Associate Manager, Microbiology & Sterility
Core
Lead microbiology and sterility assurance efforts across multiple US manufacturing sites to ensure product quality, patient safety, and regulatory compliance.
Role type
Associate Manager, Microbiology & Sterility
Builds
Medical device manufacturing operations (Trauma & Extremities)
Domain
Medical Device Manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Microbiology, Sterility assurance, Environmental monitoring, Cleanroom controls, Endotoxin testing, Sterilization validation, Root cause analysis, CAPA management, Risk assessment, Team leadership
Preferred skills
People leadership, Cross-functional collaboration, Quality system knowledge (21 CFR 820, ISO 13485, ISO 11137, ISO 14644), New product introduction support, Lean methodology
Technologies
Microsoft Office, Quality/data systems
Responsibilities
Support oversight of microbiology and sterility assurance programs across four U.S. manufacturing sites, Coordinate cleanroom compliance and environmental monitoring programs, Assist in management of sterilization programs, Oversee day-to-day activities of an internal microbiology lab, Provide direct supervision and development support to a small team of microbiologists and QC technicians, Review microbiological data, investigations, and CAPAs
Seniority
Manager, hands-on IC with people leadership
