Medical Device Sterility Assurance SME

Minneapolis, MN

Industry: Medical Device Job Number: 134288


Medical Device Sterility Assurance  SME


Our client is a manufacturer of single use medical devices. They are in need of a Sterility Assurance/Sterilization SME to come in and support a critical remediation project. The main focus is non conformance driven remediation of entire sterility assurance program and the selection of best practices moving forward.

Duties/Responsibilities/Scope of Work

This individual will come from a Medical Device background, and must have strong, hands-on experience in  sterilization for Medical Device manufacturing. This individual will come from a Microbiology background and have worked on multiple remediation efforts in the past.

The ideal candidate will have experience with EO Gas Sterilization, Environmental Monitoring, and Bioburden testing. They will be working with external manufacturing companies and well as internal teams. Responsibilities will include but not limited to; looking at issues on the manufacturing floor, monitoring compressed dry air systems, endo toxin testing, and the selection/ justification of sample sizes based on ISO class 8 standards and best practices. If the candidate had any experience designing and building Water Systems that would be a huge plus. Must have experience with Clean Room standards.

Any knowledge of the below ISO Standards would be beneficial to a candidates success:

ISO 17664, ISO 17665, TIR 30, TIR 12, ISO 11737-1, ISO11737-2,  ISO 11138-1, ISO 15883-1, ISO 15883-2, ISO 15883-5, ANSI/AAMI ST77, ISO 11138

Required Experience:
  • Medical Device 
  • Sterilization for Medical Device (EO Gas Sterilization)
  • Environmental Monitoring
  • Justification of Sample Sizes
  • Bioburden Testing
  • Clean Room Experience
  • Remediation Experience

  • Microbiology background
  • Experience Designing and Building Water Systems

Job Type: Contract  

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