Consultant

  (610) 462-4090

  info@qualitysolutionsnow.com

Excellent track record of over 20 years effective implementation and maintenance of Quality Systems and compliance programs for ISO 13485, ISO 9001, ISO 17025, 21 CFR 820, 21 CFR 210, and 21 CFR 211. Various industries: Med Device (Class I/II/III), Plastic Injection Molding, Combination Drug Products, OTC Monograph Drug Products. Background in combination medical device + drug component, OTC Monograph drug products, wound care, single-use consumables for biopharma industry, tube sets, silicone injection molding, bone putty, MG-UHMW, medical device assembly, contract manufacturing, adhesives and wound dressings, defibrillator electrodes, grounding pads, TENS electrodes, rubber transfer molding, plastic blow molding, companion diagnostic kit, polymers, convenience kits, endoscopic accessories, electronic printed circuit boards, EO/EtO sterilization, gamma sterilization, and E-Beam sterilization.

CORE COMPETENCIES

  • New Product Development
  • Technical writing (510Ks, SOPs, validations)
  • Design (Design Reviews, Design Transfer)
  • Development of processes
  • Risk Management/FMEA/Hazard Analysis
  • Process Development/Process Controls
  • Post-Market Surveillance
  • Change Controls
  • Labeling/Marketing Literature SME
  • Quality Systems development/Auditing
  • Statistical analysis
  • Customer/Supplier interface
  • Developing training materials and training personnel
  • Process/Product/Software validation
  • Computer Systems (ERP, Microsoft Office)
  • ISO 13485/9001/17025
  • FDA/ISO/EU MDR/MDSAP

SELECTED ACCOMPLISHMENTS

  • FDA Inspections resulting in 483/Warning letter with complete remediation to clear issues with FDA.
  • 510K and PMA submissions to bring products to US market.
  • Upgraded systems to meet EU Medical Device Regulations (MDR).
  • Implemented eQMS systems (EnterpriseIQ-4 facilities, Greenlight Guru-2 facilities) to streamline quality systems to improve FDA inspections and ISO audits.
  • Established new Quality Policy to reduce customer complaints from 17 per month to less than 2 per month.
  • Conducted mock PMA inspection to prepare facility for successful FDA PMA inspection.
  • Conducted recall activities for two OTC Monograph drug products to remove from the market.
  • Conducted recall activities for medical device in Japanese market.
  • Completed design files for combination medical device + drug product.
  • Performed risk analysis and updated risk files for medical device + drug product, endoscopic accessories, defibrillator electrodes.
  • Lead site to implement 5S Lean Manufacturing.
  • Developed technical files/design dossiers for over 20 medical devices for European market.
  • Planned and qualified new Class 8 cleanroom.
  • Identified and qualified new contract manufacturing organization (CMO) for combination product.

PROFESSIONAL EXPERIENCE

  • Omeza – Director of Quality/Regulatory, 3/2023 to 12/2024
  • WHK Biosystems – Director of Quality, 4/2022 to 1/2023
  • National Molding – Quality/Regulatory Manager, 11/2019 to 4/2022
  • Scapa – Quality/Regulatory Manager, 3/2018 to 11/20219
  • Katecho – Director of Quality/Regulatory, 6/2016 to 1/2018
  • MedPlast – Quality/Regulatory Manager, 8/2014 to 6/2016
  • Myriad Genetics – Quality/Regulatory Consultant, 5/2014 to 8/2014
  • Biomerics – Quality/Regulatory Manager, 11/2010 to 5/2014
  • Integra Life Sciences – Quality/Regulatory Manager, 11/2009 to 10/2010
  • Hobbs Medical – Director of Quality/Regulatory, 10/2007 to 11/2009

EDUCATION

Bachelor of Science, Biology, Boise State University, 5/2007

CERTIFICATION

ISO 9001 Registered Auditor/Lead Auditor Training, Stat-A-Matrix, 6/2000

TRAINING

  • ISO 14971, BSI, 11/2007
  • Overview of CE Marking, BSI, 2/2008
  • Overview of CMDR and CMDCAS, BSI, 2008
  • Overview of ISO 13485, BSI, 2008
  • Essentials of ISO 13485, BSI, 2/2010
  • ISO 14971 Compliance Clinic, BioUtah, 4/2013
  • Root Cause Analysis, BSI, 2014
  • Aseptic Water Sampling Technique, 2015
  • Internal Auditing ISO 13485, Medplast, 10/2015
  • ISO 13485/9001 Transition Training, Axeon, 8/2018
  • Leadership Series, Vermont Tech, 2021-2022
  • Dale Carnegie Course, Tampa, FL, 2021
  • ISO 17025 Implementation Training, Axeon, 12/2022
  • EU Medical Device Regulation (MDR), Greenlight Guru, 2024-2025
  • Medical Device Single Audit Program (MDSAP), BSI, 2025

AFFILIATIONS

  • Parenteral Drug Association (PDA) – Jan 2022
  • American Society for Quality (ASQ)