职位描述
Ensure SSME level quality system complying with relevant internal standards and relevant national regulations such as CFR 820, ISO 13485, MDD/MDR, China GMP, MDSAP etc. In principle, she/he reports to Quality director in SSME QT. major tasks:
1. Take responsible for overall SSME QMS.
2. Continuous improvement for SSME QMS related processes, by benchmarking and best practice sharing and align with BA/BLs.
3. Coordinate SSME Quality improvement project.
4. Coordinate all external QMS audit/inspection (TUEV, China FDA, FDA, MDSAP, EU/China Unannounced audit, Saudi etc.)
5. Lead communication and collaboration with authorities.
5. Support SSME QMR for the routing QM/RA management.