Dan Mahaffey

Background

About Dan Mahaffey

Certifications- •RABAQS/ IRCA: Certified Lead Auditor for ISO 9001/ISO 13485 •APICS: Certified Supply Chain Professional (CSCP) •Health Canada: CMDCAS Certified Auditor ISO 13485 •American Society for Quality (ASQ): Certified Biomedical Auditor (CBA) •Regulatory Affairs Professional Society (RAPS): Regulatory Affairs Certification (RAC)(US) •American Association of Tissue Banks (AATB): Tissue Bank Internal Auditor •American Association of Tissue Banks (AATB): Certified Tissue Banking Specialist (CTBS) Areas of Expertise- •ISO 9001 •21 CFR 1271/ AATB Standards •ISO 13485 •FDA QSR/cGMP (21 CFR 11,803,806,210,211,820) •CMDCAS (Canadian Medical Device Regulation) •EC Medical Device Directive 93/42/EEC and 90/385/EEC (AIMD) •Good Clinical Practices/ ISO 14155 •ISO 14971 Special Skills and Honors- •Presenter and speaker at AATB and ASQ events and conferences •Assisted in the International Society of Pharmaceutical Engineers (ISPE) educational program rewrite as a Compliance expert •Assisted in review and re-write of the 2009 ASQ Certified Biomedical Auditor exam •Voting Member of the AATB Standards Committee •Participation on multiple AATB task forces including Electronic Records, QSR Harmonization and Internal Auditor Training Course development. •Fluent in Spanish and conversational Russian •Inducted into the Golden Key International Honor’s Society •Selected to compete in the Phi Beta Lambda Arkansas State Business competition •Expert computer and network skills. Proficient in MS Office programs. •Received the bronze medal in the Oklahoma State Russian essay competition. •Experience living and working outside of the United States (Mexico, Russia) Industries with Certified Technical Competency- •Machining- CNC Lathe and Mill •Electronics Manufacture and Assembly •Printed Circuit Board Manufacture •Semiconductor and Chip Manufacture •Plastics Injection Molding •Casting/ Forging/ Forming •Chemical Mixing, Treatment •Warehousing and Distribution