Shamaila Rafiq
Director, Regulatory Affairs
- Role
- Director of Regulatory Affairs at Stryker
- Location
- Wayne, NJ, US
- LinkedIn followers
- 500 followers
About Shamaila Rafiq
Operations Quality professional specialization in Quality Systems, Quality assurance…
Experience
Director of Regulatory Affairs
Aug 2023 — Present
Education
New Jersey Institute of Technology
Bachelors, Computer Science
2000 — 2005
New Jersey Institute of Technology
Master, Manufacturing Engineering
2006 — 2008
The George Washington University
Graduate Certificate, Regulatory Affairs
Skills
- Quality System
- Engineering Change Control
- Leadership
- U.s. Food and Drug Administration (Fda)
- Erp
- Business Process Improvement
- Fda Gmp
- Process Improvement
- Gmp
- Windchill
- Root Cause Problem Solving
- Manufacturing
- Management
- 4d
- Cross-Functional Team Leadership
- Quality Management
- Root Cause Analysis
- Continuous Improvement
- Quality Assurance
- Medical Devices
- Integration
- 21 Cfr Part 11
- Validation
- Change Control
- Corrective and Preventive Action (Capa)
- Iso 13485
- Capa
- Fda
- Iso 14001
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