Principal Specialist, Software Quality Assurance

Principal Specialist, Software Quality Assurance Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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 a high employer contribution. Tuition reimbursement, 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity This position works out of our Lake Forest, IL location in the Core Lab, Diagnostics Division. We’re empowering smarter medical and economic decision‑making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. As the Principal Specialist, Software Quality Assurance, you’ll be the division subject matter expert for the non‑product software lifecycle, Data Integrity, and cybersecurity compliance. This position reviews and assesses software activities (e.g., supplier evaluations, lifecycle deliverable documents) to ensure that they comply with applicable procedures, standards, and regulatory requirements. Directs multi‑site and division‑wide software lifecycle activities to accomplish quality system objectives. Provides back‑up support to the manager as needed. What You’ll Work On Applies established software quality and engineering methods to the investigation and solution of software quality problems and Data Integrity. Leads in the creation and improvement of software development, software processes, and document processes. Reviews and approves software lifecycle deliverables. Provides regulatory interpretation/guidance division-wide and across divisions. Utilizes engineering and quality experience and knowledge to mentor project team and others. Consistently applies software engineering theories, methods, and research techniques to the investigation and solution of complex software quality problems. Leads the planning and implementation of the quality aspects of software projects. Leads in the creation and improvement of software development, document processes, and quality operating procedures. Deals with high‑level management and outside entities in response to quality problems, needed process improvement, and audit observations. Provides back‑up support to the manager as needed. Responsible for implementing and maintaining the effectiveness of the quality system. Applies established software quality and engineering methods to the investigation and solution of software quality problems. Reviews and approves software life‑cycle deliverables. The individual is the division subject matter expert for the non‑product software life cycle, Data Integrity, and cybersecurity and may represent the division during internal and external inspections, such as FDA; ISO and AQR. Leads and supports audits related to software life cycle and cybersecurity. Leads and supports CAPAs. Required Qualifications Bachelor's in engineering; scientific or technical discipline. Minimum 6 years’ experience in software discipline. Has led a last one significant project from beginning to end. Preferred Qualifications Bachelor's degree in engineering or computer science. ASQ certification related to software and/or CFR21 Part 11 compliance. Industry experience. PMP. Cybersecurity training or certification. Abbott is an Equal Opportunity Employer, committed to employee diversity. The base pay for this position is $99,300.00 – $198,700.00. In specific locations, the pay range may vary from the range posted. #J-18808-Ljbffr Abbott Laboratories