Manager Quality Assurance
Core
Manage and coordinate all quality functions, compliance, and safety for a global sterilization and lab testing facility.
Role type
Manager, Quality Assurance
Builds
Mission-critical sterilization and lab testing services for healthcare, medical device, and pharmaceutical industries
Domain
Healthcare / Medical Device / Pharmaceutical / Sterilization
Required skills
Regulatory compliance (FDA, OSHA, ISO), corrective action management, audit coordination, process validation, risk analysis, personnel dosimetry management, change control, batch record review, training program management
Preferred skills
Food industry experience, ASQ certification, leadership potential
Technologies
None explicitly stated
Responsibilities
Maintain compliance with regulatory requirements (FDA, OSHA, EPA, USDA, NRC); coordinate internal and external audits; manage corrective actions and process improvements; oversee change control and process validations; maintain quality records and risk analysis; supervise QA personnel and training programs
Seniority
Manager, hands-on leadership