Sr. Specialist Quality Assurance

About Abbott

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, our 115,000 colleagues serve people in more than 160 countries. We are recognized as one of the most admired companies in the world by Fortune and a great place to work for diversity, working mothers, and scientists.

About the Team

This role sits within the Non-Product Software Quality Assurance (SWQA) team for Abbott Diabetes Care. Our mission is to revolutionize how people monitor glucose levels through life-changing sensing technology. We help liberate over 500,000 people with diabetes from routine fingersticks by providing accurate data to drive better-informed decisions. The team ensures that the software systems supporting our quality systems and consumer products are developed, validated, and maintained in strict compliance with regulatory and corporate standards.

About the Role

As a Sr. Specialist Quality Assurance, you will be a key member of the SWQA team, ensuring that medical device software and applications meet rigorous FDA QSR, ISO guidelines (ISO 13485, ISO 14971), and 21 CFR Part 11 requirements. You will work independently to plan and coordinate your work according to higher-level project schedules, reviewing critical deliverables such as system specifications, verification test cases, and validation protocols.

Your day will involve collaborating with engineering disciplines and contractors to support the ADC Design Control Process. You will identify and report unexpected events or software bugs during verification and validation, assisting subordinate staff in recognizing similar issues. Additionally, you will support initiatives to improve the Non-Product Software Lifecycle process, ensuring continuous compliance and quality improvement.

Hiring Process

We are committed to finding the right fit for our team. While specific steps may vary, our process typically involves reviewing your application, followed by interviews focused on your technical expertise, project experience, and cultural alignment with Abbott's values.

Equal Opportunity Employer

Abbott is an Equal Opportunity Employer committed to employee diversity. We consider qualified applicants regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. We strive to create an inclusive environment where everyone can do work that matters and live a full life.