Michael Aymami
- Role
- Senior Director, Device Regulatory & Quality at TriSalus Life Sciences
- Location
- Boulder, CO, US
- LinkedIn followers
- 500 followers
About Michael Aymami
Established regulatory and quality system leader in the medical technology space. Strong…
Experience
Senior Director, Device Regulatory & Quality
Jan 2022 — Present
Education
San José State University
Bachelor of Science (BS), Industrial & Systems Engineering
Skills
- Lifesciences
- Lean Manufacturing
- 21 Cfr Part 11
- V&V
- Process Simulation
- Iso
- Root Cause Analysis
- Sop
- Quality Control
- Iso 9000
- Design of Experiments
- R&D
- Product Development
- Manufacturing
- Regulatory Submissions
- Biotechnology
- Pharmaceutical Industry
- Quality Assurance
- Spc
- Clinical Trials
- Medical Devices
- Validation
- Fda
- Quality Management
- Technology Transfer
- Hardware Diagnostics
- Minitab
- Commercialization
- Clinical Development
- Auditing
- Capa
- Product Launch
- Capital Equipment
- Supplier Quality
- Gmp
- Design Control
- Regulatory Requirements
- Cross-Functional Team Leadership
- Quality System
- Continuous Improvement
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