Senior Specialist Quality Assurance

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 115,000 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 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 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

This position works out of our corporate Abbott Park, Illinois location. The Abbott Quality and Regulatory (AQR) Global compliance audit function is a corporate program which conducts audits of Quality Systems across all of Abbotts Manufacturing sites. This is an onsite position.

Product quality and/or regulatory problems can negatively affect consumer health and safety, Abbott’s worldwide image, performance of Abbott earnings and market share and customer confidence and loyalty. The role has a broad responsibility that has significant impact throughout AQR and all divisions. The position is responsible for ensuring audit outputs are executed to ensure effective communication such that executive management is aware of compliance business risks and regulatory requirements.

The role supports Quality System audits and assessments conducted in accordance with applicable regulations, standards, and Abbott procedures. Responsibilities include supporting audit preparation activities, maintaining audit documentation and data within designated systems, and reviewing audit findings and reports to ensure clarity, accuracy, and alignment with established requirements. The role also supports continuous improvement by identifying opportunities to enhance audit documentation, reporting practices, and overall audit process effectiveness.

The Senior Quality Engineer participates in cross‑divisional activities to support the incorporation of compliance trends, assessment outcomes, and regulatory developments into audit documentation and reporting. The role requires effective communication and collaboration with auditors, audit leadership, and stakeholders across Divisions and corporate functions.

This position operates with a high degree of independence and requires sound judgment in managing assigned responsibilities, applying regulatory and quality knowledge, and determining when issues should be escalated for management awareness or involvement. Decisions are made using established procedures, current regulatory knowledge, and an understanding of business and operational impacts.

What You’ll Work On

• Support audit preparation activities by reviewing and organizing audit documentation and ensuring required information is available in designated audit systems.
• Support auditors during audit execution by coordinating documentation requests, tracking status, and facilitating timely updates.
• Review and refine audit finding language to ensure clarity, consistency, and alignment with regulatory and internal requirements.
• Support completion of audit reports during audit execution, ensuring observations, findings, and conclusions are clearly documented and supported.
• Perform post‑audit reviews of audit reports to verify accuracy, technical alignment, and consistency prior to management review and approval.
• Act as an auditor supporting audit activities in accordance with applicable procedures and audit plans.
• Identify opportunities to improve audit documentation practices, reporting quality, a