Quality Engineer
CurrentField reports of medical device malfunctions and document the complaints according to relevant SOPsDiagnose and investigate the issue(s) using root cause analysis to close investigation in a timely mannerEvaluate complaints for reportability and obtain data necessary for submission of MDRs as requiredMonitor, investigate, and statistically analyze manufacturing trends for NCRs, CAPAs, and scrap/reworkResponsible for generating and maintaining spreadsheet used to… Show more Field reports of medical device malfunctions and document the complaints according to relevant SOPsDiagnose and investigate the issue(s) using root cause analysis to close investigation in a timely mannerEvaluate complaints for reportability and obtain data necessary for submission of MDRs as requiredMonitor, investigate, and statistically analyze manufacturing trends for NCRs, CAPAs, and scrap/reworkResponsible for generating and maintaining spreadsheet used to track the status of open investigations Show less