Quality Assurance Specialist
Core
Ensuring compliance with FDA QSR, ISO 13485, and CLIA/CAP regulations by managing incidents, deviations, nonconformances, and corrective/preventive actions (CAPA) in clinical molecular testing laboratories.
Role type
Quality Assurance Specialist (Medical Device/Diagnostic)
Builds
Quality management systems and incident resolution frameworks for clinical laboratories
Domain
Healthcare / Medical Devices / In Vitro Diagnostics
Deliverable
client delivery
Required skills
FDA 21 CFR 820 compliance, ISO 13485 knowledge, CAPA process management, root cause analysis, deviation handling, CLIA/CAP regulatory knowledge, LDT laboratory experience
Preferred skills
Process improvement, cross-functional collaboration, audit support, trend analysis
Technologies
None stated
Responsibilities
Process and manage issues/incidents including deviations, NCs, and CAPAs; Participate in process improvements to the issue/incident reporting framework; Collaborate with Regulatory on health authority reporting; Assist in NC/CAPA activities including investigations and effectiveness verification; Drive ownership of issues/incidents to final resolution; Identify trends and provide metrics to drive root cause analysis; Participate as a subject matter expert during internal and external audits
Seniority
Mid-level, hands-on IC