Hiring: Quality Operations Specialist Company: Hays Location: Irvine, CA Job Posted Time: 2026-09-11 11:53:35 Target Skills & Keywords : Microsoft Excel, R, Root Cause Analysis, SAP About the job Experience: •2-5 years of experience in Quality, Complaint Handling, Quality Engineering, Post-Market Surveillance, or related medical device quality functions. •5 years of experience in Quality, Complaint Handling, Quality Engineering, Post-Market Surveillance, or related medical device quality functions. Required Skills: •Review, evaluate, and investigate technical and clinical customer complaints in accordance with established procedures and timelines. •Perform hands-on troubleshooting and failure analysis of customer-returned devices and manufacturing nonconformities. •Document investigation findings and maintain accurate complaint files and quality records. •Support quality functions related to production, manufacturing line support, and SAP-based quality processes. •Assist complaint intake teams by reviewing and verifying complaint coding and documentation accuracy. •Monitor and analyze product performance through complaint trending, service data, and manufacturing rejection analysis. •Conduct root cause investigations and support implementation of corrective and preventive actions (CAPA). •Collaborate cross-functionally with Quality, Manufacturing, R&D, Supply Chain, Regulatory, and other teams to drive product and process improvements. Qualifications: •Bachelor's Degree in Engineering or Natural Sciences. •Knowledge of medical device quality systems and documentation requirements. •Strong written and verbal communication skills. •Proficiency in Microsoft Excel and other computer applications. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!