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Validation Engineer

3 months ago

Fairfield, United States G.A. Rogers & Associates Full time

Our client in Fairfield, NJ is looking for a Validation Engineer for a Full time position.


Requirements:

  • Requires a 4-yr engineering degree or substitute experience; a graduate degree in engineering, technical, or management discipline is preferred.
  • Minimum of 5 yrs. experience in product quality position, with direct experience in quality system compliance.
  • Validation (IQ,OQ,PQ) or PPAP (Production Part Approval Process) required
  • Experience in medical device industry required.
  • Knowledge of GMP/ISO/21 CFR 820 Quality Systems required.
  • Working knowledge of Statistics (ie - Statistical Process Control (SPC) tools and methods, GR&R, MSA, etc) is required.
  • Knowledge of TQM, Six Sigma or Lean Manufacturing principles preferable.