Sterilization Manager

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Location
Juarez, MX
Salary
$1 - $1
Job Type
Direct Hire
Date
Apr 11, 2018
Job ID
2588463
Sterilization Manager needed for medical device manufacturing facility located in Cd. Juarez, Mexico, across the border from El Paso, Texas.

Position Scope/Summary

This position will be responsible for compliance to regulation of product testing and sterilization of product. The Sterilization Manager will be expected to provide support to all quality systems related to Operations, Engineering, Quality team, Transfer team, and all customer requests and/or requirements.   It is an integral position that requires foresight to plan and execute tasks timely and accurately. There may be work related tasks not specific to this position description.   

Qualifications
  • 5-8 years’ experience in the Medical Device or other regulated industry with a quality assurance role in the pharmaceutical, healthcare or medical device sector essential, preferably in an FDA regulated environment
  • At least 3- 5 years or more in sterilization processing, i.e., EO, Gamma, etc.
  • Technical knowledge in sterilization validation, adoption, single lot release, etc. in both disciplines of EO and Gamma
  • At least 3-5 years or more in laboratory testing, test methods and test method validation
  • Technical expertise in test methods per USP, federal and ISO standards
  • Experience with FDA and ISO 13485 Certification inspections
  • Experience in supervising people 
  • Must have knowledge of computer software for the analysis of data
  • Experience in lean processes, i.e., Lean Labs, Six Sigma, etc.
  • Ability to organize and judge priorities in a dynamic, fast-paced environment and work independently with minimal supervision