Tempus
Quality Assurance Specialist
$55K–$75K
Chicago · Full-time · Posted Oct 20, 2026
- Experience
- Preferred: 1–3+ years of QA/QMS experience in a medical device, IVD, or other FDA-regulated environment.
About the job
Coordinates quality activities for client projects, supporting compliance, audits, quality-system processes, and communication with internal and external stakeholders.
What you'll do
- Coordinate project quality activities, timelines, deliverables, risks, and follow-up actions with cross-functional teams and clients.
- Track NCRs, CAPAs, deviations, investigations, effectiveness checks, and project-related audit observations.
- Review QMS documentation for international compliance and support regulatory readiness and process improvement.
What they ask for
- Demonstrated project-management experience organizing workstreams, timelines, dependencies, and deliverables, and escalating risks.
- Client-facing and audit-facing experience communicating quality requirements and project status.
- Strong written and verbal communication skills and ability to work with stakeholders at different levels.
- Self-motivated, flexible, detail-oriented, able to work with minimal supervision, and willing to learn applicable standards and procedures.
Nice to have
- 1–3+ years of QA/QMS experience in a medical device, IVD, or other FDA-regulated environment.
- Experience with product development, audits or regulatory inspections, molecular testing laboratories or LDTs, or applicable FDA regulations and quality standards.
Pay
$55,000-$75,000 USD base salary
Tools
QMS, NCRs, CAPAs, FDA, IVD, LDTs
Model-written summary · the original posting is authoritative