Senior QA Engineer, Non-Product Software Validation

Abbott Laboratories; Lake Forest (IL); On-site; USD 78,000 - 156,000; Full time

Job summary

Abbott in Lake Forest, IL is seeking a Senior Quality Assurance Engineer for Non-Product Software Validation to ensure compliance with the software life cycle across ADD. This role applies quality engineering principles to improve development efficiency and meet regulatory requirements.

Responsibilities include contributing to risk assessments, validation package development, and ensuring compliance with FDA QSR, ISO guidelines, and 21 CFR Part 11.

Qualifications

• Minimum 4 years related work experience in Quality or a related field.
• Knowledgeable of FDA QSR, ISO guidelines and 21 CFR Part 11.
• Experience with software quality assurance in medical devices is preferred.

Responsibilities

• Ensure the effectiveness of the quality system and software life cycle.
• Apply QA methods to investigate and resolve software quality problems.
• Advise project teams on quality requirements and process improvements.
• Develop or modify validation packages, plans and protocols.

Skills

Quality Assurance

Regulatory Knowledge

Education

Bachelor's Degree in Computer science/ software engineering

Master’s degree preferred

Job description

Abbott in Lake Forest, IL is seeking a Senior Quality Assurance Engineer for Non-Product Software Validation to ensure compliance with the software life cycle across ADD. This role applies quality engineering principles to improve development efficiency and meet regulatory requirements.

Responsibilities include contributing to risk assessments, validation package development, and ensuring compliance with FDA QSR, ISO guidelines, and 21 CFR Part 11.