Dan Tokheim has extensive experience as a quality engineer in both contract manufacturing and OEM environments, from industrial products to class III medical devices and pharmaceuticals (including combo's). He holds an ASQ certification as a CQE (Certified Quality Engineer).
He has proven experience in all of the following areas:
· Risk Management: FMEA, PFMEA
· Supplier development and verification of purchased product
· Capability analysis
· Gage R & R
· Custom gage development
· Gage calibration
· Control plan development (including HACCP plans)
· Statistical Process Control (SPC)
· Process validation (IQ, OQ, PQ)
· Process auditing, supplier development, and verification of purchased product
· Cleanroom validation and ongoing monitoring
· Temperature mapping
· Continuous improvement, Kaizen, Value Stream Map (Lean)
· Six Sigma problem solving (DMAIC)
· Packaging qualification
· Sterilization (ETO & Gamma)
· Control and analysis of non-conforming product
· CAPA and Verification of Effectiveness
· Pest control
· Post market/complaint reporting