Quality Assurance (QA) Specialist

Location: Chicago, United States

Salary: $55,000–$70,000 per year

Company

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

What you will do

• Serve as a QA partner for client-specific projects, coordinating quality activities, deliverables, timelines, risks, and follow-up actions.
• Collaborate with project, product development, operations, regulatory, and other cross-functional teams to integrate quality requirements into project plans.
• Support client onboarding, pre-qualification, quality questionnaires, and the collection and review of supporting documentation.
• Manage NCRs, CAPAs, deviations, investigations, effectiveness checks, and related follow-up activities.
• Participate in internal, external, client, and regulatory audits and support the resolution of project-related observations.
• Review QMS documentation, monitor regulatory changes, support compliance activities, and identify process-improvement opportunities.

Requirements

• Project-management experience, including organizing workstreams, managing timelines and dependencies, tracking deliverables, and escalating risks.
• Client-facing and audit-facing experience with clear, professional communication of quality requirements and project status.
• Strong written and verbal communication skills and the ability to work with stakeholders at different levels.
• Self-motivated, flexible, detail-oriented, and able to work with minimal supervision.
• Willingness to learn and apply applicable quality standards, regulations, and internal procedures.

Nice to have

• 1–3+ years of QA or QMS experience in a medical device, IVD, or other FDA-regulated environment.
• Experience with product development, design controls, design transfer, verification, validation, or commercialization.
• Experience supporting internal, external, client, or regulatory audits and inspections.
• Experience in a molecular testing laboratory or with laboratory-developed tests.
• Familiarity with FDA regulations and quality standards for medical devices and IVDs.

Culture & Benefits

• Full-time employment with benefits that may include medical coverage and other benefits.
• Potential incentive compensation and restricted stock units depending on the position.
• Work across project, product development, operations, regulatory, client, and external partner groups.