May 25, 2015 Gurus Currently Available: • Joanne Mayo • Jim Murrell • Mary Chris Easterly • Haleh Byrne • Joe Knight-McKenna • Frank Golden • Mike Nichols See details below about each Guru…. Name: Joanne Mayo Organization: Laird Title: Quality Assurance Manager Email: jomayo@nc.rr.com Area of Expertise: Manufacturing, Human Resources, ISO/TL 9000 Quality Management Systems, Malcolm Baldrige, Sarbanes Oxley, URAC and ACHC Healthcare accreditations Industries: Computers, Telecommunications, Pharmacy, Thermoelectric Education/Degrees: Bachelor of Science - Management Information Systems ASQ Certifications: Certified Quality Auditor (CQA) Certified Manager Quality/Operational Excellence (CMQ/OE) Certified Six Sigma Green Belt (CSSGB) Professional Associations: RAB/QSA Registered Quality Systems Lead Auditor RAB/QSA Skills Examiner Malcolm Baldrige National Quality Award (MBNQA), Examiner 2002 & 2003, Society for Human Resource Management; HR Certification Institute: SPHR (Senior Professional Human Resources) certification North Carolina Awards for Excellence (NCAfE) Advisory Council Additional information: ASQ Fellow ASQ Board of Directors 2011-2013 ASQ Region 11B Deputy Regional Director (2008-current) ASQ Raleigh 1113 Chair 2014 ASQ Raleigh 1113 Mentor Chair (2009-current) Name: Jim Murrell Title: Quality/Operations Management Email: Jmurrell.asq@usa.net Area of Expertise: Electronics Manufacturing Services (EMS)/Aerospace-Quality & Operations Management Industries: EMS/Aerospace (Manufacturing & Service) Education/Degrees: BBA (Texas Tech); Industrial Management & Engineering ASQ Certifications: Certified Manager of Quality/Organizational Excellence Professional Associations: ASQ Additional information: Six Sigma Lean Green Belt Certified Certification in Demand Flow Technology & Dimensional Metrology Quality Texas Examiner-Baldrige Performance Excellence Program (MBNQA) Proven executive with a record of achievement building highly effective management teams. Experienced in process improvement activities using Six Sigma Lean techniques. Performed strategic planning to produce superior quality products at the lowest possible cost. Name: Mary Chris Easterly Organization: Merck Title: Senior Specialist, Quality Systems & Compliance Email: mary.chris.easterly@merck.com Area of Expertise: Auditing – internal, supplier, and client audits and regulatory agency inspections GMP compliance, Quality Assurance roles, training Industries: Medical device and pharmaceutical manufacturing Education/Degrees: BS Industrial Engineering, Virginia Polytechnic Institute & State University; MS Quality Assurance, California State University @ Dominguez Hills ASQ Certifications: CQA, CMQ/OE, Certified Pharmaceutical GMP Professional Professional Associations: ASQ Additional information: Audit Division Treasurer Trainer at annual ASQ Audit Division Conference: Writing Exceptional Audit Reports (2-day seminar) ASQ Divisions: Audit; Food, Drug & Cosmetic; Customer Supplier Participate in developing and reviewing Certified Pharmaceutical GMP Professional exam and handbook writing Reviewed ASQ Auditing Handbook and Biomedical Auditor Handbook Name: Haleh S. Byrne Organization: NCSU - IES Title: Lead Industrial Engineer – Lean Improvement Specialist Email: Haleh_byrne@ncsu.com Area of Expertise: Simulation (s8), LEAN SIX SIGMA, SPC, MSA, FMEA, Time Study & Work Measurement(TIMER PRO), Costing, Layouts Industries: Manufacturing, Processing, Office, Healthcare Education/Degrees: BS in IE from NCSU ASQ Certifications: CQE Professional Associations: Institute of Industrial Engineers (IIE) – Lean Division Board Director Institute of Industrial Engineers (IIE) – Society of Engineering & Management Systems (SEMS) Board DirectorSociety of Manufacturing Engineers –(SME) Member – Lean bronze certified ASQ member Name: Joe Knight-McKenna Organization: Quintiles Title: Associate Director, Quality Management, Lifecycle Safety Email: jknightmckenna@triad.rr.com Area of Expertise: Compliance with FDA and International Regulations, Business Continuity Industries: Pharmaceuticals, Medical Devices, Healthcare Education/Degrees: BS Nursing, MBA, Certificate of Advance Graduate Studies-Healthcare Management ASQ Certifications: CQA CBA CHA CQE CSQE CMQ/OE, CSSBB, CPGP Regulatory Affairs Professional Society (RAPS), Drug Information Association (DIA), North Carolina Regulatory Affairs Forum (NCRAF), Continuity Planners Association of the Carolinas (CPAC), Business Continuity Institute (BCI), and membership in the following ASQ divisions -Audit Division, Biomedical Division, Food Drug & Cosmetic Division, Health Care Division Professional Associations: Additional information: Project Management Institute Certification: Project Management Professional and Risk Management Professional. I have combined my quality experience with Regulatory Affairs Certifications (RAC) for the US, EU, CAN and GS. I would like to mentor new members in the areas of regulatory compliance and how they can combine quality and regulatory affairs to be a great resource for their company. Name: Frank Golden Organization: Self Employed Title: Supplier Qualification Consultant and ISO 13485 and 9001 Auditor Email: fjgolden@aol.com Area of Expertise: Supplier Quality Management, Pharmaceutical GMP Compliance, Auditing, Lean Management, Six Sigma Industries: Pharmaceutical, Medical Device Education/Degrees: AAS Biological Technology, BS Biology, MBA ASQ Certifications: CQA, SSBB Professional Associations: ASQ Additional information: ASQ 11B Regional Director Name: Mike Nichols Organization: tactegra Title: Senior Consultant, MBB Email: Mike@Nicholsqualityassociates.com Area of Expertise: Lean Six Sigma, Business Process Management Industries: Financial, transportation, service and transactional Education/Degrees: BBA Finance, MSE Industrial Systems Engineering ASQ Certifications: CQE, CQA, CQMOE, SSBB Professional Associations: ASQ, ISQ Additional information: Certified MBB at American Express 2006. After almost 20 years of continuous volunteer service at the local and national level Mike was elected President of the American Society for Quality member year 2007/08. During his tenure he led the development and adoption of the ASQ global strategy. This strategy has provided for significant growth in the membership services and activities around the world including the establishment national service centers in Mexico City and Delhi. As president in addition to leading multiple committees he was actively engaged in board meeting planning, society budgeting and member leader development. He has published two books on Six Sigma and Process Management. His strengths are in the development, deployment and implementation of these methodologies. Name: Organization: Title: Email: Area of Expertise: Industries: Education/Degrees: ASQ Certifications: Professional Associations: Additional information: