Robert J. Hahn

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Senior Quality Consultant

Robert has more than 30 years of experience in quality assurance, regulatory compliance, process engineering, and manufacturing in the medical device industry. He has a proven success in the Medical Products industry with developing, redesigning and managing cost effective Quality Systems that are successful in an increasingly rigorous and global regulatory environment. Demonstrated success in implementing change to resolve complex compliance and business issues. Proven experience in many aspects of design and manufacturing has given Robert a unique understanding of challenges across the medical products business.


  • Planned and conducted compliance audits for a variety of Class 3 and Class 2 products ranging from implantable electromechanical devices, single use disposables, tissue products, combination products and biologics.
  • Knowledge and experience in auditing for compliance to US QSR/ CGMP ISO 13485, Canada CMDR SOR/98-282, Japanese PAL, ISO 9000.
  • Experience as program manager in leading product development business process re-engineering efforts from concept to manufacturing transfer including integration of Design Controls.
  • Implemented re-engineered multi-site Purchasing Controls system with supplier control requirements designed around product and component risk analysis
  • Participated in a 4 month Design Controls system analysis project that resulted in significant risk management system improvement recommendations which were accepted for integration into the business processes
  • Conducted complaint file remediation project to integrate product Risk Management into complaint review and subsequent action
  • Instrumental in leading efforts that successfully resolved Regulatory compliance issues including Warning Letters and a Consent Decree with US FDA.
  • Developed and delivered Quality Training in response to compliance deficiencies and to support Corporate Quality initiatives.
  • Led cross functional a team that established common quality metrics across 7 business units and 2 geographic areas.
  • Developed best practices guidance for Due Diligence evaluations and for integration of quality systems for new acquisitions.
  • Revised audit process which resulted in a 40% reduction in procedures, provided a comprehensive business sector compliance evaluation every 2 years, and reduced travel expense by 25%.
  • Led use of a consistent audit record database for multiple sites that reduced record keeping costs and improved analysis of audit data across the corporation.
  • Established internal audit process and trained auditors in Japanese operations to meet Japanese Pharmaceutical Affairs Law.
  • Implemented Program Management systems and tools that increased on-time completion of development project milestones.
  • Led project to redesign of interconnects for implantable device components which reduced cost by approximately $25 million over the product lifecycle with equal or improved reliability using enhanced design and process FTA and FMECA tools.
  • Co-chair for division Six-Sigma implementation plan which resulted in component cost reductions of approximately 10% per year over 3 years with reduction in product returns.
  • Management responsibility for Configuration Management/ Records function. Responsible for transition from paper to Documentum and E-Matrix systems
  • Implemented systems to enhance outgoing quality in 5 manufacturing areas reducing customer return DPM by over 90%.
  • Operations manager for manufacturing of proprietary biomedical electrodes and wound care products.
  • Led teams to perform Quality System audits at multiple facilities worldwide to US and OUS requirements.
  • Established system for Parametric Release of Ethylene Oxide sterilized products resulting in 50% reduction in product cycle times through manufacturing.
  • Designed, developed, and validated sterilization processes using ETO, Steam, Radiation and Aseptic processes.
  • Senior Quality Consultant – BioTeknica, Inc.
  • Interim Quality Systems Director – Medtronic Physio Control
  • Sr. Manager Corporate Audit – Medtronic Corporate Quality
  • Sr. Program Manager – Medtronic Cardiac Rhythm Management
  • Director Quality Assurance – Medtronic Energy and Component Center
  • Operations Manager – Medtronic Promeon Medical
  • Compliance Specialist – Medtronic Cardiac Rhythm Management
  • Engineering Supervisor – Medtronic Cardiac Rhythm Management
  • Sterilization Microbiologist/Process Engineering – Medtronic Cardiac Rhythm Management
  • Mini-Masters in Quality Management – University of St. Thomas
  • Microbiology Major – University of Minnesota
  • ASQ Certified Biomedical Auditor
  • ASQ Certified Quality Auditor