Karen Davies
- Role
- OraSure Technologies, Inc.
- Location
- Salem, OR, US
- LinkedIn followers
- 500 followers
About Karen Davies
Medical device executive with over 20 years of experience, including product development,…
Experience
Present
Education
Stanford University
Bachelor of Science (BS), Mechanical Engineering
1983 — 1989
Stanford University
Manufacturing Systems Engineering
Skills
- Molecular Diagnostics
- U.s. Food and Drug Administration (Fda)
- V&V
- Strategic Planning
- Cross-Functional Team Leadership
- Testing
- Iso
- Business Planning
- Team Building
- Program Management
- Requirements Analysis
- Business Strategy
- Risk Management
- Medical Devices
- Capa
- Business Process Improvement
- System Architecture
- Product Development
- Validation
- Strategy
- Iso 13485
- Design for Manufacturing
- In Vitro Diagnostics (Ivd)
- Commercialization
- Quality System
- Fda
- Design Control
- Process Improvement
- Software Documentation
- Continuous Improvement
- Iso 14971
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