Jingyi L.

About Jingyi L.

As a Lead Auditor at TÜV SÜD, I specialize in regulatory compliance, audit management, and technical documentation assessment for medical devices and in vitro diagnostics. With expertise in ISO 13485, ISO 9001, MDSAP, IVDR, and MDR, I lead audits and assessments that help organizations meet global standards and deliver timely, compliant outcomes.Previously, as a Senior Scientist at MicroGEM, I developed a strong foundation in analytical problem-solving and operational efficiency. I now apply that experience to strengthen quality management systems, mitigate risks, and foster cross-functional collaboration. My mission is to uphold regulatory excellence while driving continuous improvement across the product lifecycle.

Experience

1. Lead Auditor and Product Reviewer

   TÜV SÜD

   Jan 2023 — Present · VA, US

   Conducted audits of medical devices, instruments, software, reagents, and consumables to ensure compliance with ISO 13485, ISO 9001, MDSAP, IVDR, and MDR. Reviewed technical documentation against IVDR standards. Designed and executed audit programs. Deliver timely, accurate, and compliant results.

Education

• University of Minnesota

  Master of Science (M.S.), Materials Chemistry

  2006 — 2008

• University of Virginia

  Doctor of Philosophy (Ph.D.), Analytical Chemistry

  2008 — 2012

• Tianjin University

  Bachelor’s Degree, Chemistry

  2002 — 2006

Skills

• Laboratory Skills
• Pcr
• Dna Extraction
• Organic Chemistry
• Laboratory
• Nmr
• Mass Spectrometry
• Science
• Surface Chemistry
• Fluorescence Microscopy
• Research
• Analytical Chemistry
• Chemistry
• Uv/Vis Spectroscopy
• Xps
• Genetics
• Electrophoresis
• Biotechnology
• Image Analysis
• Mathematica
• Materials Science
• Fluorescence
• Polymerase Chain Reaction (Pcr)
• Statistical Data Analysis
• Uv/Vis
• Microfluidics
• Assay Development
• Nanotechnology
• Purification