Sr Microbiologist - (Danvers, MA)

JOB DETAILS Interfaces with Manufacturing, Quality, Engineering and Regulatory Affairs to define and oversee environmental and sterilization control processes to assure that Medtronic Danvers medical devices consistently comply with FDA, ISO and Medtronic qualifications. JOB QUALIFICATIONS · Manages the design, control and monitoring of ethylene oxide and gamma sterilization processes including writing sterilization validation and annual revalidation protocols and reports and/or reviewing and approving protocols and reports provided to Medtronic by contract manufacturers. · Reviews sterile load cycle data and performs sterile load release for finished product lots man ...