Senior Specialist Quality Assurance

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 by Fortune. A company recognized as one of the best large companies to work for, and a best workplace 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 that conducts audits of Quality Systems across all Abbott’s 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, earnings, market share, and customer confidence. The role has broad responsibility with significant impact throughout AQR and all divisions, ensuring audit outputs are executed to communicate effectively so executive management is aware of compliance 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. 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 before 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, and standardization across audits. Support the integration of regulatory trends, assessment outcomes, and audit insights into audit documentation and reporting. Communicate effectively with auditors, audit leadership, and stakeholders to clarify documentation, address questions, and support timely audit closeouts. Apply established procedures, regulatory knowledge, and business understanding to assigned responsibilities, escalating issues as appropriate. The role involves up to 50% domestic and international travel. Required Qualifications Four‑year degree in a scientific, technical, or compliance discipline or equivalent experience. Required Skills Minimum 3 years of auditing experience or experience supporting compliance programs and experience in Quality Assurance or another function in the pharmaceutical, medical device, nutritional, or related industry. Excellent oral, technical, and written communication skills. Personal skills: tact, open‑mindedness, maturity, tenacity, decisiveness, self‑reliance, and sound judgment. Expert knowledge of Quality Systems and Regulatory Science. Preferred Experience Lead auditor certificate for Quality System audits. Persuasive, effective communication skills essential for working across divisional and technical areas. One or two years of experience in a Compliance or Regulatory Affairs role. Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at on Facebook at and on Twitter at @AbbottNews and @AbbottGlobal. The base pay for this position is $78,000.00 – $156,000.00. In specific locations, the pay range may vary from the range posted. #J-18808-Ljbffr Abbott Laboratories