Senior Specialist Quality Assurance

Abbott Laboratories • Lewes, DE

15h • Onsite

About The Position

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. 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.

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.

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