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Senior Quality Engineer

Abbott
Portsmouth, United Statesfull_timeVerifiedPosted 21 Jan 2025
💰 $170,700/yr($85,300/yr$170,700/yr)

About the role

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 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Senior Quality Engineer

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’ll also have access to:

  • Career development with an international company where you can grow the career you dream of.

  • Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

  • An excellent retirement savings plan with 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 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.

The Opportunity

Abbott Rapid Diagnostics (formerly Alere) is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies. The position of Senior Quality Engineer is within our Toxicology Business Unit located at Instant Technologies, Inc. in Portsmouth, Virginia (also supporting Norfolk, Virginia location). In this role, you will be responsible for identifying, leading and/or supporting quality, regulatory and compliance improvement initiatives; execute highly complex or specialized projects; adapt precedent and may make significant departures from traditional approaches to develop solutions. Responsible for designing and maintaining programs for the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met.

What You’ll Work On

  • Responsible for overseeing and instructing, directing and checking the work of operations staff.

  • Responsible for application of quality principles and complex analysis of quality records, reports to form recommendations for improvements.

  • Document quality issues and performance measures for management review.

  • Lead and/or contribute to quality system alignment, product/service, metrics and process improvement projects.

  • Act as quality assurance subject matter expert for support of validation and qualification activities, facilitating the application of validation/change controls, risk management, quality planning and implementation of validation or qualification plans.

  • Supports development and review of validation and qualification plans and test scripts.  May support projects in multiple quality systems.

  • Works closely with facilities, commercial, supply chain, information technology, operations, and sister site SMEs to prevent non-conformities and provide solutions to complex issues.

  • Support multiple projects, balancing priorities and resources to meet project and management expectations. 

  • Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. 

  • Demonstrates good judgement in selecting methods and techniques for obtaining solutions.

  • Serve as documentation and change control SME and support the change control process by reviewing proposed changes, performing risk assessments and assessing the adequacy of verifications and validations.

  • Lead and support the QI and CAPA processes by performing investigations and root cause analysis and determining action plans and driving the actions to closure.

  • Perform root cause analysis of quality issues.  Apply appropriate tools (e.g., statistics, fault tree analysis, etc.). Work with peers to develop corrective actions.

  • Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the co

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Company

Abbott

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