As QARA Manager you will spend 80% of your time on Quality, and 20% on regulatory affairs. You will be managing a small team consisting of a Deputy QA Manager, and 2 QC Administrators. The purpose of the role is to ensure efficient management and continued improvement of the QMS which is a simple system yet mature and well established.
The continued certification of ISO13485 will be your responsibility along with providing strategic planning and framework to achieve commercial and quality goals. You will ensure any changes to the Medical Device Directive/ Regulation and Quality standards are disseminated throughout the company and appropriate risk analysis and actions are managed.
Reference no: 35386
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