Senior QA Engineer - Life-Cycle Software Validation

Abbott; Irving (TX); On-site; USD 78,000 - 156,000; Full time

Job summary

Abbott in Irving, TX is seeking a Senior Quality Assurance Engineer for Non‑Product Software Validation within the Transfusion Medicine area of Diagnostics. The role oversees the CSV lifecycle from system implementation through retirement, applying software quality principles to meet Life Cycle requirements and improve efficiency.

The position requires strong regulatory knowledge, risk management, and collaboration with cross‑functional teams to ensure compliance with 21 CFR Part 11, GAMP 5, and

Qualifications

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

Responsibilities

• Provide independent QA oversight for CSV lifecycle from system implementation through retirement.
• Review and approve Data Integrity Assessments; ensure ALCOA+ compliance.
• Apply software quality engineering methods to investigate and solve quality problems.
• Interact with mid-level management and external entities for quality improvements and audits.
• Review and approve validation deliverables (validation plans, URS, IQ/OQ/PQ, risk assessments, traceability matrices, validation reports).
• Help identify process improvements and justify changes with data.

Skills

Software QA

Quality risk assessment

Data integrity

Regulatory knowledge

Education

Bachelor in CS/Software Eng

Master’s preferred

Tools

Validation plans

URS/IQ/OQ/PQ

Job description

Abbott in Irving, TX is seeking a Senior Quality Assurance Engineer for Non‑Product Software Validation within the Transfusion Medicine area of Diagnostics. The role oversees the CSV lifecycle from system implementation through retirement, applying software quality principles to meet Life Cycle requirements and improve efficiency.

The position requires strong regulatory knowledge, risk management, and collaboration with cross‑functional teams to ensure compliance with 21 CFR Part 11, GAMP 5, and