Manfred Walder

About Manfred Walder

As an accomplished leader in Quality Management System design, development and implementation, my primary focus is the continual enhancement of system solutions which align with the ever-changing regulatory, industry and customer requirements and enable teams to improve efficiency. My expertise includes regulatory, ISO and industry standards in the Medical Device, Automotive and Aerospace industries as well as advanced business process modeling. With my extensive knowledge of developing systems within life cycles for product development, supplier management and quality processes, I am able to deliver solutions which are easy to use and highly integrated. • Quality System Strategies• Implement Quality Systems• Training Strategy • Project Management• New Product Development• Leadership of Cross-functional teams

Experience

1. VP of Operations

   Novunex

   Oct 2017 — Present · Bend, OR, US

Education

• British Standards Institution (BSI)

  ISO13485 Lead Auditor

  2009 — 2009

• HTBLuVA Klagenfurt

  BS

  1983 — 1988

• American Society for Quality

  Certified Quality Engineer (CQE)

  2008 — 2008

Skills

• Test Development
• Quality System Strategies
• System Deployment
• Ts16949
• New Product Implementations
• Project Planning
• Lean Manufacturing
• Software Systems
• Quality Training
• Change Management
• Kaizen
• Risk Management
• Six Sigma
• Electronics Manufacturing
• Project Management
• Spc
• IT Solutions
• Continuous Improvement
• Iso 13485
• Cross-Functional Team Leadership
• Supplier Quality
• Root Cause Analysis
• Iso
• Quality System
• Fda
• Tqm
• Medical Devices
• Document Management
• Capa
• As9100
• Quality Excellence
• Fda Qsr
• User Interface Specifications
• Smt
• Value Stream Mapping
• Iso Standards
• Failure Mode and Effects Analysis (Fmea)
• Team Building
• Design for Manufacturing
• Quality Assurance