Quality Engineer

Avalign TechnologiesSchaumburg, IL

About The Position

The Quality Engineer is responsible for supporting the organization to ensure quality and production goals are met. The Quality Engineer will utilize an engineering approach to improve manufacturing efficiencies and ensure quality standards of all products are met.

Requirements

  • BS in an engineering science plus 1-5 years of quality experience in a manufacturing setting, or an equivalent combination of education and experience.
  • Ability to utilize statistical analysis and problem-solving techniques to determine product acceptance and evaluate process capabilities.

Responsibilities

  • Serves as a quality representative to assigned manufacturing areas and/or customers.
  • Responsible for ensuring compliance with Avalign procedures, customer requirements; and industry regulations, including FDA Quality System Regulation and ISO 13485.
  • Supports operations and engineering teams to ensure the Material Review Board process is followed.
  • Provides ongoing quality engineering support to operations, including risk management, developing appropriate inspection requirements; and complaint/ NC/ CAPA investigations.
  • Submit documentation to customers for new product launches and legacy product documentation requests.
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