Quality Engineer
  • Vernon Hills, Illinois, US
  • +914043515100
4 Days ago
Job Description
  • Design Assurance: Quality Planning (i.e., new product development, design excellence, and design transfer). Ensures that all design control and production / process control projects meet applicable regulatory (local and international), Corporate, and Unit requirements
  • Design and development planning, design input, design output, design review, design verification, design validation, design transfer, design changes, and design history file maintenance.
  • Champions and drives Lifecycle Risk Management throughout the business unit
  • Design risk management: Assure that appropriate risk management tools (i.e., FMEA's) are utilized for all programs and projects and that the tools used are consistent with applicable regulatory standards and industry practices.
  • Design control excellence: Continuous monitoring and improvement of the design control program/process to ensure best-in-class processes.
  • Change control: Ensure change control projects are comprehensively evaluated and executed per the change control process.
  • B.S. in Engineering, Engineering Technology, Science a minimum.
  • American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.) preferred
  • Minimum 3 years of experience with FDA regulated industry, preferably on product development programs.
  • NA

Required Skills
  • Quality Engineer

  • 2-4 Years of Experience

  • NA

Working Hours / Week
  • 40h