Quality Control Operator

5 days ago

Castle Hill, Australia CooperCompanies Full time

Inspección del producto de acuerdo con las especificaciones y requerimientos de calidad establecidos requeridos por la organización y procesamiento del mismo post-esterilización final. Responsable por el despacho (reléase) de Producto Final establecido por los estándares y la regulación.

DEBERES Y RESPONSABILIDADES PRINCIPALES: 

Inspeccionar el producto esterilizado conforme a las especificaciones y procedimientos de calidad establecidos. Ejecutar pruebas dirigidas a verificar la calidad del producto final de acuerdo con los procedimientos vigentes y utilizando los equipos de prueba correspondientes. Verificar la documentación del producto final y asegurarse que cumpla con los requerimientos de acuerdo a los procedimientos establecidos. Ejecutar la disposición final del producto utilizando los sistemas establecidos para la aprobación. Tomar disposición (aprobar, rechazar), “Parametric Release”, de los ciclos de esterilización. Tomar disposición (aprobar, rechazar) los “Inserts” a ser utilizados en la manufactura de lentes de contacto. Mantener un ambiente de trabajo positivo y una relación de respeto, armonía y trabajo en equipo con sus compañeros. Realizar tareas en diferentes áreas. Podrá ser asignado a una o más tareas y rotará de acuerdo a las necesidades del negocio. Llevar a cabo la verificación de calibración a equipos de pruebas de calidad (Vertex, Optimec) y mantener los

registros de estos en cumplimiento regulatorio

Aprobar “Inserts” de acuerdo a procedimiento establecido. Ejecutar y verificar la calibración de equipos de medición necesarios para algunas tareas como por ejemplo PH meters Documentar resultados de auditoría de dimensionales en el sistema de Infinity QS. Reportar muestreos realizados durante la inspección del producto en el sistema de BPCS. Cumplir con los procedimientos y políticas establecidos en Cooper Vision. Someter mejoras a los procedimientos establecidos para las auditorías y aprobación del producto. Monitorear el proceso de certificación de asociados nuevos en esta posición. Coordinar con los líderes de QAF la evaluación de los lotes no conformes.

Funciones No Ensenciales:

Realizar y/o coordinar algunos trabajos como parte de proyectos especiales y/o roles temporeros. Proveer apoyo durante la ejecución de pruebas especiales. Auditar cumplimiento de procedimientos durante el proceso de QA y Manufactura. Organizar y archivar la documentación de lotes y ciclos de esterilización. Segregar e identificar el producto rechazado a la Jaula de Cuarentena. Preparar y realizar el archivo de la documentación. Mantener el control de documentos provistos a otros departamentos/áreas. Proveer apoyo en la búsqueda y/o archivo de documentos concernientes a visitas de FDA u auditorias. Proveer información y/o reportes a los “Process y Quality Improvers” la documentación de los lotes no conformes.

EDUCACION:

Grado asociado o experiencia equivalente, preferible. 

 REQUISITOS DE LA POSICION:

Experiencia en inspección de dispositivos médicos bajo un Sistema de Control de Calidad, preferible.

Experiencia en operación de equipo automatizado, preferible.

Conocimiento básico en el uso de computadoras.

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