Quality Assurance Engineer

2 weeks ago


Utica, New York, United States CONMED Corporation Full time


El Ingeniero de Calidad de Proveedores II es fundamental para supervisar la calidad de los productos suministrados por proveedores y contratistas a CONMED, asegurando el cumplimiento de las normativas mediante el seguimiento de controles de compra adecuados. Esto incluye procedimientos para la calificación de proveedores, calificación de partes, gestión de no conformidades, acciones correctivas de proveedores y monitoreo del rendimiento de los proveedores.

Este rol apoya la adquisición de artículos comprados a través de una evaluación de las capacidades del proveedor y la finalización exitosa de las calificaciones de componentes que verifican las capacidades de fabricación.

Durante las actividades de desarrollo de nuevos productos, el Ingeniero de Calidad de Proveedores II proporciona orientación sobre métodos de inspección y colabora estrechamente con los servicios de Inspección para llevar a cabo Análisis de Sistemas de Medición (MSA) y establecer correlaciones con el proveedor.

Además, trabaja en conjunto con compras, manufactura y el proveedor para facilitar la resolución de problemas relacionados con no conformidades y garantizar que se implementen acciones correctivas efectivas para prevenir recurrencias.

Responsabilidades:

  • Apoya la resolución de problemas para artículos comprados y proporciona evaluación de riesgos y disposición final de productos no conformes.
  • Colabora en el desarrollo de nuevos productos comprados, incluyendo requisitos de especificación y documentación de riesgos.
  • Facilita y aprueba las calificaciones de componentes de proveedores, incluyendo validaciones de procesos, para verificar la implementación de técnicas de inspección aceptables, controles de procesos de fabricación y controles del Sistema de Calidad.
  • Trabaja con el proveedor y la inspección de recepción para desarrollar y correlacionar métodos de inspección robustos y fijaciones según sea necesario.
  • Crea y actualiza Planes de Inspección de Recepción.
  • Apoya Solicitudes de Cambio de Proveedor y facilita la evaluación de impacto y el desarrollo de planes.
  • Solicita y verifica la finalización exitosa de Inspecciones de Primer Artículo durante las calificaciones de partes.
  • Gestiona/conduce auditorías a proveedores (en sitio o a distancia) y verifica la finalización de acciones correctivas identificadas (SCARs).
  • Mantiene registros para la coordinación de informes del Sistema de Calidad.
  • Identifica e implementa oportunidades de mejora en los procesos del Sistema de Calidad.

Requisitos:

  • Título universitario.
  • Más de 2 años de experiencia profesional.

Conocimientos Preferidos:

  • Conocimiento de los Requisitos del Sistema de Calidad de dispositivos médicos y comprensión del cumplimiento con FDA CFR 21 parte 820, GMP e ISO 13485.
  • Certificaciones ASQ (CQA, CQE).
  • Capacidad para leer y comprender dibujos de ingeniería. Comprensión de especificaciones GD&T y su traducción a métodos de medición.
  • Capacidad para implementar métodos y técnicas estadísticas para controles de procesos y análisis de datos.
  • Comprensión de la aplicación práctica y capacidades de varios tipos de equipos de inspección, incluyendo herramientas manuales (calibradores fijos, micrómetros, calibradores) y sistemas programables de toque y visión (CMM, DVM) y equipos similares.
  • Experiencia y/o capacitación en técnicas de resolución de problemas DMAIC.
  • Comprensión de varios procesos de fabricación, incluyendo mecanizado, moldeo, conformado, recubrimientos y varios tratamientos de superficie.

Expectativas de Viaje: 0-20%




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