Quality Engineer I
26531 Ynez Road Temecula, CA 92591 US
Job Description
WHAT YOU'LL DO:
• Identify internal requirements and external laws, regulations, guidance and standards (LRGS) applicable to one or more of division's quality systems
• Ensure internal activities and external partnership activities meet applicable regulations and quality standards including
• FDA QSR and ISO 9001/ ISO 13485
• Ensure external partnership activities meet applicable regulations and quality standards including FDA QSR and ISO 9001/
• ISO 13485
• Interpret applicable internal requirements and external LRGS and incorporate into requirements for use in business
• processes internally or with external partners
• Maintain and communicate monthly metrics
• Review and approval of product design changes and Quality System documentation
• Maintain external partner files
• Create Quality System and/or external partnership related documents
• Review external partnership assessment forms and assist in execution of onboarding and maintenance activities
• Participate in external inspection/audit activities
• Perform other duties as assigned by Management
EDUCATION AND EXPERIENCE YOU’LL BRING:
Bachelors Degree in Life Sciences, Physical Sciences, Engineering discipline or equivalent technical
Minimum 0-2+ years Quality Assurance experience
Minimum 0-2+ years Medical Device manufacturing or pharmaceutical industries
Working Knowledge of applicable regulations and standards such as, FDA QSR and ISO 13485
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