Quality Engineer Ii
CurrentInvestigated implanted chronic catheter and port product complaints to determine product failure modes and root causes. Assigned codes used for complaint trending.• Reviewed complaint investigations for accuracy and compliance to procedures and standards. Assisted in training new investigators to complaint investigation procedures and standards.• Investigated early-trend detection system statistical triggers for chronic catheter and port product complaints to determine if corrective and/or preventative actions are needed.• Reviewed and approved changes to drainage catheter, central venous chronic catheter, and implanted port product FMEAs.• Provided Quality Engineering support for EU MDR remediation for Navarre drainage catheters.• Provided Quality Engineering support for new product development for Navarre Provado drainage catheter and the Gully drainage bag project.• Conducted activities for investigation, implementation, and verification of effectiveness for Navarre drainage catheter CAPAs as a CAPA project lead.