Enabling Business Success through Quality System Control and Regulatory Compliance for the Medical Device Industry
Ron is a dedicated, well-organized, quality professional with vast experience in product, process and quality engineering, auditing, product development and commercialization, regulatory compliance, production supervision, and quality management systems development and support.
Multi-faceted with thirty-five years of experience in world-class medical device and biotech manufacturing operations, Ron’s professional background includes work experience in the areas of in-vitro diagnostic medical devices, digital imaging equipment, interventional devices, bio-based materials, and bio-polymer devices and delivery systems.
He has served in key professional roles, such as, product development engineer, process engineer, systems support engineer, quality assurance and production supervisor, product quality management engineer, plant quality assurance manager, global quality manager, and director of quality management systems.
Ron has made significant contributions during his employment at E.I. DuPont de Nemours & Co., Dade Behring, Inc. (purchased by Siemens Medical Solutions in 2007), W. L. Gore and Associates, Hologic Inc., and Actamax Surgical Materials, LLC. His accomplishments include overseeing the implementation of a Total Product Quality Management System for the DuPont Diagnostics manufacturing organization, the establishment and certification of several quality management systems to ISO 9001, ISO 13485 and ISO 14971, and the qualification of several contract manufacturing organizations. Through the application of statistical process controls and methods, Ron has identified and implemented procedures to reduce manufacturing variability to acceptable levels.
PUBLICATIONS AND PRESENTATIONS
Managing Product Risk from Cradle to Grave:
In May 2014, Ron presented at the American Society for Quality (ASQ) national meeting (World Conference on Quality and Improvement) a paper titled: Managing Product Risk from Cradle to Grave.
In it, Ron describes how a a five-point risk management strategy was developed for a DuPont business dedicated to the development of medical devices. This strategy took into consideration five different forms of risk: Risk associated with product development, risk associated with the manufacturing process, risk associated with business scenarios, risk associated with stewardship of the product and risk associated with post-market surveillance.
To view the paper, click here: Managing Product Risk from Cradle to Grave (paper)
To view the slide presentation, click here: Managing Product Risk from Cradle to Grave (presentation)
Presented at the March 17, 2016 ASQ Delaware Section dinner meeting
- 21 CFR Parts 11/803/806/807/810/812/814/820
- Auditing (Lead, Process, Product, System)
- Change Initiatives / Change Controls
- Change Management
- Council Directive 93/42/EEC
- Critical-to-Customer / Critical-to-Quality
- Design & Development Planning
- Design Controls
- ISO 9000 / 13485 / 14971
- Manufacturing SOPs / Work Instructions
- Process Development / Process Controls
- Process Improvement
- Process Validations (IQ/OQ/PQ)
- Product Development & Commercialization
- Project Management
- Quality Engineering / QC / QA
- Quality Management / QMS Certification
- Risk Management / Hazard Analysis / FMEA
- Six Sigma
- Supplier Qualification / Supplier QA
Auditing & Audit Process Management
- Obtained Lead Auditor training (FDA Quality System Regulation) – (1990)
- Performed internal company audits in R&D, manufacturing (consumables, instrumentation, service, software) for DuPont Medical Products, Dade Behring, W.L. Gore Medical Products, Hologic, Inc. – (1990 – 2007)
- Managed internal audit programs, including training of auditors, as a part of quality manager responsibilities (1990 – 2014)
- Performed various biotech and medical device supplier and contract manufacturing audits during roles as Global Quality Manager (DuPont Industrial Biosciences) and Quality Systems Director (Actamax Surgical Materials) – (2008 – 2014) (Reference: Makar audit credentials: 2008 – 2017)
- Performed various medical device audits as independent consultant for international medical device companies – (2015 – 2017) (Reference: Makar audit credentials: 2008 – 2017)
- Maintaining three ASQ audit certifications:
- Certified Biomedical Auditor (CBA), Cert. No. 772
- Certified Hazard Analysis and Critical Control Point (HACCP) Auditor (CHA), Cert. No. 787
- Certified Quality Auditor (CQA), Cert. No. 10,459
- Primary interface to 3rd party registrars (BSi, UL, DEKRA)
Continuous Improvement & Training
- Developed and provided hands-on continuous improvement training and guidance in the areas of product development planning, process validation, control and reduction of product and process variability, and product change control.
