Consultant

  (610) 462-4090

  info@qualitysolutionsnow.com

A seasoned quality and regulatory professional with over 30 years of technical and compliance experience in global Medical Devices/Diagnostics, Pharmaceuticals, Combination Products, Consumer Products, Dietary Supplements and Foods industries. Strong combination of Quality Systems, Compliance, Regulatory, Clinicals, Quality Engineering, Engineering, Operations, Lean Initiatives, Product/Process Transfer & Commercialization, Contract Manufacturing, Validations, Customer Service, Project Management, Process Excellence (Black Belt certified), and acquisitions & divestitures experience. Demonstrated success in operating in stable and turnaround situations with global experience in both large company and smaller PE backed company environments.

CORE COMPETENCIES

  • Quality Systems/Auditing/Gap Analysis/Quality Maturity Modeling
  • Warning Letter Remediation
  • Regulatory Submissions
  • Design Controls/DFSS
  • Risk Management/dFMEA/pFMEA/Hazard Analysis
  • Usability Engineering
  • Complaints Management/Adverse Event Reporting
  • CAPA/NCs/Change Controls
  • Investigations/Root Cause Determinations
  • Recalls/Field Actions
  • Standard Operating Procedures/Work Instructions
  • Supplier Management/Supplier Quality
  • Training/Training Curriculum/Training Materials/Assessments/Tracking
  • Stability/Product Testing
  • eQMS Implementation/Optimization/Training
  • Process Development/Process Controls
  • Post Market Surveillance
  • Inspection Readiness
  • Project Management/Leadership
  • 21 CFR Parts 4/7/11/210/211/801/803/806/807/810/812/820/110/111/117
  • ISO 9000/ISO 13485/ISO 14971
  • EU MDR 2017/745
  • FSMA/HACCP/New Dietary Ingredient
  • Six Sigma/Certified Black Belt/DMADV

SELECTED ACCOMPLISHMENTS

  • Developed and executed a comprehensive remediation plan to revamp Quality Management Systems in response to repeat FDA inspection observations, with a specific focus on Complaints/Medical Device Reporting, CAPA, Management Responsibilities, Change Controls, Design Controls, and Risk Management.
    • Documented CAPAs for repeat observations, defined problem statements, conducted root cause investigations, and developed action plans.
    • Created optimized Complaints Management & MDR processes, including process flows, procedures, and detailed work instructions.
    • Established a robust Change Control process covering both design changes and changes not impacting product design, including a checklist for impact assessment and various supporting forms.
    • Developed a streamlined Design Controls process, including procedures for hardware and software development, detailed work instructions, and forms/templates for all design control deliverables.
    • Created a Risk Management process in compliance with ISO 14971:2019, linked to Design Controls, Complaints, Post Market Surveillance, and Operations.
  • Managed multiple workstreams to develop quality systems for compliance with EU MDR for a medical device manufacturer, including:
    • Creating and updating procedures, forms, and templates to support regulatory, clinical, design controls, risk management, post-market surveillance, quality systems, and economic operators.
    • Completing a gap assessment of technical files against EU MDR, leading to the submission of EU MDR applications for 22 product families and obtaining certifications.
    • Revamping clinical procedures, forms, and templates, and overseeing the preparation and submission of study documents for ethics approval.
  • Guided a large quality team to remediate Major Non-Conformities and critical FDA findings for a medical device manufacturer of implantable medical devices, including:
    • Revamping the CAPA process, improving complaint management, and increasing CAPA and complaint timeliness significantly.
    • Revising training programs and non-conformance procedures to capture trending and risk management effectively.
    • Registering offsite product development offices as design facilities and ensuring audit readiness.

