Has 35 years of medical device industry experience with several major medical device companies in several roles including Chief Quality Officer, and Director of Operations & Quality. She uses proprietary tools and participative methods based on Systems and Total Quality Management theoretical foundations to streamline and implement quality processes and has performed the following:
- Led efforts to ISO registration success in both ISO 9001 and ISO 13485:2003 for medical device manufacturers and high tech organizations.
- Designed and implemented training programs for medical applications resulting in audit compliance success.
- Founded software and consulting company specializing in online collaborative process design and optimization tools, ISO 9001:2000 and ISO 13485:2003 compliance tools and services.
- Led cross-functional team tasked with increasing customer satisfaction to achieve customer goals, increasing successful customer systems implementations 93%.
- Created inventory control self-managed work teams whose accomplishments included increasing inventory accuracy of >25% (70% -95 %+) in multiple stocking locations.
- Managed cross-functional team to develop and implement financial level security solutions for Internet infrastructure company. Implemented patentable system exceeding customer requirements.
- Directed program management team for new product introduction in medical electronics, achieving on time new product delivery.
- Managed medical data analysis service bureau for 60+ customers including marketing, sales, customer support and training.
- Implemented Quality Management programs in multiple environments from Food & Drug Administration (FDA) regulated Good Manufacturing Practices through meeting ISO 9000 and ISO 13485 requirements.
- Founding member and participant on Manufacturing Quality Post Mortem Team that changed final quality defect rate from 30 + % to less than 2%
OUR ELECTRICAL ENGINEER
Has 37 years of international and domestic industry experience as a Manufacturing Engineer, Senior Quality Engineer, Production Planner, and has been in charge of several major start-ups for industry. He has also been the Sr. Director of Quality and Regulatory Affairs at a major medical device company.
He is an expert at all types of risk analyses to help support a risk-based quality system. He has been providing consulting to medical device companies since 2010 performing audits and gap analyses and helping to manage and complete 100 DFMEAs and PFMEAs for a company with a large number of different product lines.
He has held the following positions:
- Sr. Director of Instrument Manufacturing, Quality and Regulatory Affairs, Supply Chain and Sustaining Engineering Operations – responsible for transforming the instrument manufacturing area into a FDA-compliant area.
- Sr. Director of Manufacturing – responsible for all aspects of instrument manufacturing. Managed purchasing, production planning, instrument manufacturing and manufacturing engineering in a FDA regulated environment.
- Architect Production Manager – responsible for managing the Architect Instrument Analyzer production Start-up. Managed 100 employees, $4MM of instrument through put per month. Managed three department budgets over $5MM per year.
Provides services to medical device and diagnostics, pharmaceutical, and ophthalmic companies in project management, completing development, quality and regulatory compliance including full documentation packages as required by FDA and EPA, and managing clinical studies. He has developed and submitted approximately 40 510(k) Premarket Notifications for approximately 40 medical devices, instrument systems, and diagnostic products.
Some of the positions he has held include:
- Chief Technical Officer and Executive Vice President of Technology & Manufacturing Operations – responsible for transitioning products from the development mode to full scale manufacturing, this includes contracting and working with contract manufacturers to assure that the products will be made in full compliance with FDA and EPA regulations.
- Senior Vice President – responsible for managing Operations, Laboratory Services, Business Development, Quality Assurance, Clinicals, and Regulatory Affairs.
- Vice President Operations, Clinicals & Regulatory Affairs - responsible for developing and implementing an organization fully capable in chemistry production, instrument production, manufacturing services, materials management, quality assurance and regulatory affairs. This includes assuring the orderly transition of products from R&D and engineering to operations. Also, included design and implementation of the clinical study protocol for the Abaxis product and to assure compliance with required government regulations. This also includes Document Control System and coordination of Good Manufacturing Practices within the company and preparing and obtaining approximately twenty 510(k) premarket notifications.
- Advanced Biosearch Associates – Consultant – responsible for development of clinical trial designs and implemented Good Manufacturing Practices for client companies (medical device, medical, diagnostics, and ophthalmic) for successful Investigational Device Exemptions (IDE) and Premarket Approval Applications (PMA) and Premarket Notifications 510(k) to the Food and Drug Administration.
- Vice President, Operations – responsible for setting up a manufacturing organization, a quality assurance function, materials management, regulatory affairs and clinical studies. Designed and had custom built an automated manufacturing process for the cost-effective manufacture of a dry film strip. Established a manufacturing relationship with two contract houses for high volume assembly of a sophisticated blood glucose monitor. Provided regulatory compliance with all government agencies including product submissions, Device Master Records, and policies and procedures that are in accordance with cGMPs.