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Validation/QA/ Manual Tester
Ref No.: 17-00077
Location: Seattle, Washington
Position Type:Contract
Start Date: 03/02/2017
Premarket Approval (PMA) validation
  • High level scope is writing a validation plan, high level user requirements for about 5-10 small tools (they would need to learn and understand the tools)
  • write some test procedures, execute the tests, and
  • write validation reports
  • Help in PMA submissions
  • Domain experience with 21 CFR. 814, 21 CFR. 820
Tasks & skills:
  • some examples of such tools are: a tool that pulls information out of a log file and generates reports; a tool that interacts with their instrument system and simulates a run; a tool that generates simulated sample reports from a config file; MD5 stamping/validation etc.
  • these resources would come in, learn what these tools do and then "reverser engineer " writing of test protocols, test cases and execute test procedures.
  • a plus (but not a must)- familiarity with test automation so that they can help the client team for the long term
  • some of these tools use SQL servers for data store