Jeffrey Haderer

About Jeffrey Haderer

SPECIALTIES AND AREAS OF EXPERTISE- Global Quality Management Systems Implementation (ISO 13485, AS9100, 21CFR 820)- AS9100, ISO 13485 Lead Auditor- Lean Six Sigma Trainer- Manufacturing and Test Operations Remediation- Performance Metrics and Reporting- CAPA and Root Cause Analysis- Complaint Handling, MDR and Vigilance Reporting- Risk Management ISO 14971- Global Supplier Quality Implementation (development, management, and performance tracking)- Start-up, Site closures and Location Moves- Design Controls- Gap Assessments - FDA Remediations (Warning Letter & 483)- New Product Introductions (NPI)/Product Transfers- Verification and Validations- Process Validations - IQ/OQ/PQ\'s

Experience

1. Senior Quality Engineer Qa Manager

   St. Jude Medical

   Oct 2012 — Present · Irvine, CA, US

   Assisted in the implementation of projects related to CAPA’s and NCMR’s. Participated in design reviews and providing input for necessary activities. Test method development, risk analysis and design for manufacturing. Perform process qualification and validation protocols (IQ/OQ/PQ) and reports to ensure finished products and process meets the specifications and ISO 13485 requirements. Perform hands-on, bench type, and automated tests to consider and understand the root cause failure by using appropriate methodologies (FMEA).

Education

• Buffalo State University

  Bachelor of Science Degree, Industrial Technology

  1979 — 1983

Skills

• Design of Experiments
• Manufacturing
• Iso 13485
• Cross-Functional Team Leadership
• Supplier Quality
• Root Cause Analysis
• Fmea
• Statistical Process Control (Spc)
• Spc
• Failure Mode and Effects Analysis (Fmea)
• Process Improvement
• Product Development
• Testing
• Engineering
• Continuous Improvement
• Iso
• Quality Control
• Six Sigma
• Quality Management
• Quality System
• Lean Manufacturing
• Medical Devices
• Quality Assurance
• Design for Manufacturing