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  Diane Kulisek, Founder and President of

  • QA Superpowers:  Quality Assurance Leadership, Quality Management Systems (QMS), Metrics, Cost of Quality (UnQuality), Corrective and Preventive Action (CAPA)
  • Medical Devices, Aerospace, Consumer Products, Filtration, Plastics, Metal Fabrication, Electronics, Assembly, Packaging.
  • MS Engineering, BA Biology, Grad. Cert. Program Management, American Society for Quality Certified Manager of Quality/Organizational Excellence, Quality Engineer (ASQ CMQ/OE, ASQ QE), Lean Six Sigma Green Belt (LSSGB) Institute of Certified Professional Managers Certiifed Manager (ICPM CM). 
  • To learn more about Diane and for free examples of her work (including templates)CLICK HERE.


  Mike Dempsey, QA Team Member

  • QA Superpowers:  Corrective & Preventive Action, Problem Solving & Root Cause Analysis, Quality Auditing, Process and Analytical Method Validation, Quality Management System Leadership
  • Pharmaceuticals, Active Pharmaceutical Ingredients and Excipients Manufacturing, Process Analysis, cGMP Audits of Facilities and Processes, International Regulations
  • BS Chemistry, American Society for Quality Certifiied Quality Engineer, Quality Auditor, Biomedical Auditor and Manager of Quality/Organizational Excellence (CQE, CQA, CBA, CMQ/OE), Registrar Accreditation Board Quality System Auditor (RABQSA)
  • To learn more about Mike, CLICK HERE.  


 Christine Hardee, QA Team Member and Virtual QMS Auditor 

  • QA Superpowers:  All things having to do with QA Documents and Records, Auditing, Understanding Third Party Requirements
  • Medical Devices, Pharmaceuticals, FDA-regulated Industry
  • American Society for Quality Certified Quality Auditor (ASQ CQA) for 21 CFR 10, 21 CFR 11, 21 CFR 820, ISO 13485:2003, ISO 9001, MDD 93/42.  In process quality control, document control, procedure writing, calibration verification, internal audits, lead interface for third party audits.  
  • To learn more about Christine, CLICK HERE.   

Steve Jerger, QA/QC/RA Team Member

  • QA Superpowers:   Quality Assurance Leadership, Corrective and Preventive Action (CAPA), Problem Solving & Root Cause Analysis
  • Medical Devices, Pharmaceuticals, Biotech and other FDA-regulated Industries, Multi-Site Manufacturing Operations, Start-Ups, Injection Molding, Electronic Assembly
  • BS Chemistry
  • 21 CFR 10/11, 21 CFR 820, ISO 13485, SOP Development, Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), Risk Assessment, Batch Processing, Product Release, Verification & Validation Protocols and Reports, Cleaning Operations, Hosting FDA Inspections, Supplier Qualification, Quality Agreement Negotiations, API Stability Monitoring
  • To learn more about Steve, CLICK HERE

  T. M. Kubiak, Author, QA/OE Team Member

  • QA Superpowers:   Lean Six Sigma Continuous Improvement Deployment, Metrics and Process Design
  • Aerospace, Retail, Financial Sector (Banking)
  • PhD (Coursework), MS and BS Industrial Engineering
  • American Society for Quality (ASQ) Fellow, ASQ Certified Manager of Quality/Organizational Excellence (CQM/OE), Six Sigma Black Belt (CSSBB), Quality Engineer (CQE), Reliability Engineer (CRE), Institute of Industrial Engineers (IIE) Certified Systems Integrator, Society of Logistics Engineers (SOLE) Certified Professional Logistician, State of Florida Professional Engineer
  • To learn more about T. M. Kubiak, CLICK HERE and HERE.