Quality Engineer With Medical Device

Found in: Appcast Linkedin GBL C2 - 2 weeks ago


Los Angeles, United States Master Compliance Full time

HM's top needs:

  1. Post-Market Quality Engineering experience
  2. Highly prefer product quality support vs manufacturing, testing or supplier quality experience
  3. Extended Core Team experience for product launch / later stage product development

Education Required: Bachelor’s in engineering, science or technology discipline

Years’ Experience Required: 4-10 years preferred.

Will the contractor be working 40 hours a week? If not, weekly estimate? 40 hours weekly

Responsibilities include the following but not limited to:

  • 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.

Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.



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