Sr. Quality Engineer (AI)

Location: Chicago, United States; other listed locations include Redwood City and New York City.

Salary: $110,000–$155,000 for Chicago/National roles; $120,000–$165,000 for NY/SF roles. Actual salary 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

• Implement and maintain QMS, SDLC, and medical device design control software tools, including eTQ and JAMA.
• Evaluate user needs, define system requirements and configurations, coordinate implementation, and liaise with third-party vendors.
• Facilitate system training, UAT activities, system enhancements, and troubleshooting of user experience issues.
• Perform and support computer system validation, testing regulated software against design specifications and user requirements.
• Support software engineering teams as a quality representative and drive risk-based validation, documentation, SOPs, training, and audit readiness.
• Support medical device software design controls, including DHF deliverables, FMEA, and risk management activities.

Requirements

• 5+ years of experience in a quality role within the medical device, IVD, or FDA-regulated industry.
• BA/B.S. or higher preferred in Computer Science, Software Engineering, Informatics, Biomedical Engineering, or a related engineering discipline.
• Working knowledge of FDA QSR, ISO 13485, IEC 62304, ISO 14971, Computer System Validation, and 21 CFR Part 11.
• Experience with SDLC tools including JAMA, JIRA, Atlassian, and eTQ.
• Experience with Agile, Scrum, or iterative software development methodologies.
• Ability to operate and innovate in a fast-paced environment while balancing business, compliance, and strategic needs.
• Excellent organizational, interpersonal, verbal, and written communication skills.
• Ability to deliver quality outputs under minimal supervision, adapt to changing assignments, and prioritize effectively.
• Ability to apply compliance requirements within computer systems environments, maintain compliance expertise, and support business goals.

Culture & Benefits

• Full-time employment with benefits that may include incentive compensation, restricted stock units, medical coverage, and other benefits depending on the position.
• Work involves collaboration with software engineering teams, subject matter experts, system vendors, auditors, regulatory authorities, and certified bodies.
• Equal opportunity employment with consideration in accordance with applicable fair-chance and employment laws.