Quality Engineer With Medical Device

3 weeks ago


Los Angeles, United States Master Compliance Full time

Responsibilities:

  • Develops, modifies, and maintains quality system procedures.
  • Supports internal or external audit activities where needed.
  • Supports nonconformance investigations and dispositions.
  • Collaborates with operations, manufacturing, engineering, and regulatory functions to ensure quality standards are in place.
  • Supports new product introduction activities with product design transfer efforts, reviewing and approving plans and reports and supporting design qualifications.
  • Understand complex issues and consult with various functions to conduct meaningful analyses.
  • Training and coaching cross-functional peers on maintaining compliance to internal and external Quality requirements and regulations.
  • Driving clarity and consistency in documentation.
  • Leading CAPA projects and assisting with post market analysis.
  • Work under consultative direction toward predetermined long-range goals and objectives. Determine and pursue courses of action necessary to obtain desired results through consultation and agreement with others rather than by formal review of superior.
  • Participate on extended Quality core team for new products and serves as voice of post-market quality engineering.



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