Consultant

  (610) 462-4090

  info@qualitysolutionsnow.com

Professional with technical and compliance knowledge, skilled in regulatory affairs, quality assurance, operations, and engineering. Highly credentialed with over thirty years of experience working for top global medical device manufacturers. Background in surgical stapling, sutures, point of care testing, orthopedic implants and human tissue.

CORE COMPETENCIES

  • 21 CFR Part 820/803
  • Operations Management
  • 510(k) Submittals
  • Six Sigma Training/Lean Manufacturing
  • Process Development/Process Controls
  • Project Management
  • Quality System Development/Support/Auditing
  • Operating Procedures/Work Instructions
  • Regulatory Affairs
  • ISO 9001/ISO13485/ISO14971
  • Corrective & Preventive Action
  • Process Improvement
  • Engineering Change Notices/Change Orders
  • Class II Medical Devices

SELECTED ACCOMPLISHMENTS

  • Development of a Quality System for medical device manufacturers of orthopaedic implants, including:
    • Wrote standard operating procedures and implemented the quality system and achieved ISO 13485 registration
    • Conducted management reviews and implemented quality metrics
    • Developed complaint management and tracking process
    • Conducted internal & vendor audits
    • Managed Material Review Board and CAPA processes to address nonconformance and address deficiencies in a timely manner
    • Managed contract manufacturers to achieve business goals through adherence to specification, quality agreements and on-site visits
    • Implemented risk management process, which also included post-market surveillance
    • Developed Quality System for two small start-up medical device companies
  • Facilitated and managed various projects for medical device manufacturers of products in orthopaedics and powered stapling devices, including:
    • 510(k) submissions coordination for multiple products, which all received clearance to market per 21 CFR Part 807
    • Completed establishment registrations, device listing according to 21CFR Part 807
    • Coordinated biocompatibility, toxicology, Eto residual, cleaning validation, sterilization and packaging validations in support of 510(k) submissions
    • Wrote protocols, supported testing and completion reports to support design verification and validation activities for sutures, surgical staplers, and orthopaedic devices in simulated bench top and cadaver testing
    • Achieved CE Mark for products through Technical File development and maintenance
    • Ensured Design History Files met the requirements of the regulations
  • Managed various projects in support of operations improvement for medical device manufacturer of suture products and point of care testing devices, including:
    • Served as project leader for manufacturing location and core team member for multi-site implementation for lean initiatives resulting in multi-million dollar savings for the company
    • Served as project leader for new product development launch
    • Conducted root-cause investigations
    • Developed and implemented Supplier Excellence Program, which included utilization of six-sigma tools leading to dock-to stock for multiple purchased components
    • Acted as project leader for root-cause investigation using the DMIAC process for a major point-of-care device, resulting in over $350K in annual savings
    • Qualified environmental monitoring system to maintain compliance to ISO standard Class 8
    • Managed procuring $20 million in raw material for chemicals and process components
    • Established and coordinated all training for the unionized Somerville Plant manufacturing operations
    • Supported development and approval of union contracts
    • Reduced cycle time for two departments by 20%
    • Implemented MRP Class A initiatives
    • Developed and implemented critical zone strategy for packaging suppliers, which included Control Plan and FMEAs
    • Ensured facility maintained regulatory compliance with respect to state, federal and international regulatory agencies FDA QSR, EN460001, ISO13485 and ISO9001
    • Utilized TrackWise for CAPAs, audits and non-conformances management

PROFESSIONAL EXPERIENCE

  • L C Morgan Consulting, Owner (Yardley, PA) – 5/10 to Present
  • Alku Technologies, Consultant (Andover, MA) – 10/12 to Present
  • Core Essence Orthopaedics, RA/QA Manager (Langhorne, Ft. Washington, PA), – 12/09 to 5/10
  • International Technidyne Corporation, Operations Director, (Edison, NJ) – 5/10 to 5/12
  • Power Medical Interventions, (Langhorne, PA), Operations/QA/Regulatory Management – 9/04 to 12/09
  • Johnson & Johnson Ethicon, Inc, Engineering and Operations Management, (Bridgewater, NJ and Cornelia, GA) – 9/89 to 9/04
  • Johnson & Johnson Ethicon, Inc, Engineering, (Bridgewater, NJ) – 9/79 to 9/04

EDUCATION

  • Masters of Business Administration, Marketing, University of Phoenix – 9/01 to 8/04
  • BSIE, New Jersey Institute of Technology – 9/76 to 12/81

CERTIFICATION

  • Logistics Certification – Georgia Institute of Technology
  • Six Sigma Green Belt Certified
  • Medical Device Certificate Program, RAPS

TRAINING

  • Quality Systems Regulations
  • Design of Experiments, Measurement Systems Analysis, Risk Management, STAT-A-MATRIX
  • ISO: 9000 and ISO: 13485 Internal Auditing, Power Medical Interventions and International Technidyne Corporation
  • Six-Sigma Black Belt trained, Green Belt Certified, Johnson & Johnson
  • Supply Base Management, Saddle Island Institute
  • Process Validation, Medical Design & Manufacturing Conference Training
  • Advanced Good Manufacturing Practices, Medical Design & Manufacturing Conference Training
  • Risk Management, Medical Design & Manufacturing Conference Training
  • Corrective and Preventive Action, Medical Design & Manufacturing Conference Training
  • Lean, Johnson & Johnson
  • Kaizen, Johnson & Johnson
  • 5S, Johnson & Johnson
  • Value Stream Mapping
  • Human Tissue Regulations, LifeCell™ Corporation

AFFILIATIONS

  • Regulatory Society Professional Society (RAPS)
  • American Society of Quality (ASQ)