To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.

Job #02599

About our client Our client offers a broad portfolio of performance-driven diagnostic solutions that provide more effective and efficient ways to anticipate, analyze, monitor and treat disease. Their products and services offer the right balance of science, technology and practicality across the healthcare continuum to provide medical professionals with the vital information they need to deliver better, more personalized healthcare to patients around the globe. Position Location Quality Engineer Los Angeles, CA Salary Highly competitive package, commensurate with experience Responsibilities 1) Collaborate with other functional groups’ (e.g. Manufacturing, QC, R&D) personnel to ensure that in-vitro diagnostic device kits are manufactured and tested in compliance with FDA Device QSR regulations, internal standards and SOPs 2) Work closely with internal customer personnel to identify procedural and systematic compliance risks and recommend practical, risk-based solutions that complement functional area business practices 3) Conduct quality assessments of internal device QSR systems, processes and facilities 4) Maintain a CAPA system that tracks corrective action plans for product and process issues 5) Assist in maintaining vendor management system (e.g. vendor certification changes/rating and feedback systems/questionnaire analysis and follow up) 6) Schedule quality system training for personnel and maintain database of training activities 7) Provide timely compliance status reports to management 8) Assist Senior Quality System Specialist in preparing presentation 9) Maintain current knowledge of regulatory requirements 10) Participate in the maintenance of the Quality System group’s SOP system 11) Schedule Quality Review Board and Quarterly Quality Management Meetings Requirements 1) Bachelor's degree or equivalent experience 2) CAPA systems experience 3) 3+ years of quality experience 4) Medical device experience