Senior Quality Assurance Engineer, Non-Product Software Validation

Abbott • Lake Forest, IL

2d • $78,000 - $156,000 • Onsite

About The Position

This position works out of our Lake Forest, IL location in the Transfusion Medicine, 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. The Senior Quality Assurance Engineer, Non-Product Software Validation, is responsible for compliance with the non-product software Life Cycle supporting applications used throughout ADD. Uses software quality engineering principles to recommend unique tailoring approaches to allow the project to both meet its Software Life Cycle requirements and improve its development efficiency.

Requirements

• Bachelors Degree in Computer science, software engineering, or a closely related discipline or an equivalent combination of education and work experience.
• Minimum 4 years related work experience in Quality or a related field.
• Knowledgeable of FDA, Quality System Regulations (QSR), Medical Device Directive, ISO guidelines and 21 CFR Part 11.

Nice To Haves

• Master’s degree preferred.
• Project experience in software testing practices, methodologies and techniques, particularly in testing medical devices or experience leading test engineer team is a plus.

Responsibilities

• 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.
• Advises project management and participates in the quality aspects of software projects.
• Helps in the creation and improvement of software development and quality operating procedures.
• May lead in the creation and improvement of software development and quality operating procedures.
• Deals with mid-level management and outside entities in response to quality problems, needed process improvement, and audit observations.
• Reviews pre-defined deliverables/activities as identified in software quality assurance (SWQA) Non-Product Quality Process and/or SWQA Product Quality Process/project plan or equivalent project plan.
• Apply basic risk management principles to all activities and tasks to investigate non-conformances. Identifies areas for process improvement and provides supporting information for change, including reasons and justifications.
• Participates in the development or modification of validation packages and deliverables, including assessments (including risk assessments, e.g., FMEAs), plans, requirements, and protocols.
• Ensure compliance with relevant FDA QSR, ISO guidelines, including 21 CFR Part 11 and Abbott Corporate requirements as they relate to the development, validation and maintenance of computerized systems.
• Assists with supplier assessments and evaluations to ensure products and services meet quality requirements. May evaluate vendor capabilities to provide required products or services.

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: Senior