Senior QA 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

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.