Leonard Glatkowski
Retired Service connected disabled veteran, EVP Regulatory/Quality & Customer Success, Quality and Regulatory SME
- Role
- EVP Quality Regulatory & Customer Success at Quality Means Business
- Location
- Columbia, TN, US
- LinkedIn followers
- 500 followers
About Leonard Glatkowski
Software Validation compliant to 21 CFR part 11, SAP/ERP and MDM, SME ISO 13•••••16…
Experience
EVP Quality Regulatory & Customer Success
Aug 2023 — Present · Boston, MA, US
Education
U of F, Vanderbuilt, Georgetown, MIT
PHD Biomedical Science
Skills
- Iso 13485
- Capa
- Medical Devices
- Quality System
- Fda
- Design Control
- V&V
- Fmea
- Spc
- Minitab
- Root Cause Analysis
- Dmaic
- Design of Experiments
- Iso 14971
- Gmp
- Product Development
- R&D
- Cross-Functional Team Leadership
- Design for Manufacturing
- Manufacturing
- Validation
- Lean Manufacturing
- Six Sigma
- Quality Assurance
- Quality Control
- Supplier Quality
- Iso
- Continuous Improvement
- 21 Cfr
- Iso 9000
- Manufacturing Engineering
- Engineering
- Quality Auditing
- Change Control
- Quality Management
- 21 Cfr Part 11
- Value Stream Mapping
- Biomedical Engineering
- Process Simulation
- Sop
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