Senior QA Engineer — Non-Product Software Validation

Hardware FYI; 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 Diagnostics Division. You will apply software quality engineering principles to ensure compliance with FDA QSR, ISO guidelines, and 21 CFR Part 11 across computerised systems.

The role focuses on implementing and maintaining the quality system, leading risk assessments, validation packages, and collaboration with project teams to improve processes and product quality.

Qualifications

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

Responsibilities

• Implement and maintain the quality system across non‑product software.
• Apply software quality methods to investigate and resolve quality problems.
• Advise project management on quality aspects of software projects.
• Help create and improve software development and quality procedures.
• May lead in development and improvement of quality operating procedures.
• Coordinate with mid-level management and external entities on quality issues.

Skills

Quality assurance

Regulatory knowledge (FDA QSR, 21 CFR

Education

Bachelor's degree in Computer Science or Software Engineering

Master's degree preferred

Job description

Abbott in Irving, TX is seeking a Senior Quality Assurance Engineer for Non-Product Software Validation within the Diagnostics Division. You will apply software quality engineering principles to ensure compliance with FDA QSR, ISO guidelines, and 21 CFR Part 11 across computerised systems.

The role focuses on implementing and maintaining the quality system, leading risk assessments, validation packages, and collaboration with project teams to improve processes and product quality.