We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination …
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Full-time
bachelor degree
Posted 48d ago
~40 hrs/week
Spanish
Responsibilities
The role is responsible for approving quality engineering specifications, developing validation protocols, and leading CAPA and risk management activities. It also involves managing non-conforming materials and ensuring compliance with FDA and ISO regulatory requirements.
Requirements
Requires a university degree in Engineering or a related field with 4 to 5 years of experience in similar roles. Proficiency in advanced English, basic SAP, and knowledge of medical industry quality standards (such as ISO 13485 and 21 CFR Part 820) is required.
Full job description
We are the people who give possibilities purpose
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
Job Description
Funciones y Responsabilidades Generales
Revisa y tiene autoridad de la aprobación de Ingeniería de Calidad para especificaciones de proceso/diseño nuevos y modificados, incluidas especificaciones de rendimiento del producto, métodos de prueba, etc.
Desarrolla protocolos de validación basados en las necesidades del negocio y las operaciones.
Asegurándose de que los programas de validación y desarrollo de productos cumplan con los requisitos de la FDA e ISO según aplique.
Lidera la ejecución del proceso de material no conforme (Notificación de calidad) según los procedimientos de la empresa, garantizando que los enfoques resulten en un control efectivo y operaciones eficientes. Provee las habilidades para la resolución de problemas.
Lidera CAPA relacionados con el área de responsabilidad. Realiza mejoras en los procesos y procedimientos de BD.
Evalúa la efectividad del Sistema de Calidad y Buenas Prácticas de Manufactura establecidos (Auditor en Capacitación)
Liderar actividades de gestión de riesgos moderadamente complejas, incluidas revisiones de gestión de riesgos, análisis de riesgos, actualización/mantenimiento del análisis de peligros de procesos y presentaciones a la junta de Gestión de Riesgos.
Garantiza que todos los proyectos de control de cambios de diseño y control de producción/procesos cumplan con los requisitos regulatorios (locales e internacionales), corporativos y de segmento aplicables.
Lidera el desarrollo de la medición y control de calidad para materia prima, proceso y producto; con el objetivo de implementar controles adecuados.
Genera reportes de métricos, analiza tendencias y escala situaciones de riesgo.
Roles y Responsabilidades Especificas
Analiza la información de la calidad y recomienda ajustes al proceso de manufactura, equipo y sistemas de calidad.
Lidera la Revisión y disposición de material no conforme en la junta de revisiones “MRB” y ordenes de cambio de ingeniería además da el seguimiento a acciones correctivas.
Realiza la implementación de controles de proceso, inspección y prueba en puntos estratégicos de producción.
Realizar estudios de capacidad del proceso en las líneas y calificación de métodos de prueba (TMV’s/MSA).
Realizas en auditorías internas y participa en externas.
Tiene autoridad para revisar y aprobar documentos controlados por el sistema de control de cambios.
Escala situaciones críticas o de riesgo a la Gerencia.
Lidera de acuerdo con sus funciones a la transferencia de productos o modificaciones a partes, materiales y procesos, así como en la implementación de nuevos productos.
Requisitos:
4 a 5 años en puestos similares
Titulo universitario (indispensable) en: Ingeniería o un campo relacionado
Ingles (Avanzado)
Experiencia en industria médica (deseable)
Conocimientos de Computación (Excel-Word), SAP básico.
Conocimientos en al menos dos estándares de calidad (21CFR parte 820 (QSR), ISO13485, ISO14971, ISO/TR 24971:2020, IEC 60601-1, IEC 62304, IEC 623666-1, ISO 10993-1).
Habilidad de trabajar de forma autónoma e independiente además de brindar orientación a ingenieros I (junior).
Experiencia en liderazgo de CAPA: ser dueño y completar con éxito los CAPAs.
Orientado al detalle, buena comunicación oral y escrita para trabajar con equipo multifuncionales.
Why Join Us?
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.
BD is the world's largest manufacturer and seller of medical equipment.
Industry
Medical Equipment Manufacturing
Company size
501-1,000 employees
Headquarters
纽约
LinkedIn followers
5,621
BD is one of the world's largest medical technology companies that produce and sell medical equipment, medical systems and reagents, dedicated to improving human health around the world.
BD focuses on improving drug treatment, improving the quality and speed of diagnosis of infectious diseases, and promoting the research and discovery of new drugs and vaccines.
BD has strong research and development capabilities to fight many of the world's most intractable diseases.
Founded in New York in 1897, the company is headquartered in Franklin Lake, New Jersey, USA and employs more than 25000 people in about 50 countries around the world.
The company's clients include medical institutions, life sciences research institutes, clinical laboratories, industrial units and the general public.
How many Science & Research jobs are open in Tijuana, Mexico right now?
There are currently 54 open science & research positions in Tijuana, Mexico listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Science & Research roles in Tijuana, Mexico?
Companies currently hiring include Qualcomm, Thermo Fisher Scientific, Medtronic, Becton, Dickinson and Company, Fresenius Medical Care, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Science & Research jobs in Tijuana, Mexico?
Yes — 3 of the 54 open science & research positions offer remote or hybrid work (2 remote, 1 hybrid).
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