Medical Device Steam Sterilization/GAMMA/ETO SME

Los Angeles, CA

Industry: Med Job Number: 125699


Medical Device Steam Sterilization SME

Background: Our client is a large Medical Device manufacturer of  a number of Class I, II and III medical devices. They are in need of a Steam Sterilization SME to perform a Gap Assessment on one of their medical device Steam Chambers. The individual will be from a Medical Device GMP background, with strong hands-on Steam Sterilization. They will also be responsible for the creation of an Action Plan. They are also looking for this individual to have experience with (GAMMA) qualifying a new sterilizer at their Tijuana, Mexico site.

  The consultant must be comfortable in a fast-paced environment and able to hit the ground running. Responsibilities:
  • Performing/Identifying Gap Assessment
  • Writing Action Plan
  • Providing Strategic Recommendations on Remediation to Upper management.
  • Qualifying new sterilizer


  • Medical Device: 5-8 years
  • Steam Sterilization
  • Parametric Release
  • ETO

Job Type: Contract  

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