Ron Koronkowski
Quality and Regulatory Professional
- Role
- Vice President of Quality Assurance and Regulatory Affairs at DuPont™ Spectrum™
- Location
- San Francisco, CA, US
- LinkedIn followers
- 500 followers
Manufacturing & ProductionView LinkedIn profile
About Ron Koronkowski
Seasoned professional with quality related leadership experience in the Medical Device…
Experience
Vice President of Quality Assurance and Regulatory Affairs
Jan 2024 — Present · Alpharetta, GA, US
Education
Illinois Institute of Technology
BS, Mechanical Engineering
1980 — 1984
Skills
- Design Control
- Validation
- Quality System
- Cqa
- Quality Management
- Root Cause Analysis
- Biocompatibility
- Medical Device Directive
- 21 Cfr Part 11
- Iso 13485
- Medical Devices
- Capa
- Spc
- Commercialization
- Catheters
- Lean Manufacturing
- Sterilization
- Regulatory Affairs
- Quality Auditing
- Quality Control
- Gmp
- Injection Molding
- Start-Ups
- Change Control
- Biomedical Engineering
- Product Development
- Design of Experiments
- Manufacturing
- Minitab
- Fmea
- Regulatory Submissions
- Manufacturing Engineering
- Leadership
- Iso
- Fda
- Cross-Functional Team Leadership
- Supplier Quality
- Iso 14971
- 21 Cfr
- Fda Gmp
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