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Job #02607

About our client Our client offers a large selection of performance-driven solutions. The company’s solutions provide more effective and efficient ways to predict, investigate, monitor and treat disease. Their products and services offer the right balance of science, technology and practicality across the healthcare range. It provides medical professionals with very important information they need to deliver better, more personalized healthcare to patients. Position Location Quality/Commissioning Engineer Los Angeles, CA Salary Reports to Highly competitive package, commensurate with experience Management Responsibilities 1) Provide systems, programs and procedures that ensure that the in-vitro diagnostic device kits are manufactured, tested and released in compliance with FDA Device QSR regulations, ISO standards, internal standards and SOPs 2) Work closely with internal customers to identify procedural and systematic compliance risks and recommend practical, risk-based solutions that complement functional area business practices 3) Develop and conduct quality assessments of internal device QSR systems, processes and facilities 4) Manage a system of vendor audits and conduct audits as requested 5) Develop systems and programs to deliver device QSR training 6) Conduct training 7) Participate in regulatory inspections Requirements 1) BS/BA in Life Sciences or equivalent 2) 6+ years of experience working in a GxP environment 3) 4+ years quality assurance/systems experience or equivalent transferable skills 4) Working knowledge of FDA device, QSR regulations 21CFR820 and ISO 13485