Quality Engineer

4 weeks ago


Temecula, United States GForce Life Sciences Full time

WHAT YOU'LL DO:

  • Identify internal requirements and external laws, regulations, guidance, and standards (LRGS) relevant to the division's quality systems.
  • Ensure that internal activities and external partnerships adhere to applicable regulations and quality standards, including FDA QSR and ISO 9001/ISO 13485.
  • Interpret internal requirements and external LRGS, integrating them into business processes internally or with external partners.
  • Maintain and communicate monthly metrics related to quality systems.
  • Review and approve product design changes and Quality System documentation.
  • Manage external partner files and create related Quality System documents.
  • Review external partnership assessment forms and assist in onboarding and maintenance activities.
  • Participate in external inspection/audit activities.
  • Perform additional duties as assigned by Management.

EDUCATION AND EXPERIENCE YOU’LL BRING:

  • Bachelor's Degree in Life Sciences, Physical Sciences, Engineering discipline, or equivalent technical field.
  • Minimum of 0-2+ years of experience in Quality Assurance.
  • Minimum of 0-2+ years of experience in the Medical Device manufacturing or pharmaceutical industries.
  • Working knowledge of applicable regulations and standards such as FDA QSR and ISO 13485.

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