Quality Engineer

Sunnyvale, CA 94089

Employment Type: Direct Category: Quality Engineer Job Number: 8860

Job Description

Qualifications:
  • Bachelor's Degree in Engineering or Technology
  • 5+ years of progressive experience in quality control/assurance, quality engineering in medical device, life science, or biotechnology industry experience required
  • Knowledge of ISO 13485, CFR 21 Part 820 required
  • Experience with Lean Manufacturing, Six Sigma
  • Background with NPI for high volume products
  • Demonstrated experience with quality processes for injection molded plastics
  • Knowledge of product inspection techniques, GD&T applications
Responsibilities:
  • Improve and implement quality program activities
  • Assemble reports and advise on action-items for customer feedback and failure investigations
  • Create risk management tools for new projects
  • Mentor other quality team members on new practices so team is aligned on goals
  • Ensure projects follow Design Control protocol, and metrics and deliverables are on-time

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