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Work Background
Quality System Modelers, LLCChief Executive Officer
May. 2023Fresno County, California, United StatesQuality System Modelers, LLC provides Quality Management System expertise and guidance for medical device manufacturers. - Lead expert for all consulting services including QMS creation, management, improvement, remediation, monitoring, and tool creation compliant with worldwide regulations and standards.
Sunrise MedicalSr. Director QA/RA
Nov. 2017 - Apr. 2024Fresno, California AreaSunrise Medical develops, designs, manufactures and distributes manual and powered wheelchairs, mobility scooters and both standard and customized seating and positioning systems. - Served in capacity of North American Management Representative and Person Responsible for Regulatory Compliance (PRRC). - Provided oversight on QMS processes including deviations, investigations, CAPAs, complaints, risk management, and design controls. - Implemented North American processes for hosting regulatory inspections and served as primary liaison. - Implemented processes to ensure compliance with all applicable FDA, EU, and Rest of World regulations, standards, and guidance documents.
Neozene, Inc.Senior Director, Technical Engagements & Quality
May. 2015 - Aug. 2017Oakland, California, United StatesNeozene is a high-performance CRO and professional services organization focused on providing solutions for life science manufacturers. - Established new and remediated existing Quality Management Systems for clients - Created and implemented formal training programs for organizations on Quality and Regulatory Requirements including QSRs, CAPAs, Risk Management, Design Controls, inspection techniques, audit readiness, etc. - Led quality audits assessing compliance with 21 CFR 820, ISO 13485, MDD 93/42/EEC, CMDR SOR/98-282, MDR EU/2017/745, IVDR EU/2017/746, MHLW MO No. 169 (Japan), TGA (Australia), etc. - Provided direct oversight of all inhouse Quality and Regulatory subject matter experts as well as project leadership and oversite for client projects. Managed budgets and resource allocations.
Self-employedQuality System Consultant
May. 2008 - May. 2015San Jose, California, United StatesServed clients in the capacity of a QMS leader or Subject Matter Expert. - Created new or enhanced complaint investigation, CAPA (including root cause analysis), NCMR, compliance readiness, and process enhancement programs. Led associated implementation activities and provided professional training and certification. - Provided Quality expertise for new product development projects for all classifications of devices. - Lead Auditor for quality audits assessing compliance with 21 CFR 820, ISO 13485, MDD 93/42/EEC, CMDR SOR/98-282, MDR EU/2017/745, IVDR EU/2017/746, MHLW MO No. 169 (Japan), TGA (Australia), etc.
Genentech, IncTechnical Manager
Jul. 2002 - Sep. 2007South San Francisco, CAInnovative biotechnology corporation widely considered to have founded the biotechnology industry. - Led an enterprise-level process improvement project team that resulted in an 80% reduction in manufacturing rejects and saved ~$150,000 annually. - Led a production process improvement project team that resulted a 56% improvement in turn-around-time while maintaining resource levels. - Developed and performed professional in-house training courses for risk management, root cause analysis, compliance practices and regulations, etc.
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