Quality Assurance Specialist
Core
Ensuring quality activities related to incidents, deviations, nonconformances, and corrective/preventive actions (CAPA) in clinical laboratories and medical device contexts.
Role type
Quality Assurance Specialist (Clinical Laboratory/Medical Device)
Builds
Compliance with FDA QSR, ISO 13485, CLIA/CAP, and other global regulations
Domain
Healthcare / Clinical Laboratory / Medical Device
Required skills
QA experience in clinical molecular testing laboratory (LDTs), knowledge of FDA 21 CFR 820, ISO 13485, IVDD, deviations/NC/CAPA processes, root cause analysis, cross-functional collaboration
Preferred skills
Process improvement, metrics analysis, training and guidance, subject matter expertise in audits
Technologies
FDA 21 CFR 820, ISO 13485, IVDD, CLIA/CAP
Responsibilities
Process and manage issues/incidents (deviations, NCs, CAPAs), participate in process improvements for issue reporting, collaborate on health authority reporting, assist in NC/CAPA investigations and closure, drive ownership of issues to resolution, identify trends and provide metrics, participate in internal and external audits
Seniority
Mid-level, hands-on IC