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Lead Quality Specialist

hace 2 semanas

San Vicente Ferrer, Colombia GE Healthcare A tiempo completo
**Job Description Summary**: GE HealthCare es un innovador líder mundial en tecnología médica y soluciones digitales con más de 100 años de experiência en la industria de la salud y alrededor de 50.000 empleados en todo el mundo.
Permitimos a los médicos tomar decisiones más rápidas e informadas a través de dispositivos inteligentes, análisis de datos, aplicaciones y servicios, respaldados por nuestra plataforma de inteligencia Edison. Operamos en el centro de un ecosistema que trabaja hacia la precisión de la digitalización de la salud, ayudando a impulsar la productividad y mejorando los resultados para pacientes, proveedores, sistemas de salud e investigadores de todo el mundo.
Liderarás el área de Aseguramiento de Calidad en Colombia y Perú en todos los aspectos que involucran el Sistema de Calidad de la compañía, asegurando el cumplimiento de los requisitos internos y externos de la industria de dispositivos médicos.
**Lo que harás**:
- ** Garantizar cumplimiento de requisitos de la Resolución 4002, asegurando el mantenimiento de la certificación CCAA**:
- ** Mantener relaciones sólidas y efectivas con la autoridad reguladora local y representar a GEHC ante las partes interesadas clave.**:
- ** Mantener los procedimientos locales actualizados, en cumplimiento del sistema de calidad.**:
- ** Trabajar con la operación para garantizar que se proporcionen aportes apropiados y oportunos, delante de investigaciones, desvíos y CAPAs.**:
- ** Soportar las actividades locales siendo apoyo al equipo asuntos regulatorios y apoyo a comerciales locales en temas estratégicos y operativos.**:
- ** Asegurar el cumplimiento del sistema de gestión de calidad en general.**:
**Lo que necesitas tener**:
- ** Título Universitario en Farmacia o áreas relacionadas a la ciencia.**:
- ** De 3 a 5 años de experiência en aseguramiento de calidad en la industria de dispositivos médicos, incluyendo conocimiento y experiência con leyes y regulaciones de dispositivos médicos (INVIMA). La experiência con otros países de América Latina es deseable pero no obligatoria.**:
- ** Experiência en auditorias y en la ISO 13485.**:
- ** Experiência en manejo del sistema de calidad.**:
- ** Experiência en proceso de CAPAs, mejora continua, manejo de proyectos.**:
- ** Experiência en posiciones de liderazgo.**:
**Sería bueno que tuvieras**:
- ** Fuertes habilidades analíticas.**:
- ** Capacidad para trabajar sin supervisión en proyectos y actividades y en equipos multifuncionales.**:
- ** Capacidad para priorizar, planificar y evaluar los entregables.**:
- ** Enfoque en la ejecución de proyectos, tareas llegando a los resultados esperados.**:
- ** Excelentes habilidades de comunicación y presentación verbal y escrita con la capacidad de comunicarse en inglés de una manera fácil de entender.**:
- ** Disponibilidad para trabajar 100% presencial en la oficina o warehouse.**:
GE Healthcare es un Empleador de Oportunidades Iguales donde la inclusión es esencial. Esto significa que todas las decisiones se toman independientemente de la raza, el color, la religión, el origen nacional o étnico, el sexo, la orientación sexual, la identidad o expresión de género, la edad, la discapacidad u otras características protegidas por la ley.
Esperamos que todos los empleados vivan y respiren nuestros comportamientos: actuar con humildad y generar confianza; liderar con transparencia; entregue con enfoque e tener dominio de sus actividades, siempre con una integridad inquebrantable.
Nuestras recompensas totales están diseñadas para desbloquear su ambición al brindarle el impulso y la flexibilidad que necesita para convertir sus ideas en realidades que cambian el mundo. Nuestro salario y beneficios son todo lo que esperaría de una organización con fuerza y escala global, y estará rodeado de oportunidades profesionales en una cultura que fomenta el cuidado, la colaboración y el apoyo.
LI-AG3
**Additional Information**:
**Relocation Assistance Provided**:No