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# Senior Quality Assurance Engineer - Non-Product Software Validation

- **Company:** Abbott Laboratories
- **Location:** Irving, TX, United States
- **Experience:** Expert
- **Salary:** $78,000.0 - $156,000.0
- **Contract:** Permanent contract
- **Skills:** Testing (Software), Software Quality, Failure Mode Effects Analysis, Software Product Management, Software Engineering, Software Quality Assurance (SQA), Information Technology
- **Published:** October 6, 2026
- **Apply:** https://abbott.wd5.myworkdayjobs.com/abbottcareers/job/United-States---Texas---Irving/Senior-Quality-Assurance-Engineer---Non-Product-Software-Validation_31163599-1

## About the Role

* Bachelors Degree in Computer science, software engineering, or a closely related discipline or an equivalent combination of education and work experience. Master's degree preferred.
 * 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., * Project experience in software testing practices, methodologies and techniques, particularly in testing medical devices or experience leading test engineer team is a plus.

## Description

* 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.