Medical Device Sterilization SME (Remote)

Los Angeles, CA

Job ID: 123867 Industry: Med

 

Medical Device Sterilization SME (Remote)

Environment:

Our client is a large Medical Device organization that develops and manufactures a number of Class II & Class III medical devices, primarily in the Cardiology & Endovascular spaces.   They are currently in need of a Sterilization SME to provide  day-to-day Sterilization and Sterility Assurance support.

Project Scope:

  The consultant will be from a Medical Device background and should  have strong experience with conducting EO/EtO Sterilization (Ethylene Oxide). This individual should also have experience writing and executing Sterilization Validation protocols, and they should be comfortable working cross-functionally between the Technical Operations, Quality and Engineering teams. 

The consultant will most likely have a Microbiology/Biology/Physics educational background.  They must understand the standards, methods, and FDA regulations relating to EO/EtO Sterilization.

Required:
  • Medical Device: 8+ years
  • EO/EtO Sterilization: 8+ years
  • Sterility Assurance/Sterilization Validation: 8+ years

Sterilization Standards/Methods/Regulations  

Job Type: Contract 

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