Quality Assurance Coordinator
Core
Ensures laboratory quality system compliance with federal/state regulations (CLIA, CAP, ISO, FDA) through documentation, audits, and continuous improvement.
Role type
Quality Assurance Coordinator (Laboratory)
Builds
Regulatory-ready documentation and compliant quality management systems for clinical/analytical laboratories
Domain
Life Sciences / Clinical Diagnostics / Laboratory Services
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Management Systems (QMS) knowledge, Regulatory compliance expertise, Audit coordination, Documentation control, Change management, Root cause analysis, Supplier qualification, Training development
Preferred skills
Certified Quality Auditor (CQA), Six Sigma certification, Experience with ASHI/CAP/CLIA standards
Technologies
LIMS, Microsoft Office Suite
Responsibilities
Develop and maintain Quality Manual and policies; Coordinate internal/external audits and inspections; Manage documentation control and nonconformance logs; Track change requests and implementation; Conduct staff training on quality standards; Investigate incidents and perform root cause analysis; Maintain Approved Supplier List (ASL)
Seniority
Mid-Senior, hands-on IC