Lead QA Microbiologist

The Lead Quality Engineer, Microbiology and Sterilization, serves as Capstan Medical's quality subject matter expert for sterility assurance and microbiological control. This role leads quality engineering oversight of the ethylene oxide (EtO), moist heat (autoclave), and liquid chemical sterilization processes that support Capstan's sterile products, along with the supporting microbiology and contamination control programs. The role partners closely with R&D, Operations/Manufacturing, Regulatory Affairs, Supplier Quality, and third-party sterilization and laboratory partners to ensure these activities meet Capstan Quality System requirements and applicable regulatory and standards expectations.

Core Responsibilities Sterility Assurance Leadership

•Serve as Capstan's quality subject matter expert for sterility assurance and microbiology, setting sterilization and microbiological control strategy with R&D, Operations, and Regulatory Affairs.

•Provide technical guidance, training, and mentoring to quality engineers, technicians, and cross-functional partners on sterilization and microbiology topics.