Quality Assurance Lead
Core
Lead Quality Assurance processes to ensure compliance with CLIA, FDA, and GCLP regulations for a precision medicine company serving transplant patients.
Role type
Senior Quality Assurance Lead (Regulatory & Systems)
Builds
Quality Management System (EQMS) compliance and validated testing services
Domain
Healthcare / Precision Medicine / Genomics / Laboratory Testing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
EQMS administration, FDA/QMSR/ISO13485/CLIA regulatory knowledge, CAP audit experience, supplier qualification, corrective/preventive actions, batch record review, risk management, Design Control guidance
Preferred skills
PCR/RUO/IVD sequencing assay experience, NY State audit experience, document control database administration
Technologies
EQMS, Excel, Word, PowerPoint
Responsibilities
Manage EQMS system including user accounts, training, and maintenance; Execute software validation protocols; Lead CAPA, supplier qualification, and complaint handling; Review manufacturing batch records; Conduct internal and external audits; Provide quality guidance to personnel; Support design controls and risk management projects
Seniority
Senior, hands-on IC