Quality Assurance Manager
Core
Manage and coordinate all quality functions, compliance, and safety for a global healthcare sterilization and lab testing facility.
Role type
Senior IC Quality Assurance Manager
Builds
Mission-critical sterilization and lab testing services for healthcare, medical device, and pharmaceutical industries
Domain
Healthcare / Medical Device / Pharmaceutical / Sterilization / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory compliance (FDA, OSHA, EPA, USDA, NRC), Quality system management, Corrective and preventive action (CAPA), Change control, Internal audit execution, Risk analysis, Environmental monitoring, Process validation, Batch record review, Personnel dosimetry management, Training program development, Team supervision
Preferred skills
Food industry experience (for food irradiation facilities), ASQ certification, Leadership potential
Technologies
None explicitly stated
Responsibilities
Maintain compliance with regulatory requirements; Coordinate regulatory audits and internal compliance audits; Analyze facility data for trends and initiate corrective actions; Execute process validations and calibrations; Review and release batch records; Coordinate environmental monitoring and personnel dosimetry; Manage quality training programs; Supervise QA/Validation personnel
Seniority
Senior, hands-on IC with supervision responsibilities