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Quality Engineer - Sterilization

Company: Katalyst Healthcares & Life Sciences
Location: Ontario
Posted on: March 12, 2023

Job Description:

Roles & Responsibilities:

  • Is business with Sterigenics, they have a chamber they use for their product. They want to increase the capacity, purchasing a bigger chamber from 3 to 6 pallets. They need to finalize the implementation. Supplier quality is already completed, and validation documentation is already created-they need someone to pick up the work where the other consultant left off.
  • Getting a second supplier, with up to 6 pallets. Validation. Steris in Temecula. Also needs QE support for this implementation.
  • This person needs to finish the completion of the validations and have a strong sterilization understanding. (ETO)
  • There are also ongoing suppliers that they are looking Statistical Data, maybe Chemical Engineering Background
  • Run it by the end user, hands on in the packaging area, how we are prepping the product to go out.
  • Local Process that needs to be updated. Current chamber is 3 pallets, configuration needs to be changed. Preparation before it goes to Sterilization. Procedural Documentation work is the key
  • Validation
  • Sterilization Experience, ETO/EO
  • Medical Device QE
  • Chemical Engineering background

Keywords: Katalyst Healthcares & Life Sciences, Ontario , Quality Engineer - Sterilization, Engineering , Ontario, California

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