Cynthia possesses 25+ years of industry experience with proven leadership in Class I, Class II, and Class III medical device quality assurance. Since joining Veranex in 2021, Cynthia has applied her widespread background in both U.S. and international markets to successfully provide results to our clients and team. Cynthia is a strong collaborator with an intentional and diligent work ethic. Cynthia possesses considerable product experience with non-significant risk technologies, capital equipment, microwave-based dermatologic systems, RF-based, EP and orthopedic systems, laser-based transmyocardial systems, cardiothoracic stents, bone cement and delivery systems, pulmonary tools, and enteral feeding tubes.
At Veranex, Cynthia is responsible for quality management system (QMS) assessment, implementation, and auditing of companies with diverse product lines. She supports corrective and preventive actions (CAPAs), complaint handling, medical device reporting to regulatory authorities, and regularly performs gap analyses, internal audits, and other quality assessments. Her additional functions include:
- Phased design control projects for U.S. FDA Class I, Class II, and Class III traditional medical devices, combination products, capital equipment, mobile health technologies, and software driven medical devices
- Project management activities for clients with multiple ongoing projects, including tracking of project deliverables, budget management, and coordination of resources across project teams
- Quality management system activities, including document control, design control, product labeling and specification development, CAPA-related activities, and risk management activities
- Interfacing with FDA inspectors, notified body auditors, and state of California Food and Drug Branch (FDB) inspectors
- Reviewing medical device labeling and marketing materials, including websites, to ensure regulatory compliance
Past companies and experience
Cynthia has successfully directed and mentored several teams in the establishment of scalable quality management systems, design control efforts, MDSAP certifications, and complaint handling to ensure success of product development.
Cynthia most recently served as the vice president of Serpex, Inc. where she upheld the responsibility of directing engineering staff on design control deliverables while developing and maintaining a QMS compliant to the FDA’s Quality System Regulation 21 CFR Part 820 and ISO 13485. Her prior experiences include roles of increasing responsibility at miraDry Inc. where she quickly ascended from senior manager of quality assurance to an acting manager of Regulatory Affairs and senior Director of Quality Assurance. Cynthia’s accomplishments include the achievement of certification to MDSAP, hosting numerous U.S. FDA, California state FDB and notified body audits, and overall leadership and development of efforts related to compliance, product complaints/safety, design control, risk management activities, and regulatory submission efforts. Cynthia also held management roles at ArthroCare Corporation, Kyphon, and Boston Scientific.
Cynthia received her B.S. in industrial technology and M.S. in quality assurance from San Jose State University, California.