PROFESSIONAL EXPERIENCE

  • Kendallton, LLC – President (Kendall Park, NJ) – 10/18 to Present
    Supporting numerous clients, including Intuvie LLC, Vytalogy LLC, Juvenescence, and CeQur Corporation.
  • Corin Ltd. – Chief Quality, Regulatory, and Clinical Officer – 6/19 to 7/23
  • Atrium Innovations – Chief Quality and Regulatory Officer – 10/14 to 12/18
  • Johnson & Johnson – Various positions – 1/97 to 10/14
    • Customer & Logistics Services (CLS), Sr. Director – Quality Affairs (New Brunswick, NJ) – 4/14 to 10/14
    • Consumer Products Worldwide, Sr. Director – Business Quality (Skillman, NJ) – 1/11 – 4/14
    • Orapharma Inc., Director – Quality Affairs (Warminster, PA) – 4/09 to 12/10
    • J&J Consumer, Director – Quality Affairs (Skillman, NJ) – 8/07 to 4/09
    • Veridex, Director Operations/Product Support (7/06 to 7/07)
    • Veridex, Director Customer Quality (6/03 to 7/07)
    • Ortho-Clinical Diagnostics, Acting QA Manager (Raritan, NJ) – 2/03 to 6/03
    • Ortho-Clinical Diagnostics, Staff Quality Engineer – Quality Technical Operations (Raritan, NJ) – 4/02 to 6/03
    • Ortho-Clinical Diagnostics, Staff Quality Engineer – Product Support (Raritan, NJ) – 10/01 to 4/02
    • Ortho-Clinical Diagnostics, Senior Engineer – Product Support (Raritan, NJ) – 4/99 to 10/01
    • Ortho-Clinical Diagnostics, Verification & Validation Engineer (Raritan, NJ) – 7/98 to 4/99
    • Cordis, Sr. Manufacturing Engineer (Warren, NJ) – 1/97 to 7/98
  • British Aerospace – GEC Marconi Electronics Systems – 9/93 to 1/97
  • Alpha Wire Corporation (Elizabeth, NJ) – 3/92 to 9/93
  • BF Goodrich – Simmonds Precision (Cedar Knolls, NJ) – 7/88 to 10/91

EDUCATION

  • Master of Science, Information Systems, New Jersey Institute of Technology, Newark, NJ – 9/00 to 5/05
  • Master of Science, Engineering Management, New Jersey Institute of Technology, Newark, NJ – 9/88 to 5/98
  • Bachelor of Science, Industrial Engineering, New Jersey Institute of Technology, Newark, NJ – 4/83 to 5/88

CERTIFICATION

  • Executive Quality Leadership Development (EQLD), Johnson & Johnson – 2012
  • Certified Six Sigma Black Belt (CSSGB), Johnson & Johnson – 2003

TRAINING

  • Best practices for engaging with the US FDA on HFE strategy and submissions, Emergo – 2024
  • Conducting a Comparative Analysis in Lieu of HF Validation Testing, Emergo – 2024
  • Medical Device Software and Cybersecurity, Emergo – 2024
  • Proposed Rule Medical Devices; Quality System Regulation Amendments 21 CFR 820 – 2023
  • MHRA, UK Road Map and Swiss Regulatory Updates, Emergo – 2023
  • Claiming Equivalence Under MDR – Regulatory Considerations, BSI – 2022
  • Understanding Risk Management with Medical Devices, FDA – 2022
  • MDR Rule 14 Devices (Combination Products), BSI – 2021
  • Clinical Evaluation for Medical Software & AI Devices, BSI – 2021
  • UKCA for Medical Devices, BSI – 2021
  • European Union Medical Device Regulation (EU MDR), TUV Sud – 2019 & 2020
  • ISO 14971:2019, TUV Sud – 2020
  • Extension to the MDR Transition Timelines – 2020
  • Executive Quality Leadership Development (EQLD) –2012
  • Crossing the Finish Line, Diversity and Inclusion Group, New Brunswick, NJ – 2010
  • Project Management, Ortho-Clinical Diagnostics, Raritan, NJ – 2001
  • 7 Habits of Highly Effective People; Learning Services, J&J Corp.- 2007
  • Kepner Traego – Problem Solving Techniques; Learning Services, J&J Corp. – 2006
  • Seven Steps to Finding Root Cause; ADVAMED – 2006
  • Failure Modes and Effects Analysis (FMEA); Learning Services, J&J Corp. – 2008
  • Design for Manufacturability/Concurrent Engineering; GEC Marconi, Wayne, NJ – 1997