Staff Quality Engineer, Microbiology and Sterilization
Core
Lead sterilization process development, validation, and requalification while ensuring microbiological control and biocompatibility compliance across the product lifecycle.
Role type
Staff Quality Engineer (Microbiology and Sterilization)
Builds
Sterilization processes, microbiological test methods, and compliance documentation for medical devices
Domain
Medical device manufacturing / Sterilization and Microbiology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Sterilization process development and validation, Microbiology program management, Biocompatibility evaluation, Regulatory compliance (FDA/ISO/GMP), Risk assessment, Nonconformance investigation, Cleanroom contamination control, Technical documentation authoring
Preferred skills
Biocompatibility evaluation principles, Supplier audit support, Risk management activities
Technologies
Ethylene Oxide (EtO), Gamma radiation, Electron Beam
Responsibilities
Lead sterilization process development, validation, and requalification; Develop and maintain microbiological test methods (bioburden, endotoxin, environmental monitoring); Investigate nonconformances and implement remediation plans; Support regulatory inspections and internal/external audits
Seniority
Staff, technical leadership