Manager Quality Assurance
Core
Manage and coordinate all quality functions, compliance, and regulatory reporting for a global healthcare sterilization and lab testing facility.
Role type
Manager, Quality Assurance
Builds
Mission-critical sterilization and lab testing services for the healthcare industry
Domain
Healthcare / Medical Devices / Sterilization / Regulatory Compliance
Required skills
Regulatory compliance (FDA, OSHA, EPA, USDA, NRC), Quality management systems, Corrective and preventive actions, Audit coordination, Risk analysis, Process validation, Change control, Data analysis, Team leadership, Training development
Preferred skills
Food industry experience, ASQ certification, People motivation
Technologies
GMP, ISO standards, Dosimetry systems, Environmental monitoring tools
Responsibilities
Maintain compliance with regulatory requirements; Coordinate internal and external audits; Implement corrective actions for non-conformances; Manage facility quality records and procedures; Supervise QA personnel; Coordinate process validations and calibrations; Conduct risk analysis and environmental monitoring.
Seniority
Manager, hands-on leadership