Hands-On Experience That Moves Devices Forward
Decades of leading quality, regulatory, and risk programs for diagnostics, cooling therapies, and vascular devices across the US and EU ensure your submissions stay on track.
Principal Quality & Compliance Consultant
Dang C&C Services · 2018 – Present
Guides CryoLyse, Euphrates Vascular, IdealMed, and SpinaFX through global commercialization by embedding compliant QMS infrastructure and leading regulatory remediation.
- Aligns combination product portfolios with ISO 13485:2016, FDA QSR, and EU MDR expectations.
- Provides interim QA/RA leadership to integrate risk management, document control, and training systems.
Quality & Compliance Director
BeneChill, Inc. · 2012 – 2016
Directed enterprise-wide QMS and regulatory strategy for a class II cooling device manufacturer across EU and US markets.
- Delivered CE technical files, FDA submissions, and global registrations supporting product launches.
- Led cross-functional design control and clinical teams to maintain audit-ready documentation.
Sr. Staff Quality Systems Engineer
Illumina · 2016 – 2018
Optimized design transfer and supplier quality programs for high-throughput diagnostics, maintaining FDA and ISO compliance.
- Championed CAPA and risk-based process improvements improving readiness for regulatory inspections.
- Instituted quality metrics and training that strengthened manufacturing release decisions.
Sr. Quality Assurance Specialist
Sequenom, Inc. · 2007 – 2009
Built foundational quality procedures, training, and change control for molecular diagnostics heading toward FDA and ISO 13485 approvals.
- Established company-wide training systems and document hierarchies to support compliant scale.
- Partnered with R&D and manufacturing teams on validation, supplier quality, and material review boards.
Selected Leadership Engagements
Each engagement blends regulatory strategy with operational execution to drive approval and readiness outcomes.
Quality & Compliance Director
BeneChill, Inc.Jan 2012 – Feb 2016- Managed enterprise QMS supporting Operations, R&D, Regulatory, and Clinical programs in a scaling startup.
- Maintained ISO 13485, 21 CFR Part 820, and EU MDD compliance across manufacturing operations.
- Supported CE technical files, FDA submissions, and international device registrations.
- Led design control initiatives and investigator-sponsored clinical trials readiness.
Sr. Staff Quality Systems Engineer
IlluminaJan 2018 – Jul 2018- Led product quality investigations and corrective actions across development teams.
- Established metrics and dashboards to improve quality system processes.
- Ensured compliance with 21 CFR Part 820 and ISO 13485 through cross-functional training.
- Partnered with R&D to enhance design transfer and supplier qualification.