Quality Assurance Specialist (Medical Devices)

Location: Onsite in Chicago, United States; work Tuesday–Saturday or Sunday–Thursday.

Salary: $55,000–$70,000 per year.

Company

hirify.global develops a precision medicine platform that connects real-world evidence with clinical insights for healthcare providers.

What you will do

• Process and manage deviations, nonconformances, incidents, and CAPA activities.
• Support investigations, root cause analysis, effectiveness verification, and closure of quality issues.
• Improve and standardize issue and incident reporting frameworks and related quality systems.
• Collaborate with Regulatory teams on health authority reporting when required.
• Provide training and guidance to issue owners and drive timely resolution.
• Identify quality trends and metrics and support internal and external audits as a subject matter expert.

Requirements

• Bachelor’s degree in Engineering or a Science field.
• 1–3+ years of QA experience in a clinical laboratory, medical device, or diagnostics company.
• QA experience in a clinical molecular testing laboratory using laboratory-developed tests is required.
• Working knowledge of FDA 21 CFR 820, ISO 13485, IVDD, CLIA/CAP, and other applicable quality regulations.
• Working knowledge of deviation, nonconformance, and CAPA processes.
• Ability and willingness to work onsite in Chicago and manage multiple tasks independently.

Culture & Benefits

• Work in precision medicine and clinical healthcare technology.
• Benefits may include incentive compensation, restricted stock units, medical benefits, and other employee benefits depending on the position.