Quality Engineer - Temecula, United States - GForce Life Sciences

GForce Life Sciences Temecula, United States

3 weeks ago

Description

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
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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