Haiyan Wei
Quality Assurance & Regulatory Affairs Professional at Medical Device Industry
- Role
- Glidewell Dental
- Location
- Irvine, CA, US
- LinkedIn followers
- 500 followers
About Haiyan Wei
Experienced professional with extensive medical device Software Engineering and QARA…
Experience
Present
Skills
- Fda
- Lean Manufacturing
- Continuous Improvement
- Project Management
- Process Improvement
- Risk Management
- Software Development
- Dmaic
- Regulatory Submissions
- Leadership
- Regulatory Analysis
- Global Regulatory Compliance
- Medical Devices
- Capa
- R&D
- Internal Audit
- Regulatory Reporting
- Change Management
- Product Management
- Product Quality
- Iso 13485
- Product Development
- Regulatory Requirements
- Medical Imaging
- Validation
- Healthcare
- Regulatory Affairs
- Six Sigma
- Regulatory Guidelines
- Quality Auditing
- Product Surveillance
- Complaint Investigations
- Quality Assurance
- Root Cause Analysis
- External Audit
- Cross-Functional Team Leadership
- Biomedical Engineering
- Quality Management
- Testing
- Quality System
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