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Supplier Quality Engineer

Company: Pikemann
Location: Bothell
Posted on: August 6, 2022

Job Description:

Global medical device company focused on supporting customers and delivering high-quality products that endure over time and ensure clinical and economic utility is looking for a Supplier Quality Engineer to become the newest member of our QA/RA Team.
*This is a hybrid role, 3 days in office, 2 days working from home.
Qualifications

  • Bachelor's degree in Electrical or Mechanical Engineering or related discipline required; Master's or graduate level degree preferred
  • 5+ years of work experience demonstrating a strong level of expertise in supplier quality
  • 3+ years of experience in manufacturing
  • Excellent analytical, technical writing and verbal communication skills
  • Knowledge of FDA (820.50 & 60) and ISO (13485) requirements
  • Certified Quality Auditor (CQA, RAB) certificate or Certified Quality Engineer (CQE) certificate preferred
  • Experience with PPAP (Production Part Approval Process) requirements, tools, processes, and deployment
  • Knowledge of quality improvement tools, including statistical methods.
  • Up to 40% domestic and international travel is required

Keywords: Pikemann, Seattle , Supplier Quality Engineer, Engineering , Bothell, Washington

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