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Quality Engineering

  

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

 

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