Quality Manager-Medical

Ensure that the processes of the Quality Management System are established, implemented, and remain effective. This includes ensuring compliance guidance to ISO 13485 and 21 CFR 820, complaint management, ensuring system auditing, continual improvement, and proper use of statistical methods. Championing lean manufacturing and continuous improvement activities to aid the Management Team in the optimization of all systems.

Reports key performance indicators to Senior Quality Manager on the performance of the QMS, including any improvement needs. Ensures that the awareness of customer requirements throughout the organization is promoted.