- Identified and implemented a novel and effective way to present standard operating procedures using information mapping (www.informationmapping.com).
- Managed and directed a multi-disciplined team effort to implement pilot phase of corporate-wide Product Data Management (PDM) system. Through this work, the team was able to demonstrate product development and manufacturing cycle time reduction feasibility and annual manufacturing cost reduction of over $100,000.
- Developed and maintained a customer complaint and CAPA process for a medical products business unit.
- Championed effort to implement EtQ enterprise quality management system (www.etq.com), which was utilized for customer complaint handling and CAPA. This resulted in a more effective management of customer complaints, enabling co-located complaint management units to manage customer complaints in a single system.
General Management & Supervision
- Supervised a production operation of twenty-five assemblers and technicians in the production and quality control of blood chemistry analyzer systems.
- Co-managed the transfer of a production operation from one location to another, with 33% less space, to obtain the same level of production capacity and output.
- Managed product, process and system audits, non-conforming product failure analysis and product reliability testing activities in a medical device production operation.
- Responsible for the release to market of FDA Class II finished medical device products (blood chemistry analyzer systems).
- Established a stage/phase gated product development process in accordance with U.S. CFR Title 21 Part 820, ISO 13485:2013, ISO 14971:2012, MDD standards and regulations and business requirements.
- Designed and developed new product electronic circuitry and electro-mechanical subassemblies for in vitro diagnostic blood chemistry analyzer instrumentation.
- As a member of a product team, in the role of Global Quality Manager, successfully launched an all-natural Omega-3 dietary supplement.
- Managed quality assurance compliance activities for a medical device under development.
- Identified, investigated and resolved production problems for a medical device production operation (blood chemistry analyzer systems).
- Developed and implemented Statistical Process Control (SPC) analysis methods during final (finished) product testing of the production of blood chemistry analyzer systems. This allowed the production organization to more accurately interpret and diagnose test result variation due to special causes vs. normal, inherent process variation, resulting in cycle time reduction and dollar savings in parts replacement.
- Developed and implemented field service modification protocols.
- Provided technical support, including product training, of medical device products to field service engineers and customers.
- Utilizing process capability analysis, developed meaningful and realizable specifications for various products manufactured by contract manufacturing operations.
- Led efforts to validate a Class 10,000 clean room in a medical products development start-up facility.
Quality Management Systems
- Established and maintained several quality management systems to enable the development and commercialization of medical device products compliant to U.S. FDA Quality System Regulation (U.S. CFR Title 21 Part 820), ISO 13485 (2003, 2012), Medical Device Quality System Requirements and ISO 14971 (2000, 2012), Application of Risk Management to Medical Device.
- Implemented an established quality management system in Microsoft® SharePoint.
- Identified and established a mechanism with an external service to manage documents (standards and regulations) of an external origin.
- Managed resolution of customer complaints with diverse business operations groups, including development and implementation of corrective and preventive actions.
- Managed quality management system compliance of a medical device manufacturer’s R&D division to ISO 9001:1994, the FDA Quality System Regulation, and EN46001.
- Developed and implemented a product development and commercialization system compliant with FDA food (21 CFR Part 110) and dietary supplement (21 CFR Part 111) regulations.
- In the role of quality management system Management Representative, developed and presented several quality management system management reviews to company and business management.
- Successfully led business teams to obtain 3rd party certification to ISO 13485:2003, as well as other ISO standards, such as ISO 9001 and ISO 9002.
- Integrated Medical Device Directive (MDD) requirements (Annex II, Annex III and Annex V of the EC-Directive 93/42/EEC of 14 June 1993) into a business quality management system.
- In the role of Quality Assurance & Compliance Manager, assisted Regulatory Affairs Managers in the review and management of regulatory submission data.
- Managed internal auditing programs for several businesses.
- Managed a successful FDA inspection of a medical device manufacturing operation.
- Developed, established and integrated acceptable risk management processes in several quality management systems to ISO 14971 (both 2007 and 2012 versions).
- Facilitated hazard analysis and risk analysis and risk evaluation activities with several medical device development operations.
