With over 20 years of leadership in the MedTech and life sciences sectors, Joelle specializes in
building and optimizing quality management systems (QMS) for regulatory compliance and
operational excellence. Her expertise spans FDA QSR, EU MDR/IVDR, ISO 13485, ISO 14971, and
ISO 9001, with a proven track record in audit readiness, post-market surveillance, CAPA
processes, and risk management for Class III devices, diagnostics, and wearables.

As a fractional consultant, Joelle helps MedTech OEMs and CMOs navigate complex regulatory
landscapes, implement lean QMS in ERP systems, and drive compliance strategies that
accelerate market entry and growth. Key achievements include:

• Leading QMS implementation and ISO 9001 certification for global MedTech operations,
  reducing waste by up to 83% through automated testing and inspection.
• Overseeing FDA-compliant product launches and validations for startups and
  established firms, including cardiovascular devices, blood glucose monitors, and hospital
  single-use systems.
• Revamping CAPA programs to eliminate recurring complaints, boosting Net Promoter
  Scores to 100, and managing teams to achieve 400% revenue growth in portfolio
  companies.

Joelle holds an MBA from UCLA Anderson, a BS in Chemical Engineering from UC Berkeley, and
certifications in Lean Six Sigma, PMI Program Management, and Advanced Risk Management.
She excels in providing crisp, customer-centric tools for lean, compliant operations—ideal for
short-term engagements focused on regulatory strategy, inspection preparedness, and quality
system overhauls.