Principal Specialist, Software 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: 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, 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 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., suppler evaluations, lifecycle deliverable document(s), etc. to ensure that they comply with applicable procedures, standards, and regulatory requirements. Directs mulit-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, software engineering theories, methods, and research techniques apply 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. Apply 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 therefore may represent the division during internal and external inspections, such as FDA; ISO and AQR. Leads and support audits related to software life cycle and cybersecurity. Leads and support CAPAs. Required Qualifications Bachelors 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 Bachelors degree in engineering or computer science. ASQ certification related to software and/or CFR21 Part 11 compliance. Industry experience PMP Cybersecurity training or certification Apply Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: 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 abbott.com, on LinkedIn at and on Facebook at 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. JOB FAMILY: Operations Quality DIVISION: TM Transfusion Medicine LOCATION: United States > Lake Forest : CP01 ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 10 % of the Time MEDICAL SURVEILLANCE: Not Applicable 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), Work requiring repeated bending, stooping, squatting or kneeling Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: EEO is the Law link - Espanol: 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