Stuart Goldman - Senior Consultant, Quality Assurance & Regulatory

If anyone understands the demands placed upon medical device companies, it's Stuart. Before joining Emergo, Stuart spent 15 years with a manufacturer of high-risk cardiovascular implants and was responsible for all facets of the company's compliance with FDA GMP and ISO 13485. He has extensive experience with auditing and quality control of subcontractors.

Stuart has an in-depth knowledge of the US FDA regulations, the European Medical Device Directive and ISO 13485 standards. His training as a Materials Engineer gives him a strong understanding of the risks associated with the use of advanced materials in devices. At Emergo, Stuart focuses primarily on helping clients with regulatory compliance including device classification, CE Marking Technical Files, FDA 510(k) submissions and risk analysis.

EXPERIENCE:

Quality Assurance Engineer & Supervisor, CarboMedics Inc. - A Sorin Group Company (1991-2006)

• Managed the company's internal audit program to ensure compliance of its Quality Management System to the national (U.S.) and international (EU) regulations.
• Established and executed the yearly internal audit schedule. Supervised, trained, mentored and guided small group of internal auditors.
• Point contact during FDA and Notified Body audits.
  
• Supported and ensured compliance of the company's formal CAPA system.
• Performed device tracking audits of product in the field to ensure proper distribution, handling, storage, and traceability of critical cardiovascular products for compliance with the FDA CFR (Parts 820/821).
  
• Conducted and lead internal quality and regulatory compliance audits of all functional departments and groups within the company, and divisional companies in the Sorin Group in North America and Europe.
• Reviewed audit findings with department management/personnel, assigned appropriate corrective/preventive action(s), and performed follow-up audits to ensure proper effectiveness of corrective/preventive action(s).
• Supported the company's departmental quality goals, including cost reduction and process improvement activities.
  
• Developed solutions to complex quality problems using modern quality tools to measure and tracked key performance indicators.
  
• Conducted annual corporate-wide training on various topics related to the FDA CFR Parts 820/821 and ISO 9001/13485.
• Developed and implemented the company's Supplier Quality, Internal Audit, Record Retention and Customer Focus policies.
• Developed strategic alliance with natural/organic bovine abattoirs for sourcing low-risk BSE tissue for use in the company's proprietary line of medical devices.
• Managed CarboMedics' Approved Supplier Program to ensure compliance of its global supplier base to its quality policies and the national and international regulatory requirements.
  
• Developed and implemented systems to reduce the number of suppliers while maintaining product quality and reducing costs.
  
• Coordinated the company's supplier quality assurance efforts and provided quality and technical liaison with its suppliers.
  
• Lead and facilitated team efforts to establish and monitor customer/supplier relations.
  
• Interfaced with the Purchasing, Manufacturing and Quality Control Departments on supplier related activities.
• Performed new (and annual) supplier screening, evaluation, selection, auditing and monitoring activities.
• Established and implemented risk-based criteria for identifying and selecting critical suppliers to ensure best fit, customer/supplier partnerships that balanced short-term gains with the long-term goals of the company.
• Reduced the number of molding suppliers by 80% resulting in a 32% reduction in the number of DMRs related to molded instruments over a three year period.
• Educated and trained suppliers on the company's quality standards.
• Issued corrective action(s) requests to suppliers in response to audit findings and ensured effective closure of those findings with suppliers.
• Maintained company's approved supplier database.

AREAS OF EXPERTISE:

Medical Devices:

• Dental
• Orthopedics
• Cardiovascular
• Implants
• Mobility aids
• Opthamalic/optical
• Patient monitoring
• Prostheses
• Reusable instruments
• Surgical instruments
• Medical polymers
• High risk devices

QA & RA:

• ISO 13485:2003
• ISO 9001:2000
• EU MDD 93/42/EEC
• CE marking & product labeling
• EU Technical File & Design Dossier Compilation
• Medical Device Classification
• FDA 510(k) & 513(g) submissions
• FDA Quality System Regulation (21 CFR Parts 801, 803, 820)
• Supplier audits
• ISO 13485:2003 & 21 CFR Part 820 audits
• Risk Management audits

CERTIFICATIONS:

• American Society for Quality - Certified Quality Manager (CQM)
• American Society for Quality - Certified Quality Auditor (CQA)
• American Society for Quality - Certified Biomedical Auditor (CBA)
  
• RABQSA International - Quality Management System Auditor (QMS-A)

EDUCATION:

• Bachelor of Science, Materials Engineering, North Carolina State University.

HOME BASE:

• Texas, USA