Paul Foderick
MEDICAL DEVICE COMPANY PROJECT CONSULTANT Quality Systems Engineer I Product Risk Evaluations and Documentation I Post Market Surveillance I QMS I Medtronic Medical Device Company
- Role
- Risk Management Consultant at Terumo Neuro
- Location
- Miami, FL, US
- LinkedIn followers
- 500 followers
About Paul Foderick
MEDICAL DEVICE PROJECT CONSULTANT - Medtronic, Abbott Labs, Olympus Surgical, Beckman Coulter, and Zimmer Biomet. DIRECT HIRE- CORDIS of JOHNSON & JOHNSON J&J Direct Position.15 Years. Contract Analytics and Database Developer with over 15 years of experience, focusing on the Medical Device Industry as well as open to other opportunities.Primary work on post-market risk-management reporting for Class II & Cardiovascular, Endovascular and Neurovascular products in 80 countries worldwide. Reporting data subjects included nearly all Subparts of Title 21, Part 820, with advanced role with 820.5, 820.22, 820.30, 820.40, 820.90, 820.100, Subparts K - O. FDA, BSI, ISO quality systems audit experience. OBIEE development from ETL to Analytics visualization, using SQL and XML.Extracted data and graphed parts-per-million rate information in EXCEL, CSV, Oracle. Severity-based trending with SAS and TableauRefined escalation process development and improvement for ad-hoc reports for DPRA and CAPA. Developed and monitored metrics, cycle times, KPI\'s for complaint handling and product return through Failure Analysis.Developed Reportability decision trees with Clinicians.Developed, improved and monitored data dictionary from CRM through Business Intelligence.Special project on biohazardous returned product packaging supplier successfully completed.Devoted Team Member with a clear focus on the development and improvement of Compliance SystemsSkilled Collaborator who surpasses industry standards to provide essential business analytics for companies seeking the highest quality of life for their customers
Experience
Risk Management Consultant
Oct 2023 — Present · Los Angeles County, CA, US
Product Risk EvaluationsHealth Hazard EvaluationRisk Documentation and Process Validation
Education
University of Minnesota
Bachelor of Arts - BA, English, Cognitive Psychology; Minor in Biology PRE MED
Shattuck-St. Mary's School
Physical Sciences
Skills
- Medical Devices
- Fda
- Iso 13485
- Capa
- Quality System
- Quality Assurance
- Process Improvement
- Gmp
- Design Control
- Six Sigma
- Manufacturing
- Quality Management
- Regulatory Affairs
- Cross-Functional Team Leadership
- Validation
- Root Cause Analysis
- 21 Cfr Part 11
- Continuous Improvement
- Quality Auditing
- Iso
- Quality Control
- Sop
- Iso 14971
- V&V
- Strategic Planning
- Product Launch
- Failure Mode and Effects Analysis (Fmea)
- Change Control
- Customer Service
- Product Development
- Public Speaking
- Microsoft Office
- Software Documentation
- Engineering
- Management
- Leadership
- Pharmaceutical Industry
- Research and Development (R&D)
- Lean Manufacturing
- Biotechnology
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