Senior Quality Assurance Engineer - Medical Device San Jose, CA ref at ESR Healthcare

Senior Quality Assurance Engineer - Medical Device San Jose, CA ref Skills: Quality Assurance, Engineering, Medical Device, • Experience with FDA Quality System Regulations and ISO Standards (ISO 13485 and ISO 14971) is required, • Experience with non-conformances, CAPA, and Risk Management, • Experience in performing test method validation and Gage R&Rs;, • Extensive experience regarding root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram, 5 Whys…