Description
The responsibilities of the role besides povide strategic leadership to the Quality Systems department, include to direct and impliment the companies quality systems. Drive consistency in the Quality and Regulatory Compliance programs and lead initiatives for global and individual solutions, including managing the capital and expense needs of these initiatives and the business performance.- Minimum Bachelor's degree required, Master level education preferred.
- Minimum of 10 years in a management role in the medical device industry and an expert in regulatory requirements for cGMP comprehension and appropriate interpretation and application.
- Knowledge with FDA Quality System requirements and guidelines, EU Medical Device Directive and associated harmonized standards, ISO 13485.
- Risk Management, including ISO 14971, FMEA, product testing, capability studies, control plans and PMS
- Six Sigma and Lean Manufacturing desirable
To find out more about Real please visit www.realstaffing.com