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Miguel Alemán, Tamps., Mexico","infoId":"6433231590144312","pictureUrl":"https://uspic3.ok.com/logo/ineed.png","videos":null,"title":"Ingeniero Sénior de Calidad de Proyecto","content":"**Acerca de Convatec**\n\n**Pioneros en soluciones médicas confiables para mejorar las vidas que tocamos:** Convatec es una empresa global de productos y tecnologías médicas, centrada en soluciones para el manejo de condiciones crónicas, con posiciones líderes en Cuidado Avanzado de Heridas, Cuidado de Ostomía, Cuidado de la Incontinencia y Cuidado de Infusión. Con más de 10.000 colegas, ofrecemos nuestros productos y servicios en aproximadamente 90 países, unidos por una promesa de ser eternamente cuidadosos. Nuestras soluciones ofrecen una serie de beneficios, desde la prevención de infecciones y la protección de la piel en riesgo, hasta mejores resultados para los pacientes y una reducción en los costos de atención. Los ingresos de Convatec en 2024 fueron superiores a $2 mil millones. La empresa forma parte del índice FTSE 100 (LSE:CTEC). Para obtener más información, visite http://www.convatecgroup.com\n\n \n\n\n\nComo Ingeniero Sénior de Calidad de Proyecto, usted se encargará de asegurar que se establezca un buen entorno dentro del equipo de ingeniería de calidad.\n\nMantener al personal capacitado y motivado en las áreas bajo su responsabilidad.\n\nSer el líder principal garantizando el cumplimiento de regulaciones, normas y procedimientos internos del sistema de gestión de calidad en un nuevo proyecto (CCR).\n\nMejoras de procesos (OFI), Validación y Revalidaciones, Gestión de Riesgos e investigaciones de reclamaciones de clientes que son manejadas directamente por su equipo - Ingenieros de Calidad de Proyecto (PQE).\n \n\nAsegurar que los problemas de calidad sean adecuadamente gestionados desde una no conformidad, mantener indicadores de calidad y desviaciones internas, garantizando que las actividades se realicen de manera correcta y oportuna.\n\nPrincipales responsabilidades:\n\n\nSupervisar las actividades del personal bajo su responsabilidad.\n\n\nEvaluar los recursos necesarios para realizar las tareas en las áreas correspondientes. Identificar necesidades y realizar capacitaciones en las áreas para el personal a cargo. Desarrollar las habilidades del personal bajo su responsabilidad.\n\n\nMantener la comunicación con otras áreas en relación con problemas o mejoras de calidad (producción, mantenimiento, ingeniería, logística, proveedores, etc.). Promover ideas para mejoras continuas de Calidad con el objetivo final de lograr el cumplimiento a través de la simplicidad de los sistemas.\n\n\nSeguimiento de tendencias de NC’s/PPMs así como de VPM\n\n\nAsegurar el informe mensual de calidad\n\n\nRevisar y aprobar documentos de especificaciones de calidad. Onlines, etc.\n\n\nRelacionado con el control de procesos\n\n\nSupervisar y coordinar las investigaciones relacionadas con fallas de proceso, reclamaciones de clientes u otros problemas de calidad mediante sus recursos.\n\n\nAsegurarse de que el proceso/actividades de NC se sigan adecuadamente y según el procedimiento aplicable.\n\n\nRevisar evidencias objetivas para completar investigaciones y así garantizar el cierre correcto de NC y su efectividad.\n\n\nEmitir NC/CAPA cuando sea necesario según los procedimientos establecidos. Participar en reuniones del Comité de Revisión.\n\n\nAsegurarse de que las disposiciones finales estén bien documentadas y sigan los procedimientos adecuados.\n\n\nApoyar al sistema de calidad enfocándose en el manejo adecuado de actividades de no conformidad, acciones correctivas y preventivas.\n\n\nApoyar en definir una clasificación de todas las No Conformidades basada en el riesgo. Revisar, actualizar y desarrollar procedimientos, instrucciones y especificaciones de calidad según sea necesario.\n\n\nRealizar seguimiento al rol QA según lo requiera el procedimiento de NC (por ejemplo, Originador, Responsable, Revisor de Calidad, Aprobador, etc.) según sea necesario.\n\n\nBrindar apoyo en varias áreas donde su experiencia y conocimiento técnico sobre el problema puedan ser útiles (producción, microbiología, sistemas, etc.). Liderar y mantener la comunicación con otros departamentos MX / DK en relación con cualquier problema de calidad.\n\n\nParticipación general en proyectos como responsabilidad principal a través de los PQE asegurando que se cumplan las regulaciones u otras normas aplicables.\n\n\nApoyar en el sistema de gestión de riesgos, cuando sea necesario.\n\n\nEn cooperación con el departamento de Ingeniería, asegurar que los recursos y la planificación para las actividades de revalidación se gestionen adecuadamente.\n\n\nAsegurar que el llenado de la documentación de validación siga los procedimientos y regulaciones aplicables a través del PQE a cargo.\n\n\nApoyar en la revisión y aprobación de validaciones IQ, OQ y PQ, así como de PSE en todos los sistemas aplicados, en colaboración con el líder del proyecto.\n\n\nApoyar en la revisión y aprobación en la gestión de validaciones de software/equipos de prueba y validación de métodos.\n\n\nColaborar en la validación de moldes y máquinas de moldeo proporcionando el apoyo como Ingeniería de Calidad, cuando sea necesario.\n\n\nCumplir con la política de calidad de la empresa.\n\n\nCalificación y Educación\n\n\nTítulo universitario (Mecánica, Electrónica, Industrial o formación similar) requerido\n\n\nMínimo 3 años de experiencia en áreas de ingeniería, requerido\n\n\nInglés hablado y escrito, requerido\n\n\nExperiencia sólida en manejo de QMS (Sistema de Gestión de Calidad), requerido Experiencia sólida en gráficos de control de calidad (histograma, pareto, cálculos de capacidad de proceso, gráficos de control, etc.), requerido\n\n\nExperiencia sólida en herramientas de gestión de calidad (lluvia de ideas, diagramas de flujo, diagramas causa-efecto, etc.), requerido\n\n\nEnfoque en mentalidad de mejora continua, requerido\n\n\nCapacidad para capturar, describir y comunicar ideas al equipo de trabajo, preferido Habilidades de auditor, preferido\n\n\nExperiencia como supervisor, preferido\n\n\nCapacitación/conocimiento sobre MDSAP, MDR, FDA QSR's y GMP's, ISO 13485, J\\-PAL/Ordenanza Nº169, regulaciones de dispositivos médicos de la UE y Canadá, o regulaciones similares, preferido\n\n\nFamiliaridad con paquetes comunes de software informático. 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Si tiene dudas, contáctenos a careers@Convatec.com.\n\n**Igualdad de oportunidades**\n\nConvatec ofrece igualdad de oportunidades laborales para todos los empleados actuales y candidatos a empleo. Esta política significa que nadie será discriminado por raza, religión, credo, color, origen nacional, nacionalidad, ciudadanía, ascendencia, sexo, edad, estado civil, discapacidad física o mental, orientación afectiva o sexual, identidad de género, condición militar o de veterano, características genéticas predisponentes o cualquier otra base prohibida por ley.\n\n**Aviso a Agencias y Representantes de Firmas de Búsqueda**\n\n\nConvatec no acepta currículos no solicitados de agencias y/o firmas de búsqueda para esta publicación de empleo. Los currículos enviados a cualquier empleado de Convatec por una agencia tercera y/o firma de búsqueda sin un acuerdo de búsqueda válido por escrito y firmado, se convertirán en propiedad exclusiva de Convatec. 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