Jane Chai Email & Phone Number

Jane Chai Skills

• Regulatory Agencies
• Management of Direct Reports
• Attention to Detail
• QSR
• Class II
• Operational Planning
• Oral Communication
• IEC 62304
• IEC 60601
• Knowledge Acquisition
• Complaint Investigations
• Part 820
• cGMP manufacturing
• Customer Requirements
• Skilled Multi-tasker
• Written Communication
• Risk Management Tools
• Management Systems
• Communication
• Analytical Skills
• Teamwork
• Training
• Timelines
• Staffing Plans
• Team Leadership
• External Audits
• Software Compliance
• Regulatory Reporting
• Software Verification
• Packaging Engineering
• Regulatory Labeling
• Train Employees
• Management
• Vendor Qualification
• Quality Assurance Audits
• Industry Training
• Design Assurance
• Engineering Changes
• Regulatory Standards
• Reliability
• Technical Documentation
• Regulatory Audits
• Complaint Management
• Measurement System Analysis
• Quality Control Inspection
• Documentation Practices
• Management Review
• Flow Charts
• MDSAP Training
• Medical Device Regulation (MDR)
• ISO 13485
• FDA
• Medical Devices
• Quality System
• Quality Control
• Quality Assurance
• CAPA
• Manufacturing
• Design Control
• ISO 14971
• R&D
• V&V
• Start-ups
• Design of Experiments
• Biomedical Engineering
• GMP
• Validation
• ISO
• Supplier Quality Management
• Process Improvement
• Medical Device Directive
• CE marking
• Clinical Trials
• Catheters
• Change Control
• FMEA
• Supplier Quality
• Calibration
• Minitab
• Biotechnology
• Root Cause Analysis
• Iso 9000
• Regulatory Affairs
• Sterilization
• Quality Auditing
• SPC
• Gage R&R
• CQE
• 21 CFR
• Sop
• GD&T
• FDA GMP
• Quality Management
• DMAIC
• Design for Manufacturing
• Sterilization Validation
• Problem Solving
• Process Validation
• MDD
• Shipping Validation
• Leadership
• Start Ups
• Business Analysis
• Testing
• Marketing
• Project Planning
• Process Simulation