Assure R&D quality system compliance with world wide regulatory and company business requirements.
Provide management team insight of project status from independent perspective.
Build up quality culture and technical skill of improvement throughout R&D.
· Interpret and assist cross function teams to execute QMS processes during project operation.
· Lead project quality assurance activities compliant to China FDA registration and supervision requirements.
· Audit organization and project QMS execution to assess its compliance with regulatory requirements and defined processes.
· Identify and facilitate corrective and preventive actions, make sure CAPA effective and in time.
· Plan and implement world wide Gate-based PQA examination and track PQA findings through resolution and verification.
· Provide Process Coaching to Project Teams and individuals.
· Identify improvement opportunities through quality metrics collection and analysis, and facilitate improvement activities.
· Organize regulatory and quality assurance relative training to projects and functions.
1. Disciplined execution, innovative, quick learning, good team-work.
2. Experienced Quality Assurance body of knowledge and basic quality tool application skill.
3. B.S Degree in Software Engineering/ Computer Science/Biomedical Engineering or IT related major.
4. Relative design and test experience in above domain is preferred.
5. Good communication skill in both Mandarin and English.
6. CMMI and Six Sigma experience is plus.