In this role, you have the opportunity to

Maintain the quality management system compliance by ensuring the quality procedures are implemented and followed.
Supervise NPI (New Project Introduction) project, and implement design controls requirement into NPI.
Concentrate on CFR820.30 Design control and ISO13485, EU MDD/MDR, MDSAP, ISO 14971 Risk Management, IEC62304 Software development lifecycle, IEC60601, IEC62366 Usability Engineering and any other regulation/standard applied to medical device and be expert of the above regulations.
You are responsible to

Be responsible for the design control in NPI/Sustaining Project/lifecycle management Quality Assurance. (Process)
Working with these cross-functional groups, develop quality engineering documentation independently, and lead their implementation. (Process