Consultant

  (610) 462-4090

  info@qualitysolutionsnow.com

Professional consultant having executive experience, with expertise as lead or principle certified auditor responsible for audit planning, scheduling, conducting, and reporting for numerous ISO 9001, ISO 14001, ISO 13485, and OHSAS 18001 management systems. Highly credentialed with over 10 years of hands-on auditing experience working with medical device manufacturers, including process validation and equivalency studies for process risk assessment according to ISO 14971. Background in general medical and dental implants, quick brain drills, orthopedic tools (reamers, taps, and quick drills), and heart pump implants.

CORE COMPETENCIES

  • Precertification Audits ISO 13485
  • ISO Audits ISO 14971
  • Gap Analysis ISO 9000
  • Internal Audits Council Directive 93/42/EEC (MDD)
  • External/Supplier Audits Directive 98/79/EC (IVDD)
  • Product/Process Audits Directive 90/385/EEC (AIMD)
  • Design History File Audits SOR/98-282
  • Technical File Review ISO 14001
  • 510 (K) Review OHSAS 18001
  • Design Dossier Review Quality Management Systems
  • 21 CFR Part 820 Regulatory/Quality/Compliance Management

SELECTED ACCOMPLISHMENTS

  • Conducted ISO and OHSAS audits for many medical device manufacturers to include audit planning, scheduling, and reporting related to ISO 9001, ISO 13485, ISO 14001, and OHSAS 18001
  • Maintained and implemented latest regulation changes, as well as updates for any ISO/OHSAS, or environmental management systems for clients as lead consultant
  • Maintained quality management systems for numerous manufacturing companies in the medical device industry
  • Consulted with many medical device/equipment companies to ensure that proper process validation and equivalency studies in place for process risk assessment according to ISO 14971
  • Audited various clients as a subcontractor auditor for certifying bodies, including Global Registrar’s, The Registrar Company, BSI, and TUV for ISO 9001, ISO 13485, and ISO 14001
  • Performed regulatory audits for products per European Medical Device Directives (AIMD, MDD, AND IVDD), FDA, and CMDCAS as requirements
  • Completed 510 (K) FDA file reviews, design dossier reviews (EU Directive), and technical file reviews (EU Directive)

PROFESSIONAL EXPERIENCE

  • Global ISO Auditing, Founder, Lead Auditor, January 2003 – Present
  • Richter Precision Inc., Corporate Quality and Safety Manager, May 2007 – Present
  • Amino North American Corporation, Plant Manager, June 2002 – May 2007
  • General Motors, Supplier Quality Engineer, June 2000 – June 2002

EDUCATION

  • BS, Industrial Production Engineering, University of Mysore, 1995

CERTIFICATION

  • RABQSA Certified Internal Lead Auditor, TS 16949
  • RABQSA Certified 3rd Party Lead Auditor for Quality Management System, Scope ISO 9001/ISO 13485
  • RABQSA Certified 3rd Party Lead Auditor for Environmental Management System, Scope ISO 14001/EMS Compliance/Environmental Planning
  • RABQSA Certified 3rd Party Principle Auditor for Occupational Health and Safety, OHSAS 18001
  • Licensed Professional Engineer, Ontario Canada

TRAINING

  • Corrective and Preventive Action, Chrysler Supplier Development
  • APQP, General Motors University
  • PAPP, General Motors University
  • Certified Lead Auditor, 2nd Party, ISO 13485:2003
  • General Industry Safety and Health, Labor Department
  • RABQSA Competency for OHSAS 18001