Senior Specialist Quality Assurance

Abbott

1d • Onsite

About The Position

Abbott is a global healthcare leader dedicated to helping people live more fully at all stages of life, with a portfolio spanning diagnostics, medical devices, nutritionals, and branded generic medicines. The company employs 115,000 colleagues in over 160 countries. Working at Abbott offers career development, access to free medical coverage (HIP PPO plan), an excellent retirement savings plan with high employer contribution, tuition reimbursement, the Freedom 2 Save student debt program, and the FreeU education benefit for a bachelor's degree. Abbott is recognized as a great place to work globally, including for diversity, working mothers, female executives, and scientists. This onsite position is located at Abbott's corporate Abbott Park, Illinois facility within the Abbott Quality and Regulatory (AQR) Global compliance audit function. This corporate program conducts Quality Systems audits across all of Abbott's manufacturing sites. The role is critical as product quality and regulatory problems can significantly impact consumer health, safety, Abbott's image, earnings, market share, and customer loyalty. The position has broad responsibility within AQR and all divisions, ensuring audit outputs effectively communicate compliance business risks and regulatory requirements to executive management. It supports Quality System audits and assessments in accordance with regulations, standards, and Abbott procedures, including audit preparation, documentation, data maintenance, and review of findings and reports for clarity and accuracy. The role also contributes to continuous improvement by identifying opportunities to enhance audit documentation, reporting, and overall process effectiveness. The Senior Quality Engineer participates in cross-divisional activities to integrate compliance trends, assessment outcomes, and regulatory developments into audit documentation and reporting. This position requires effective communication and collaboration with auditors, leadership, and stakeholders across divisions and corporate functions, operating with a high degree of independence and requiring sound judgment in applying regulatory and quality knowledge, and escalating issues when necessary. Decisions are guided by established procedures, current regulatory knowledge, and an understanding of business and operational impacts.

Requirements

• Four-year degree in a scientific, technical or compliance discipline or equivalent experience
• 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

Nice To Haves

• 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

Responsibilities

• 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.

Benefits

• 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
• Health and wellness benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees