Quality Assurance Specialist
hace 2 días
¿Estás listo para unirte a nuestra fuerza laboral en Viant Medical?
Descripción del trabajoNuestro equipo busca a un Associate de Manufactura Regulada que se encargue de apoyar a nuestros ingenieros en las actividades relacionadas con los proyectos, como la preparación y traducción de documentos, la especificación de componentes e item master, la validación y ejecución de protocolos TMV, así como la representación de la calidad en el proceso de producción.
Entre tus responsabilidades se incluyen:
- Representar a la calidad en el proceso de producción y apoyar al equipo en la elaboración de FMEA y análisis de riesgos.
- Ayudar en la creación de pruebas de metrología de calidad.
- Coleccionar datos de procesos para asistir en la transferencia, capacitación y validación de trabajos de proyecto bajo la guía de un Ingeniero de Calidad.
- Ejecutar inventarios cuando sea necesario (Cajas de Calidad).
- Crear Especificaciones de Componente e Item Master.
- Ejecutar Inspecciones de Artículos Iniciales.
- Iniciar NC y Quejas cuando sea necesario.
Se requiere:
- Estudios en carreras técnicas o científicas (como Farmacia, Microbiología, Física y Química).
- Conocimientos intermedios del paquete de Microsoft Office (Word, Excel, PowerPoint y Outlook).
- Conocimiento sobre ISO 13485:2016 y CFR 820 CGMPs.
- Un año de experiencia en Viant o tres años en un entorno de manufactura altamente regulado (dispositivos médicos) con posiciones de creciente responsabilidad.
Para este puesto se requiere:
- Tener al menos un año en el cargo actual.
- No haber tenido acciones disciplinarias de menos de tres meses.
Nuestra remuneración estimada es entre $45.000 y $60.000 al año, dependiendo de tu experiencia y habilidades.
Nuestro salario es competitivo y ofrecemos beneficios exclusivos para garantizar tu bienestar y éxito profesional.
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