Quality Assurance Engineer II

Role: Quality Assurance Engineer II supporting the Plainsboro, NJ CMC Quality System, focused on medical device quality compliance. Responsibilities: monitor and track closure of NCs, CAPAs, and Complaints; review investigations for accuracy and completeness; guide cross-functional teams on root cause analysis and corrective actions; develop quality metrics; ensure compliance with FDA, ISO 9001/13485, Medical Device Directive, and CMDR; collaborate with investigators and vendors to resolve quality issues. Requirements: Bachelor’s in Science or Engineering; 3-5+ years in QA within medical device/pharma manufacturing; expertise in investigations, CAPA systems, and technical documentation; proficient in MS Office and statistical tools; strong organizational and communication skills; ability to work independently. High-Value: medical device manufacturing, regulatory compliance, quality system management, CAPA investigation, risk management, cross-functional collaboration. WorkSetup: onsite in Plainsboro, NJ; no travel specified.