Senior QA Engineer, Non-Product Software Validation

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

Benefits offered by this job

Free medical coverage (HIP PPO)

High employer retirement contribution

Tuition reimbursement

Freedom 2 Save student debt program

FreeU education benefit

Job summary

Abbott in Irving, TX is seeking a Senior Quality Assurance Engineer, Non-Product Software Validation to ensure compliance with software life cycle requirements across ADD. You will apply quality engineering principles to tailor approaches that meet lifecycle needs while improving development efficiency.

The role focuses on implementing and maintaining the quality system, addressing software quality issues, and guiding project teams.

Qualifications

• Bachelor's degree in Computer science, software engineering, or a closely related discipline; 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.

Responsibilities

• Implement and maintain the effectiveness of the quality system.
• Apply established software quality and engineering methods to investigate and solve software quality problems.
• Advise project management and participate in the quality aspects of software projects.
• Help in creation and improvement of software development and quality operating procedures.
• May lead in creation and improvement of software development and quality operating procedures.
• Deal with mid-level management and outside entities in response to quality problems and audits.

Skills

Quality assurance

Software quality

FDA regulations

ISO guidelines

Part 11 knowledge

Education

Bachelor's degree in Computer science or software engineering

Job description

Abbott in Irving, TX is seeking a Senior Quality Assurance Engineer, Non-Product Software Validation to ensure compliance with software life cycle requirements across ADD. You will apply quality engineering principles to tailor approaches that meet lifecycle needs while improving development efficiency.

The role focuses on implementing and maintaining the quality system, addressing software quality issues, and guiding project teams.