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Con más de 2.100 empleados en todo el mundo, atendiendo a millones de usuarios en más de 100 países, CorDx ofrece soluciones de dispositivos médicos para pruebas rápidas y diagnóstico en el punto de atención utilizadas en la detección de enfermedades infecciosas como la COVID-19, embarazo, drogas de abuso, biomarcadores y más. CorDx se encuentra a la vanguardia de la tecnología, la inteligencia artificial y la ciencia de datos con el objetivo de ofrecer soluciones diagnósticas para algunas de las preguntas más críticas en el ámbito de la salud.   \r\n \r\nPuesto: Gerente Senior de QA \r\nUbicación: Atlanta, GA   \r\nTipo de puesto: Puesto exento presencial 5 días a la semana \r\n\r\n Gestionar y supervisar las actividades diarias del equipo de QA, asegurando la ejecución oportuna y eficaz de los procesos de calidad. \r\n Apoyar la implementación y mantenimiento del sistema de gestión de calidad (QMS) de la empresa, asegurando el cumplimiento continuo con la FDA 21 CFR Parte 820, ISO 13485 y otros estándares relevantes. \r\n Colaborar con los equipos de I+D, fabricación, asuntos regulatorios y operaciones para integrar los requisitos de calidad en el desarrollo de productos, fabricación y procesos de soporte. \r\n Liderar y apoyar auditorías internas y externas, auditorías de proveedores y revisiones de la dirección, incluyendo la preparación de la documentación requerida y acciones de seguimiento. \r\n Supervisar la gestión de no conformidades (NCR), acciones correctivas y preventivas (CAPA), quejas y desviaciones, asegurando investigaciones oportunas, análisis de causas raíz y acciones correctivas y preventivas efectivas. \r\n Asistir en la preparación para inspecciones regulatorias y auditorías de terceros, actuando como miembro clave del equipo de respuesta a auditorías. \r\n Monitorear e interpretar cambios regulatorios relevantes y tendencias de la industria, asesorando a la gerencia sobre actualizaciones necesarias en los sistemas y procesos de calidad. \r\n Desarrollar y rastrear métricas de calidad (KPI) para monitorear la efectividad del programa de QA e identificar oportunidades de mejora. \r\n Proporcionar formación y mentoría al personal de QA, fomentando una cultura de mejora continua y cumplimiento. \r\n Apoyar actividades de gestión de riesgos, incluyendo evaluaciones de riesgo y planificación de mitigación.\r\n Requisitos\r\nEducación:\r\n Título universitario en una disciplina científica, de ingeniería o técnica relacionada, obligatorio.\r\n Título de maestría o certificaciones avanzadas preferidas.\r\n Experiencia Profesional:\r\n Mínimo 7 años de experiencia progresiva en QA dentro de la industria de dispositivos médicos, IVD o ciencias de la vida reguladas.\r\n Un mínimo de 3 años en un cargo directivo o de gestión de QA.\r\n Experiencia práctica en supervisión de fabricación y calidad de productos en un entorno regulado.\r\n Conocimientos Regulatorios:\r\n Conocimiento práctico de la FDA 21 CFR Parte 820, ISO 13485 y otros estándares internacionales de calidad aplicables.\r\n Experiencia apoyando auditorías regulatorias, inspecciones de productos y presentaciones (se prefiere experiencia liderándolas).\r\n Liderazgo y Colaboración:\r\n Demostrada capacidad para supervisar y orientar al personal de QA, gestionar prioridades y colaborar eficazmente en un entorno multifuncional.\r\n Excelentes habilidades interpersonales y de comunicación.\r\n Habilidades Técnicas y Analíticas:\r\n Dominio de metodologías de resolución de problemas, análisis de causas raíz y herramientas de mejora de la calidad.\r\n Experiencia con software de sistemas de gestión de calidad (QMS) y sistemas de documentación es un plus.\r\n Certificaciones:\r\n Certificaciones ASQ (como CQE, CQA o CMQ/OE) preferidas.\r\nAtributos Preferidos:\r\n Fuertes habilidades organizativas y de gestión del tiempo, con capacidad para gestionar múltiples proyectos y plazos.\r\n Capacidad para promover y mantener una cultura de conciencia de calidad, cumplimiento y mejora continua.\r\n Beneficios\r\n Paquete salarial altamente competitivo.\r\n Seguro médico, dental y de visión integral.\r\n Plan 401(k) con contribuciones generosas de la empresa.\r\n Política flexible de tiempo libre remunerado (PTO).\r\n Beneficios adicionales sustanciales.\r\n \r\nDeclaración de Igualdad de Oportunidades: Somos un empleador que ofrece igualdad de oportunidades comprometido con la inclusión y la diversidad. 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Aunque se prevé una permanencia a largo plazo, este puesto está sujeto a restricciones presupuestarias anuales. El contrato inicial es hasta el final del presente año fiscal y se espera que se renueve a partir del 1 de julio.\n\nFunciones/Responsabilidades:\n•\tExperiencia en pruebas de aplicaciones personalizadas.\n•\tExperiencia en pruebas de componentes GIS.\n•\tInteracción activa con diversos equipos.\n•\tCrear y documentar planes de prueba, escenarios de prueba, casos de prueba, ejecutar pruebas, analizar resultados y reportar problemas e incidencias, todo desde la perspectiva de los usuarios finales del negocio.\n•\tOperar con enfoque ágil para satisfacer las necesidades de pruebas.\n•\tAsegurar que los casos de prueba estén debidamente formulados y sigan los estándares de control de calidad para garantizar que las métricas funcionen correctamente.\n•\tTrabajar estrechamente y de forma colaborativa con socios del negocio, el PMO y los equipos técnicos de entrega del proveedor para comprender los requisitos del negocio.\n•\tAsegurar que las pruebas de software se realicen a tiempo y según 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