Senior Quality Assurance Engineer – Non-Product Software Validation

Abbott Laboratories; Irving (TX); Vor Ort; USD 78.000 - 156.000; Vollzeit

Zusammenfassung

Abbott in Irving, TX is seeking a Senior Quality Assurance Engineer for Non-Product Software Validation. You will oversee the CSV lifecycle, from system implementation through retirement, ensuring compliance with FDA QSR, ISO guidelines, and 21 CFR Part 11 within the Transfusion Medicine, Diagnostics Division.

You will review validation deliverables, assess data integrity, and work with management and external partners to drive quality improvements and risk mitigation across computerized systems.

Qualifikationen

• Bachelor's degree in computer science, software engineering, or related field.
• Minimum 4 years of quality related experience.
• Knowledge of FDA QSR, ISO guidelines and 21 CFR Part 11.

Aufgaben

• Provide independent QA oversight for the computerized system validation (CSV) lifecycle, from system implementation through retirement
• Review and approve Data Integrity Assessments and ensure ALCOA+ compliance
• Apply software quality methods to investigate and solve quality problems
• Interact with mid-level management and external entities regarding quality issues and audit observations
• Review and approve validation deliverables (Plans, URS, FDS, Risk Assessments, IQ/OQ/PQ) and reports
• Assess and mitigate compliance risks related to electronic records, electronic signatures, data integrity, cybersecurity
• Participate in development or modification of validation packages and risk assessments

Kenntnisse

Software QA

Data Integrity

Regulatory Compliance

Risk Management

Validation Plans

Ausbildung

Bachelor's in CS/Software Eng

Master's degree preferred

Tools

GAMP 5

IQ/OQ/PQ Protocols

ALCOA+ principles

FDA QSR

21 CFR Part 11

Jobbeschreibung

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 Irving, TX 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.

What You’ll Work On

• Provide independent QA oversight for the computerized system validation (CSV) lifecycle, from system implementation through retirement
• Review and approve Data Integrity Assessments and ensure compliance with ALCOA+ principles.
• Apply established software quality and engineering methods to the investigation and solution of software quality problems.
• Deals with mid‑level management and outside entities in response to quality problems, needed process improvement, and audit observations.
• Review and approve validation deliverables, including Validation Plans, User Requirements Specifications (URS), Functional and Design Specifications, Risk Assessments, Traceability Matrices, IQ/OQ/PQ protocols, validation summary reports, and periodic review documentation.
• 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.
• Assess and mitigate compliance risks related to electronic records, electronic signatures, data integrity, cybersecurity, and computerized systems.
• 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, GAMP 5 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.

Required Qualifications

• 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.

Preferred Qualifications

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

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://abbottbenefits.com/

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 https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers.

The base pay for this position is $78,000.00 – $156,000.00. In specific locations, the pay range may vary from the range posted.