Quality and Regulatory Specialist
Core
Develop, implement, and maintain a comprehensive quality management system (QMS) aligned with CLIA, ISO, and other accreditation standards for a laboratory environment.
Role type
Quality and Regulatory Specialist
Builds
Laboratory quality management systems and regulatory compliance frameworks
Domain
Healthcare / Laboratory Operations
Required skills
Quality management system (QMS) development, regulatory compliance (OSHA, CMS, CAP, CLIA, ISO), statistical data analysis, corrective and preventive action (CAPA) implementation, document control, root cause analysis (RCA), risk assessment, training program development
Preferred skills
MT/MLS degree, 5+ years laboratory operations experience, quality/regulatory function oversight experience, ASQ/NAHQ/ISO certification
Technologies
Laboratory Information System (LIS), Microsoft Office
Responsibilities
Serve as primary point of contact for external regulatory agencies; coordinate and support external inspections/surveys; conduct internal quality and safety inspections; identify and investigate non-conforming events and patient safety events; develop and maintain document control systems; support risk management and legal counsel in discovery requests; develop training materials and policies for laboratory staff
Seniority
Mid-level, hands-on IC