Principal Specialist, Software Quality Assurance

Abbott Laboratories • Lake Forest, IL

1d • $99,300 - $198,700 • Onsite

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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

Responsibilities

• 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.

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 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal