Quality Engineer Ii

hace 2 semanas


Juárez, Chihuahua, México Johnson & Johnson A tiempo completo
At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities, and forward progress.

That's why for more than 135 years, we have aimed to keep people well at every age and every stage of life.

Today, as the world's largest and most broadly based healthcare company, we are committed to using our reach and size for good.

We strive to improve access and affordability, create healthier communities, and put a healthy mind, body, and environment within reach of everyone, everywhere.

Every day, our more than 140,000 employees across the world are blending heart, science, and ingenuity to profoundly change the trajectory of health for humanity.


Diversity, Equity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years.

Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world.

When You Join Johnson & Johnson, Your Move Could Mean Our Next Breakthrough.


At Johnson & Johnson MedTech, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible.

For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health.

In surgery, orthopedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalized.


We are searching for the best talent for QUALITY ENGINEER II to be in CIUDAD JUAREZ.

Purpose:


Bajo supervisión general, participe en equipos de productos / procesos nuevos y sostenibles para desarrollar sistemas y productos de ingeniería de calidad, liderar y respaldar pruebas de verificación de diseño, validaciones de procesos, procesos de calidad para garantizar el cumplimiento de las políticas y procedimientos del Sistema de Calidad de la compañía y los requisitos y estándares externos aplicables, incluidos FDA, ISO 13485, CMDCAS, PMDA y otras agencias reguladoras mundiales, Johnson & Johnson Ambiental, Prácticas de salud y seguridad, y otras normas aplicables en lo que respecta a los dispositivos médicos.

Apoya las actividades de garantía de calidad destinadas a garantizar que los procesos de calidad de productos efectivos estén en su lugar y se ejecuten durante todo el ciclo de vida del producto.

Recibirá orientación técnica sobre problemas complejos, pero de forma independiente desarrolla enfoques y soluciones. El trabajo generalmente está bien definido y se verifica el progreso y se revisa la precisión al finalizarl.

You will be responsible for:

Bajo dirección general y de acuerdo con todas las leyes / regulaciones federales, estatales y locales aplicables y Corporativas Johnson & Johnson, procedimientos y pautas, esta posición:

  • Las responsabilidades principales incluyen la asistencia en un papel de apoyo en el desarrollo de nuevos productos, el mantenimiento y los proyectos de calidad de la cadena de suministro. Ayudar en el desarrollo de un control de calidad efectivo y planes de gestión de riesgos asociados.
  • Escribir protocolos e informes de validación de procesos y productos, calificaciones de equipos, órdenes de cambio de ingeniería.
  • Utilice herramientas estadísticas para analizar datos, tomar decisiones de aceptación y mejorar la capacidad del proceso (Six Sigma, SPC, DOE).
  • Ayudar a garantizar que las actividades de desarrollo sigan los requisitos de control de diseño, que el producto se pruebe según las normas aplicables, que los requisitos esenciales europeos se cumplan según el MDR y que el producto se transfiera correctamente a la fabricación.
  • Proporcionar soporte en oportunidades de mejora de la calidad según corresponda a los productos heredados, mejora continua y satisfacción del cliente
  • Ayudar en la planificación necesaria para garantizar la aceptación efectiva del producto. Esto incluye, pero no se limita a, instrucciones de inspección, requisitos de equipo y medidor, y planes de muestreo.
  • Apoye las auditorías de proveedores como líder técnico según sea necesario y respalde la calidad del proveedor como representante de calidad de franquicia según corresponda.
  • Apoye las actividades de NC, CAPA, Auditoría Interna, Capacitación y QS según sea necesario y garantice el cumplimiento de todas las fechas de vencimiento aplicables.
  • Iniciar e investigar Acciones Correctivas y Preventivas (CAPA) según corresponda.
  • Ayudar en el análisis de quejas según corresponda.
  • Ayudar a Asuntos Regulatorios en el desarrollo de presentaciones para cambios de procesos, cambios de inspección y nuevos procesos / dispositivos según sea necesario.
  • Se requiere un eje

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