Paul Olszewski
Seasoned Project Manager & Technical Contributor to the medical device industry: New Product Development, Manufacturing, Processes, Equipment Validation, Remediation, , Quality Systems, FDA compliance.
- Role
- Project Manager, Market Actions and Remediation at ICU Medical
- Location
- Carlsbad, CA, US
- LinkedIn followers
- 500 followers
About Paul Olszewski
OVERVIEW:Leading and managing teams in medical device product development, FDA and ISO Quality Systems compliance, remediation. Technical contributor for equipment validations. specializing in \'short-term\' contracts where walk-on expertise is needed. • Manufacturing Processes • FDA Quality Systems Compliance • Change Management• IQ/OQ/PQ Validation • Product and Technology Transfers • ISO/ ROHS Compliance • Remediation • Product Development • Mechanical Design/DFM• Project Management/Planning • Lean Six Sigma Green Belt • Design Control• Technical Writing • Department / Group Management • Equipment & Product Transfers
Experience
Project Manager, Market Actions and Remediation
Jul 2025 — Present
Education
Rhode Island College
Bachelor of Science, Industrial Arts / Technology
Skills
- Quality Assurance
- Manufacturing Operations
- Process Engineering
- Rohs
- Quality Management
- R&D
- Quality Control
- Gmp
- Quality System
- Quality Systems
- V&V
- Team Leadership
- Document Management
- Process Simulation
- Corrective and Preventive Action (Capa)
- Software Documentation
- Root Cause Analysis
- Project Management
- Design Control
- Program Management
- Manufacturing Management
- Continuous Improvement
- Technical Writing
- Iso
- Business Process Improvement
- Fda
- Fmea
- Spc
- Change Control
- Dmaic
- Design of Experiments
- Manufacturing
- Cross-Functional Team Leadership
- Supplier Quality
- Iso 14971
- Iso 13485
- Engineering
- Six Sigma
- Management
- Team Synergy
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