Senior Quality Engineer (AI)

Location: Hybrid, requiring three days per week in the office. Candidates can be based in Chicago, New York, or Redwood City.

Salary: $90,000–$130,000 for Chicago; $100,000–$150,000 for NYC/San Francisco. Actual compensation varies by location, qualifications, and experience.

Company

hirify.global develops a precision medicine platform that connects real-world evidence with clinical insights to support treatment decisions.

What you will do

• Lead verification, validation, and maintenance of host systems supporting medical devices.
• Develop risk assessments and risk-based testing strategies for host and computer system validation.
• Perform validation, re-validation, and change controls for AI, SaaS, and internally developed software.
• Author and review validation plans, requirements, protocols, user acceptance tests, risk assessments, and validation reports.
• Collaborate with quality, IT, and cross-functional teams on requirements, test execution, change management, and major incident processes.
• Provide CSV guidance, coaching, mentorship, and training to test engineers and support inspections and audits.

Requirements

• Bachelor’s degree or higher preferred in Computer Science, Software Engineering, Informatics, Biomedical Engineering, or a related discipline.
• At least 5 years of experience in an FDA-regulated domain such as medical devices, pharmaceuticals, or biotechnology.
• At least 3 years of experience in Computer System Validation.
• Experience with medical device software, design controls, GAMP 5, FDA 21 CFR Part 11, FDA Quality System Regulation, ISO 13485:2016, FDA 21 CFR 820.30, and IEC 62304:2006.
• Knowledge of quality system principles, practices, and standards for the life sciences industry.
• Ability to deliver high-quality work independently or with minimal supervision.

Culture & Benefits

• Full-time employment with a comprehensive benefits package.
• Benefits may include incentive compensation, restricted stock units, medical coverage, and other benefits depending on the position.
• Work in a regulated healthcare and precision medicine environment focused on clinical applications of AI.