Quality Assurance Engineer

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Working at Abbott   At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to:  • Career development with an international company where you can grow the career you dream of.  • Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.  • An excellent retirement savings plan with a high employer contribution.  • Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.  • A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.  • A company recognized as one of the best big companies to work for, as well as one of the best places to work for diversity, working mothers, female executives, and scientists.  The Opportunity   This position supports Operations within the Cancer Diagnostics business.  As a Quality Assurance Engineer, you will partner with Facilities, Service & Metrology, Process and Controls Engineering, Instrument Production, Reagent Manufacturing, Quality Control, and other areas of Operations. Depending on the assigned area, you will provide Quality oversight of products, materials, manufacturing and QC laboratory equipment and processes, instrumentation, facilities, utilities, and associated systems through qualification and validation, risk management, investigations, change control, and continuous improvement.   What You'll Work On   • Provide Quality Engineering oversight of manufacturing processes, instruments, equipment, facilities, utilities, and automated systems throughout their lifecycle, including qualification, validation, maintenance, calibration, and continuous improvement activities. • Review and assess engineering and manufacturing changes for potential impacts to product quality, process performance, equipment qualification, validated state, and regulatory compliance. • Lead or support investigations involving manufacturing deviations, nonconformances, out-of-specification results, equipment failures, calibration issues, and process or environmental monitoring excursions. • Support risk assessments, support root-cause investigations, and develop or evaluate corrective and preventive actions (CAPA) to address quality issues and drive sustainable improvements. • Provide Quality Engineering oversight of design and technology transfer activities, including manufacturing readiness, equipment and process qualification, verification and validation, risk management, and implementation of new or modified products and processes into Operations. • Partner with engineering and operational teams to evaluate process improvements, equipment modifications, automation and control system changes, and manufacturing or QC testing requirements. • Review and approve applicable Quality Management System records, engineering documentation, qualification and validation records, investigations, and change controls to ensure compliance with established procedures and regulatory requirements. • Exercise independent Quality Engineering judgment when evaluating technical issues, identifying compliance risks, and recommending appropriate actions to maintain product quality and process control.