Quality Engineer Ii
Current- Investigated 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.