Senior Quality Assurance Specialist (Medical Devices)

Location: Chicago, United States; on-site position

Salary: $90,000–$120,000 per year

Company

hirify.global develops a precision medicine platform that connects real-world evidence with clinical care to provide actionable treatment insights.

What you will do

• Process and manage deviations, nonconformances, CAPAs, and complaints in line with applicable regulations and standards.
• Lead incident management from a quality engineering perspective and collaborate cross-functionally on resolution and process improvement.
• Improve and standardize issue management reporting systems and workflows.
• Support quality data trending, monitoring, complaint analysis, failure investigations, adverse event reporting, and field actions.
• Collaborate with Regulatory on health authority reporting and support external audits and inspections.

Requirements

• Bachelor’s degree in Engineering or Science.
• 3+ years of QA experience in a clinical laboratory, medical device, or diagnostics company.
• At least 3 years of experience with nonconformances, CAPAs, and complaints.
• Practical knowledge of FDA 21 CFR 820, ISO 13485, IVDR, CAP/CLIA, and issue management processes.
• Strong organizational, communication, problem-solving, prioritization, and follow-up skills.
• Ability to work on-site in Chicago.

Nice to have

• Experience with post-market surveillance or IVD/medical device vigilance reporting.
• Experience with external or regulatory agency audits and inspections.

Culture & Benefits

• Opportunity to contribute to precision medicine and healthcare innovation.
• Benefits may include incentive compensation, restricted stock units, medical benefits, and other company benefits depending on the position.