Quality Assurance Engineer IV
AbbVie
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
Ensure that our product is functional and safe for the end customer by understanding, developing and applying quality control systems, as well as analyzing, proposing and implementing improvement of quality and manufacturing processes, thinking about improving defects in a timely and efficient manner
Responsibilities
- Evaluate, propose and implement high complexity improvements in processes in the process quality area, seeking to strengthen processes while improving their efficiency, guided and advised by the area manager .
- Search for solutions to problems identified in the areas of manufacturing and process quality through the application of Lean tools.
- Support assigned root cause investigations (NCRs), as well as the development of action plans and the implementation of corresponding actions, during the established period of time. Review and Approve documents for High Impact NCR.
- Develop and establish new processes and procedures from a quality perspective based on the Risk system evaluation, be part of the process and product transfer projects from the planning stage to its operationalization with high understanding of the ISO standard and other regulations.
- Coach and train colleagues to achieve a high performance team following the department's purpose, as well as make high-impact decisions evaluating the risk in the absence of the manager.
- Review and approve quality plans and First Article Plans related to the production process with low to high complexity, as well as propose changes to PFMEAs, this for those projects where you are assigned as a Quality representative.
- Perform reviews to OT Core System documents as well as validation/qualification protocols (IQ, PPQ, IOQ, IO, PR, etc.) where assigned as a quality representative complex and advance system.
- Provide support to key company projects, including definition and implementation of controls Provide support to key company projects, including definition and implementation of controls.
- Ensure the order and cleanliness of the areas under your responsibility. (5's) and comply with quality GO's in the corresponding period.
- Do the other functions inherent to the position and those assigned by your immediate manager.
- Meet compliance with corporate and legal EHS requirements, by complying with internal policy and procedures. In addition, ensure compliance through the adoption of necessary strategies, internal controls, communication and training.
- Continuously maintain EHS results through leadership, commitment and participation in all EHS related initiatives.
Qualifications
- Bachelors degree in Industrial Engineering, Bussiness Administrator or related career.
- Desirable CQE (certified quality engineer certification) given by ASQ.
- Intermediate/advanced English proficiency.
- Advance Statistical Knowledge
Experience
- Experience of at least 3-5 years as a quality supervisor/quality engineer in the medical industry.
- Experience in product transfer, quality system, validations and manufacturing, new procedure definition, risk assessment documentation development. (Desired).
Additional Information
En AbbVie estamos comprometidos a cultivar una cultura laboral que promueva la inclusión, la diversidad y el crecimiento personal. Reconocemos que nuestro éxito colectivo se basa en el bienestar individual de nuestros colaboradores y es por eso que hemos diseñado un paquete de beneficios pensando en cada aspecto de su vida.
- Cobertura Mejorada de Salud y Bienestar: Nuestro personal administrativo goza de un seguro médico y dental integral, asegurando tranquilidad para usted y sus seres queridos.
- Vacaciones Extendidas: Creemos en el equilibrio entre el trabajo y la vida personal de nuestro equipo administrativo. Por eso ofrecemos días adicionales de vacaciones, más allá de los requisitos legales.
- Modelo de Trabajo Híbrido Flexible: Para los puestos elegibles dentro de nuestro personal administrativo, adoptamos un esquema de trabajo híbrido que le permite la comodidad de teletrabajar durante dos días a la semana.
- Seguro de Vida: Asegure el futuro de su familia con nuestra póliza de seguro de vida.
- Avance Educativo: Invierta en su futuro con nuestro programa de becas disponible para empleados y sus dependientes.
- Programa de Asistencia al Empleado (EAP): Acceda a apoyo profesional con nuestro EAP integral, que ofrece asesoramiento psicológico, legal y financiero.
- Servicios de Salud en la Empresa: Benefíciese de la comodidad de contar con un médico de la empresa y servicios de fisioterapia, demostrando nuestro compromiso con su salud y bienestar.
- Compromiso Comunitario y Social: Haga la diferencia con un día de voluntariado pagado, que le permite contribuir a la comunidad durante el horario laboral de la empresa.
- Beneficios Especiales de Permiso: Celebre sus logros de vida con días adicionales de permiso por matrimonio y disfrute de su cumpleaños con un día libre.
- Plan de Compra de Acciones para Empleados: Participe en el éxito de nuestra compañía comprando acciones a un precio especial exclusivo para empleados.
- Transporte y Comidas Subsidiadas: Disfrute de la facilidad de transporte y de las comidas con nuestros servicios de transporte y cafetería subsidiados.
- Asociación Solidarista: Únase a una comunidad enfocada en la ayuda mutua y disfrute de los beneficios que conlleva ser miembro.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
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