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, 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 auditing experience or experience supporting compliance programs and experience in Quality Assurance or another function in the pharmaceutical, medical device, nutritional or related industry experience. Individual must have excellent oral, technical and written communication skills. Personal skills needed include tact, open-mindedness, maturity, tenacity, decisiveness, self-reliance and sound judgment. Have expert knowledge of Quality Systems and Regulatory Science Preferred Experience Lead auditor certificate for Quality System audits Persuasive, effective communication skills are essential with an ability to work effectively across divisional and technical areas One or two years 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: www.abbottbenefits.com 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 www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @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. JOB FAMILY: Operations Quality DIVISION: AQR Abbott Quality and Regulatory LOCATION: United States > Abbott Park : AP52 ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 50 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. Follow Us: Facebook LinkedIn YouTube Twitter