Medical Device Process Validation Engineer

Charlotte, NC

Job ID: 128215 Industry: Med

 

 

Medical Device Process Validation Engineer

 Background:

Our client is a large medical device company that makes and manufactures minimally invasive catheters (Class 3 device) and catheter assembly kits. They are currently in need of a Process Validation engineer to help with execution of Process Validations for an R/D project.

Responsibilities:

The client is seeking a seasoned Validation Engineer to execute Process Validations for an R/D project related to Class 3 Minimally Invasive Catheters. Most of their processes are already set up and in place, but there is a great deal of validation that needs to be done. This consultant should be familiar with validating processes for class 3 medical devices, comfortable working cross functionally with all levels of engineering and upper management. This person should be familiarized with all current ISO standards as well. They will be working with IQ OQ PQ and writing process validation documentation as well.

Required:
  • Medical Device
  • Process Validation SME
  • Executer mindset

Plus:
  • Experience with Minimally Invasive Cathers
  • Design of experiments for Process Validation

Job Type: Contract  

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