Ayesha Simon
Project Management Leader | Medical Device & Combination Product Expert | M&A Integrations | QMS | FDA/EUMDR/ISO Compliance | Driving Strategy & Execution
- Role
- Quality Integration Project Manager at Medtronic
- Location
- Chicago, IL, US
- LinkedIn followers
- 500 followers
About Ayesha Simon
FDA regulations can be complex to understand. I am an industry expert that is passionate…
Experience
Quality Integration Project Manager
Jun 2024 — Present
Skills
- Pharmaceutical Industry
- Sop
- Fda
- Process Improvement
- Cleaning Validation
- Design Control
- Medical Devices
- Capa
- Change Control
- Iso 13485
- Manufacturing
- Gmp
- Management
- Quality System
- V&V
- 21 Cfr Part 11
- Computer System Validation
- Quality Assurance
- Gamp
- Cross-Functional Team Leadership
- Validation
- Project Management
- Gxp
- Aseptic Processing
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