Luis Perez
Global Quality Leader
- Role
- Director, Quality - Laboratory Plastics Essentials at Thermo Fisher Scientific
- Location
- Tucson, AZ, US
- LinkedIn followers
- 500 followers
About Luis Perez
Quality Assurance, Engineering, and Operations for Medical Devices, IVD and commercial products• Global leadership roles • Business savvy, strong leadership, talent identification & team development• Medical Devices Manufacturing, Medical Device Package Development, and Product Sustaining• Working experience with New Product Development and Design Control • Proficient in Lean - Six Sigma, continuous improvement, and cultural transformation• Skilled in Technical Quality: Process and Test Method validation, Risk Management, and SPC• Highly skilled of FDA Quality System Regulations (21 CFR 820) and ISO Standards (ISO 9001 and ISO 13485)
Experience
Director, Quality - Laboratory Plastics Essentials
Jul 2018 — Present · Rochester, NY, US
Education
Pontificia Universidad Católica Madre y Maestra
BS
1989 — 1995
Skills
- Value Stream Mapping
- Process Improvement
- Engineering
- 5s
- Quality Control
- Gmp
- Design of Experiments
- Manufacturing
- R&D
- Design for Manufacturing
- 21 Cfr Part 11
- Design Control
- Quality Management
- Change Control
- Medical Devices
- Capa
- Validation
- Minitab
- Supplier Quality
- Iso 14971
- Dmaic
- Manufacturing Engineering
- Continuous Improvement
- Risk Management
- Fmea
- Iso 13485
- Iso
- Fda
- Six Sigma
- Quality System
- V&V
- Engineering Management
- Process Simulation
- Product Development
- Medical Packaging
- Process/Equipment Validation
- Lean Manufacturing
- Kaizen
- Root Cause Analysis
- Manufacturing Operations
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