Senior Quality Engineer

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 SENIOR QUALITY ENGINEER to be in CIUDAD JUAREZ.

Purpose:


Participar en nuevos equipos de productos / procesos 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, Prácticas de Johnson & Johnson Ambientales, de Salud & Seguridad, y otras normas aplicables en lo que respecta a los productos sanitarios.

Impulse 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.

Puede recibir orientación técnica sobre problemas complejos, pero determina y desarrolla de forma independiente enfoques y soluciones. Comparte experiência técnica con otros y ayuda a desarrollar ingenieros de nível junior.

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 trabajar en Ingeniería de Calidad y con otros grupos funcionales en apoyo del desarrollo de nuevos productos / procesos, operaciones de calidad o aseguranza de calidad.
  • Utilizar herramientas / procesos de ingeniería de calidad en el desarrollo e implementación de prácticas para el desarrollo, transferencia y mantenimiento efectivos y eficientes de productos / procesos a lo largo del ciclo de vida del producto.
  • Liderar esfuerzos con oportunidades de mejora de la calidad según corresponda a los productos heredados, mejora continua y satisfacción del cliente.
  • Desarrollar y establecer un control de calidad efectivo y apoyar los planes de gestión de riesgos asociados.
  • Redactar, revisar y/o aprobar 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).
  • Determinar los requisitos de esterilidad, biológicos y de pruebas de empaque utilizando los estándares apropiados de la industria o la agencia para nuevos productos.
  • Asegúrese de que las actividades de desarrollo sigan los requisitos de control de diseño, que el producto se pruebe según las normas aplicables, que se cumplan los requisitos esenciales europeos según el MDR y que el producto se transfiera correctamente a la fabricación.
  • Proporcionar toda la planificación necesaria para garantizar la aceptación efectiva del producto. Esto incluye, pero no se limita a, las calificaciones de las piezas, el desarrollo de especificaciones y los planes de muestreo.
  • Apoye las auditorías de proveedores como líder técnico según sea necesario y respalde la calidad del proveedor como representante de Calidad según corresponda.
  • Iniciar e investigar Acciones Correctivas y Preventivas (CAP

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