Experience

• 

  RQM+

  • Monroeville, PA

  • Principal/Auditor

    • Feb 2019 - Present
    • Monroeville, PA

    Senior Consultant working with medical device manufacturers to achieve and maintain compliance with the regulatory requirements of the EU MDR, EU IVDR, clinical evaluation planning and reporting, performance evaluation and quality management system certifications including ISO 13485:2016, 21 CFR 820, and MDSAP.

• 

  TUV Rheinland North America

  • Newtown, CT

  • Lead Auditor - Medical

    • Sep 2011 - Feb 2019
    • Newtown, CT

    Audit medical device manufacturers for compliance with international regulatory requirements and standards, including the European Union Medical Devices Directive, IVDD CMDCAS, and MDSAP. Audit quality management systems for compliance with ISO 13485. Product expert for non-active medical devices in the areas of sterilization, biocompatibility, clean room technology, and clinical evaluation.

• 

  Nerac, Inc.

  • Tolland, CT

  • Analyst/Project Manager

    • Jan 2002 - Jul 2015
    • Tolland, CT

    Research consultant working closely with medical device companies to support research & development, new product introduction, market & technology assessments and regulatory compliance. Areas of Expertise Medical Device Development and TechnologiesCombination Products Quality Assurance - EN ISO 13485Regulatory Compliance - FDA, European Union, CanadaSterilization Techniques & Validation Infectious DiseasesMicrobiology

• 

  Naugatuck Valley Community College

  • Waterbury, CT

  • Adjunct Professor - Microbiology

    • 2001 - May 2015
    • Waterbury, CT

    Adjunct Professor of Microbiology

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  ACMI

  • Quality Manager

    • 1994 - 2001

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  US Surgical Corp

  • Sterilization

    • 1992 - 1993