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Quality Engineer I

Temecula, CA 92591

Posted: 04/03/2024 Employment Type: Contract Job Category: Engineering Job Number: 603413 Is job remote?: No Country: United States

Job Description

Pay is commiserate with experience and ranges from $30-35/hr

•    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

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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