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Nuestra fortaleza en innovación sanitaria nos permite construir un mundo en el que las enfermedades complejas se prevengan, traten y curen, donde los tratamientos sean más inteligentes y menos invasivos, y las soluciones sean personalizadas. A través de nuestra experiencia en Medicina Innovadora y MedTech, estamos en una posición única para innovar en todo el espectro de soluciones sanitarias hoy en día, ofrecer los avances del mañana e impactar profundamente en la salud de la humanidad. Más información en https://www.jnj.com\n\n**Función del puesto:**\n\nCalidad**Subfunción del puesto:**\n\nCalidad Comercial/Al Cliente**Categoría del puesto:**\n\n\nProfesional**Ubicaciones de Publicación del Puesto:**\n\n\nCiudad Juarez, Chihuahua, México**Descripción del Puesto:**\n\n**Acerca de MedTech**\n\n**Impulsados por la innovación en la intersección entre biología y tecnología, estamos desarrollando la próxima generación de tratamientos más inteligentes, menos invasivos y más personalizados.**\n\n**Sus talentos únicos ayudarán a los pacientes en su camino hacia el bienestar. Obtenga más información en** **https://www.jnj.com/medtech**\n\n**Estamos buscando el mejor talento para ANALISTA DE QUEJAS I (PLAZO FIJO 12 MESES)** \n\n\n\n**Propósito:**\n\nBajo supervisión general, el Analista de Quejas I será responsable de mantener los procesos de calidad asociados con el manejo de quejas de productos, procedimientos y controles para garantizar que todas las quejas se procesen de acuerdo con los procedimientos establecidos por la empresa y con las normativas y estándares internacionales. Este profesional revisará documentación proveniente de llamadas entrantes, faxes y correos electrónicos de todas las regiones del mundo. Asimismo, obtendrá información suficiente para asegurar una documentación adecuada, investigación (incluyendo pruebas del producto) y cierre de cada queja, con el fin de tomar y documentar decisiones o justificaciones sólidas sobre notificación regulatoria para reportes a nivel mundial. La persona aplicará prácticas y técnicas estándar en situaciones específicas, ajustará y correlacionará datos, reconocerá discrepancias en los resultados y seguirá las operaciones a través de una serie de pasos y procesos detallados relacionados.\n\n**Será responsable de:**\n\n\nBajo supervisión general y de acuerdo con todas las leyes/regulaciones federales, estatales y locales aplicables\n\n\ny con los procedimientos y directrices corporativas de Johnson \\& Johnson, este puesto:\n\n\nActividades relacionadas con el manejo de quejas:\n\n* Responsable del manejo de quejas (ingreso, seguimientos, análisis de producto, cierre, etc.)\n* Posee un conocimiento profundo de la base de datos de quejas.\n* Comprende los principios básicos, teorías, conceptos y técnicas relacionadas con las quejas de clientes.\n* Establece informes para la revisión inmediata de nuevas quejas, decisiones de notificación regulatoria y seguimiento.\n* Desarrolla, establece, prepara y distribuye paneles de control e informes para asegurar que las quejas se procesen de manera oportuna.\n* Es responsable de codificar el evento y garantizar que se obtenga y documente toda la información requerida para un expediente de queja, a fin de tomar una decisión final sobre notificación regulatoria.\n* Evalúa toda la información desde una perspectiva clínica y técnica para asegurar que antes del cierre de la queja se haya documentado un análisis, investigación, causa raíz y revisión de ingeniería de calidad adecuados.\n* Ejecuta diariamente el análisis de quejas e investigaciones de fallas y documenta los resultados del análisis y la información relevante en los informes Med Watch para las familias de productos asignadas.\n* Aprueba las quejas en las familias de productos asignadas.\n* Organiza reuniones sobre quejas y comunica eficazmente con grupos mundiales de quejas, así como con otros departamentos internos como Marketing, I\\&D, Servicio al Cliente y Servicios Técnicos.\n* Redacta cartas de respuesta al cliente según sea necesario.\n\n\nActividades relacionadas con tendencias y escalación:\n\n* Escala problemas críticos para su disposición adecuada cuando sea necesario y de acuerdo con los procedimientos de escalación aplicables.\n\n\nOtras asignaciones:\n\n* Brinda apoyo en la capacitación del proceso de quejas para nuevos analistas o técnicos si se le ha identificado como experto en el tema.\n* Investiga y desarrolla soluciones relacionadas con problemas de procedimientos y procesos.\n* Puede recibir orientación técnica sobre problemas complejos, pero determina e independientemente desarrolla enfoques y soluciones.\n* Participa en procesos y proyectos de mejora de calidad.\n* Brinda apoyo en la transferencia de productos y en el desarrollo de nuevos productos según sea necesario.\n* Garantiza el cumplimiento de las políticas y procedimientos del Sistema de Calidad de la empresa y de los requisitos y estándares externos aplicables, incluyendo FDA, ISO 13485, CMDCAS, PMDA y otras agencias regulatorias mundiales, las prácticas de Johnson \\& Johnson en materia de Medio Ambiente, Salud y Seguridad, y otros estándares aplicables respecto a dispositivos médicos.\n* Es responsable de comunicar al siguiente nivel directivo asuntos u oportunidades relacionadas con el negocio.\n* Es responsable de garantizar el cumplimiento personal y empresarial con todas las regulaciones, políticas y procedimientos federales, estatales, locales y de la empresa.\n* Realiza otras tareas asignadas según sea necesario.\n\n**Requisitos / Calificaciones:**\n\n* Título universitario completo, preferiblemente en ciencias de la computación, ingeniería, ciencias físicas, biológicas o naturales.\n* Preferiblemente entre 0 y 2 años de experiencia en calidad, fabricación o áreas regulatorias en dispositivos médicos u otra industria regulada.\n* Certificación preferible de la American Society for Quality (ASQ), experiencia en Six Sigma y/o conocimiento de herramientas de Excelencia en Procesos.\n* Se requieren habilidades de pensamiento crítico e investigación.\n* Se requiere capacidad para realizar múltiples tareas, incluyendo la capacidad de comprender los requisitos del cliente, recuperar información relevante y proporcionar respuestas satisfactorias y con inmediatez.\n* El empleado debe ser capaz de priorizar y gestionar eficazmente múltiples actividades y responsabilidades.\n* Se requiere capacidad para entender y seguir procedimientos escritos complejos. 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