Ken Bigley

About Ken Bigley

I am a certified PMP, and a certified ISO 9001 3rd party auditor. I have a diverse background which enhances my project management and people management abilities. I am an established goals oriented professional, with superb interpersonal skills. I have been a Quality Manager with mutiple companies over the last 20 years. Proven areas of experience include: Auditing, Project management, Quality Management, Documentation Control, Pharmaceutical / Pharmacy automation manufacturing, Supplier quality / improvement, Manufacturing process and procedure improvement (Toyota Mfg system), Lean / six sigma, Process auditing, Project implementation, Change management, Risk analysis, and Vendor management. Specialties: Project management, risk management, quality assurance, vendor management, change management, process improvement, training, and continuous improvement. Thorough understanding of regulatory requirements – ISO9001, ISO14001, AS9100, & UL.

Experience

1. External Auditor

   Intertek

   May 2017 — Present · Based in Raleigh, NC

   Part-time third-party ISO 9001 auditor with Intertek.(Only working about 5 days a month - Hunting and fishing the rest of the time).

Education

• Columbus State Community College

  Asso

  1971 — 1973

• The Ohio State University

  BS

  1979 — 1981

Skills

• Testing
• Fmea
• Spc
• As9100
• Pmp
• 5s
• Root Cause Analysis
• Dmaic
• Jit
• Electronics
• Engineering
• Manufacturing
• Operational Excellence
• Ts16949
• Tl9000
• Project Management
• Poka Yoke
• Supplier Quality
• Iso 14001
• Training
• Process Improvement
• Quality Assurance
• Corrective Actions
• Lean Manufacturing
• Minitab
• Gage R
• 8d Problem Solving
• Vendor Management
• Software Documentation
• Change Management
• Quality Management
• Value Stream Mapping
• Process Capability
• Risk Management
• Quality Control
• Iso
• Continuous Improvement
• Iso 9000
• Quality Auditing
• Electronics Manufacturing