Descritivo de Cargo Quality EngineerAbout Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to: Career development with an international company where you can grow the career you dream of. A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.Main Purpose of the RoleWorks closely with Manufacturing and Engineering on sustaining activities to ensure compliance with the quality system requirements and achievement of Key Performance Indicators (i.E. NCMR’s, MA’s, Yield, Cost Reduction projects, etc.) and support/owns process/product validation activities. Works closely with Research and Development and Regulatory Affairs personnel (internal or external) to obtained support on sustaining activities and during new product introduction to assure compliance with product and regulatory requirements. Support of Major Quality System investigations (i.E. CAPAs, HHEs, StopShip, etc.) and audits (External / Internal).Main ResponsibilitiesVerify company´s adherence to the established Quality System and GMP/ISO standards.Assist in completion of risk management and risk analysis including FMEA.Work with R&D;/Design verification and design validation plans for products based on performance specification and risk analysis.Supports technical and statistical investigations concerning optimization and compliance to specification.Owner of measuring process capability, process controls, and process validation / efforts.Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities.Conducting NCMR Investigations, Calibration Out Of Tolerance (OOT)



Investigations and Complaint Investigations (MA) related to manufacturing Process.Completing and Documenting Monthly Quality Data Review, providing data analysis and escalation recommendations with minimum mentorship from higher level engineering.Leading Build At Risk (BAR) Authorizations & Closures.Completion and approval of document Change Requests, assuring accuracy, adequacy, and compliance to Quality System and product requirements.Creation and maintenance of Quality Plans and Reports, typically with minor mentorship from higher level engineering.Executing and authoring IQ, OQ, PQ, and/or PPQ Qualifications and Inspection and Test Method Qualifications, typically with minimum mentorship from higher level engineering.Conducting Statistical Data Analyses using Minitab typically with mentorship from higher level engineering.Maintenance/update Master Validation Plans and Reports.Supports activities during preparation and execution of audits (External / Internal).Perform supervisor activities to Quality Technicians, if required.EducationEducation: Bachelor’s career : STEM (Science, Technology, Engineering (preferred), Math) (with equivalent experience in medical devices or pharmaceutical quality control)ExperienceAt least 2 years of experience in Quality or Engineering positions.Proficiency in computer applications (MS Excel, MS Word, MS PowerPoint).Knowledge of statistical/data analysis and report writing experience.Experience working on FDA, GMP, and ISO 13485 Regulated environments.Experience in process improvement tools such as: Root Cause Analysis, Fishbone, Is/Is Not, Six Sigma or Process Control & Monitoring (SPC), Quality Tools.Experience with control of nonconforming material,



corrective and preventive actions as investigation owner and/or implementor.Knowledge on product and process qualification and validation.Other Qualifications and Education ASQ CQE / Six Sigma or similar certification Participation or leading multi-departmental project teams Experience in supervision role Language proficiency : English Intermediate- advanced RequiredAbbott is an Equal Opportunity Employer, committed to employee diversity.Connect with us at www.Abbott.Com, on Facebook at www.Facebook.Com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.The base pay for this position is N/A In specific locations, the pay range may vary from the range posted.Família de Cargo Operations Quality Divisão EP Electrophysiology Localidade Mexico > Queretaro: Avenida FINSA 156, Lote 12 Localidades Adicionais Turno de Trabalho Standard Viagem Not specified Vigilância médica Not Applicable Atividades de trabalho significativas Not ApplicableA Abbott significa o poder da saúde. Por mais de 125 anos, a Abbott tem ajudado as pessoas a alcançar seu potencial — porque uma saúde melhor permite que indivíduos e comunidades vivam melhor. Com uma rede integral e diversificada, que serve clientes em mais de 160 países, criamos novas soluções — em todo o espectro da saúde, em todo o mundo, para todas as fases da vida. Seja através da próxima geração de equipamentos de diagnóstico, dispositivos médicos para estilos de vida em transformação, nutrição baseada em ciência, ou novas reformulações, estamos desenvolvendo tecnologias mais inovadoras e revolucionárias na área da saúde para que indivíduos vivam melhor e com mais saúde. Os colaboradores da Abbott vêm trabalhar todos os dias com energia, entusiasmo e comprometimento com o intuito de promover a saúde e o bem-estar de milhões de pessoas. Eles superam os limites para ajudar a gerenciar e tratar alguns dos maiores desafios de saúde da vida. Convidamos você a explorar as oportunidades na Abbott, a ver se seus talentos e aspirações de carreira podem se encaixar com as nossas vagas. A Abbott é uma empresa que oferece oportunidades iguais e acolhe e incentiva a diversidade em nossa força de trabalho.Siga-nos: Facebook LinkedIn YouTube Twitter#J-18808-Ljbffr

📌 Quality Engineer - Querétaro Site (Santiago de Querétaro)
🏢 Abbott Laboratories
📍 Santiago de Querétaro