestros productos cumplan con los estándares de calidad exigidos. Entre tus tareas diarias se incluirá el monitoreo y control de calidad durante todo el ciclo de producción, la implementación de procesos de mejora continua y el análisis de datos para desarrollar soluciones efectivas. Este es un puesto de tiempo completo que se realizará de manera presencial en nuestras instalaciones ubicadas en Tecate, BCN.

Requerimientos mínimos:

  • Licenciatura en ingeniería o en el campo de la salud.
  • Comunicación conversacional en inglés (Medio-Avanzado).
  • 2 años de experiencia en productos sanitarios (ISO 13485:2016 y CFR Parte 820).
  • Auditor Interno Certificado ISO 13485:2016.
  • Certificado en GDTs.
  • Ingeniero de Calidad Certificado.
  • Certificación Power BI

Responsabilidades:

  • Actuar como Experto en la Materia (SME) de las actividades definidas.
  • Responsable de las actividades de Aseguramiento de la Calidad para clientes o áreas definidas.
  • Mejorar las actividades de Aseguramiento y Control de Calidad.
  • Realizar análisis de causa raíz y utilizar herramientas estadísticas para resolver problemas de calidad (internos,
  • externos o de terceros).
  • Realizar auditorías internas y externas.
  • Liderar proyectos de mejora del Control de Calidad.
  • Capacitar a los empleados en iniciativas de calidad, regulatorias y proyectos de mejora.
  • Transfiera la voz del cliente (VOC) a otros departamentos para satisfacer las necesidades y requisitos del cliente.
  • Colaborar y asociarse con las partes interesadas internas y externas, proveedores, clientes y partes interesadas.
  • Cualquier otra tarea de calidad asignada por reporte directo y asociada con la necesidad del negocio

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