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Job #02769

About our client Our client is one of the world's leading medical device providers. They are a highly profitable, publicly traded company whose products are currently being sold in over 120 countries worldwide. This is a great opportunity for someone to join a company, which offers a great corporate culture and is focused on the long-term development of its employees. Position Location Senior Quality Assurance Representative North California Salary Highly competitive package, commensurate with experience Responsibilities 1) Develop, apply and revise procedures to maintain and improve quality compliance and standards 2) Review and approve concessions as denoted by applicable regulations and procedures 3) Assist in developing quality plans for assigned product line 4) Work with auditors and/or supervise inspection staff (if needed) 5) Analyze returned products and/or related reports to recommend corrective action and communicate with affected customers 6) Work with Engineering to ensure testing (as required) on product investigations is completed 7) Interact with customers to solve reliability issues and/or answer general product questions 8) Work from verbal and/or written instructions 9) Train others in quality assurance/GMP-related topics 10) Develop process controls and analyze data 11) Optimize operational parameters 12) Apply knowledge of applicable international regulations and standards (QSR, MDD, 13485, CMDCAS, etc.) 13) Coordinate activities of one or more QC inspectors and/or technicians and evaluate their performance based on pre-established performance parameters Requirements 1) BS/MS in Engineering (Mechanical, Electrical, Industrial, Software, Computers) or Science (Biology, Physics, Chemistry, etc.) 2) Quality Engineer certification 3) Minimum 2 years in quality assurance or a related functional area 4) Knowledge of inspection methods in designing and production of medical devices 5) Good understanding of QSR, ISO13485 and applicable regulations 6) Familiarity with design control principles 7) Ability to analyze and resolve non-routine product issues using independent judgment with assistance of engineering (as required) 8) Ability to meet qualifications of QA representatives 9) Excellent visual acuity 10) Ability to apply 10 pounds of force (occasionally) and/or a negligible amount of force to lift or carry things, including walking around the plant