The Quarem Team

Success is built together, through shared vision, trust, and genuine collaboration. As an extension of your team, we bring deep MedTech quality and regulatory expertise with a people-first approach, working side by side with you to deliver right-sized solutions that are practical, effective, and meaningful.

Xiaoyi Wang

Principal

As a proven leader with over 20 years of experience spanning Quality, Regulatory Affairs, and Operations, Xiaoyi brings deep expertise in navigating complex regulatory landscapes and driving operational excellence across the entire product lifecycle. For more than a decade, she has specialized in the healthcare quality and regulatory environment, ensuring compliance and strategic alignment from early development through post-market activities. A trusted partner, she is known for bridging technical rigor with strategic execution—delivering solutions that enable both innovation and sustainable growth

Tiea Theurer

Consultant

Tiea is a seasoned Quality and Regulatory professional with over 20 years of experience driving compliance and operational excellence across the medical device and diagnostics industries. She brings deep expertise in FDA remediation, design controls, risk management, and CLIA regulations, helping teams strengthen systems and achieve regulatory readiness. Tiea has a proven track record auditing for Notified Bodies in the medical device and in vitro diagnostic sectors, demonstrating expertise in IVDR, MDR, ISO standards, and MDSAP frameworks.

Glen Wagner

Consultant

Glen is an accomplished engineering leader with over 30 years of experience in quality management, software validation, and innovative technology development. His career spans Fortune 500 companies and entrepreneurial ventures, with a consistent focus on delivering high-quality, user-centered solutions. At Intel, Glen advanced through engineering and quality leadership positions over more than two decades, helping to shape the company’s approach to product reliability and digital health. He later served as Quality Director for Care Innovations, an Intel–GE Healthcare joint venture, overseeing validation testing and quality systems for remote health and assistive technologies.