Quality Engineer

Title - Quality Engineer Location - Temecula, CA(Onsite)Roles & Responsibilities: 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: Bachelor's 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