- In partnerships with critical contract manufacturing operations, ensured that the CMO had performed adequate and effective risk analysis of their manufacturing processes.
- Managed supplier qualification efforts of critical contract manufacturing operations. This involved obtaining assurance that selected critical suppliers were compliant to applicable FDA and ISO quality system regulations and requirements.
- Managed efforts in the development of quality agreements with critical suppliers.
- Interfaced directly with critical contract manufacturing operations on a regular basis, to review, approve and release production lots.
- Innovative Quality Consulting, LLC, Owner, Principal Consultant (Wilmington, DE); 2015 – present
- Actamax Surgical Products LLC, Director, Quality Management (Wilmington, DE); 2011 – 2015
- I. DuPont de Nemours & Co., Inc., Global Quality Manager (Wilmington, DE); 2007 – 2015
- Hologic, Inc., Plant Quality Assurance Manager (Newark, DE); 2002 – 2007
- L. Gore & Associates, Inc., Quality Assurance Associate (Elkton, MD)
- Dade Behring Inc., Quality Assurance & Compliance Manager (Newark, DE)
- E. I. DuPont de Nemours & Co., Inc. (Newark, DE)
- QA & Compliance Manager
- Product Development, Process and Quality Management Engineer
- Production & Product QA Supervisor
- Field Service Technical Support Engineer
- Master in Engineering (Biomedical Engineering), University of Virginia, Charlottesville, VA
- Bachelor of Science (Medical Technology), University of Bridgeport, Bridgeport, CT
- Associate in Science (Electrical Engineering Technology), Norwalk State Technical College, Norwalk, CT
Ron maintains five active certifications with the American Society for Quality (ASQ). Feel free to click on the links, below, to view the scope (body of knowledge) of each certification.
- Certified HACCP (Hazard Analysis and Critical Control Points) Auditor (CHA) – (Cert. No. 787) – 3/10 to Present
- Certified Manager of Quality/Organizational Excellence (CMQ/OE) – (Cert. No. 3187) – 3/98 to Present
Ron’s professional training includes the following:
- ISO 13485:2016 Lead Auditor Training, www,caliso.com (July 2017)
- ISO 13485:2016 Changes and Implementation Best Practices, ASQ Biomedical Division (May 2016)
- Six Sigma Green Belt Training, E.I. DuPont de Nemours & Co., Inc. – (10/08)
- Six Sigma Greenbelt Overview Series, American Society for Quality – (4/07)
- ISO 14971:2007 [Risk Mgt. for Medical Devices], Assoc. for the Advancement of Medical Instrumentation (AAMI) – (4/07)
- Understanding and Implementing the New ISO 13485:2003 Standard, EXCEL Partnership Inc., – (1/06)
- R&D Risk Management & FMEA, LOGICON – (11/00)
- Understanding Financial Business Management, SMG – (4/99)
- 21 CFR Part 11 – Electronic Records and Signatures, FDA – (1/99)
- Planning and Managing Projects, Integrated Project Systems – (3/98, 5/98)
- Understanding the New Medical Device GMP, Stat-A-Matrix – (10/96)
- Advanced Auditing Techniques: Process Auditing, Stat-A-Matrix – (1/96)
- Quality Engineering Course, CQE, Total Business Service Center, Inc. – (11/95)
- Quality Auditing Course, CQA, Total Business Service Center, Inc. – (6/94)
- Statistical Process Improvement Techniques for Process Validation, Logicon R&D – (6/94)
- Management Problems of the Technical Person in a Leadership Role, Fred Pryor Seminars – (3/94)
- Collaborative Problem Solving, DuPont Corporate Continuous Improvement Curriculum – (8/93)
- Train the Trainer, Fred Pryor Seminars – (9/92)
- On-The-Job Auditor Training, Batalas – (8/92)
- Product Quality Management System Technology, DuPont Quality Management & Training Center – (6/92)
- Lead Assessor Certification, Batalas – (8/92)
- Deming Philosophy, DuPont Medical Products – (12/89)
- Medical Device GMP’s and Regulations – Quality Program Preparation and Audit, Stat-A-Matrix – (11/89)
American Society for Quality (ASQ), Senior Member (Member No. 00947837) – 1989 to Present