Kristin Shang
Design Quality Manager @Teladoc Health
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WORK HISTORY
Design Quality Manager @Teladoc Health
Process owner of Design Control and Risk Management for New Product Development in our virtual care telehealth platforms. Strategize and oversee successful product launches in Software (SaMD) for Mobile App and Cloud, Hardware medical and non-medical devices.Ensure Design Control process is followed, and all Design Control deliverables with rise-based approach are accounted for. Ensure compliance with FDA QMSR, ISO 13485, ISO 14971, MDSAP, IEC 62304 SDLC, and FDA Cybersecurity guidance. Under my supervision, products launched/ updated include but not limited to: Digital health telemedicine Mobile App and Cloud with agentic AI Chatbot for Chronic Care Management, i.e. programs like weight & diabetes (with GLP-1 prescription), hypertension, heart failure, chronic kidney disease (CKD), mental health offered to Teladoc Health members. With the use of at-home test kits, Class II connected medical devices (including implantables), and wearables would allow data sync to Mobile App and Cloud. Mobile App software functions that offer personalized Cardiometabolic health insights and nutrition management with AI and Optical Character Recognition (OCR) features. Virtual telehealth Hospital & Health Systems, featuring AI/ML-enabled doctor-patient consultation and monitoring.
EDUCATION
The University of Hong Kong
SSI
UC San Diego
BS, Chemical Engineering
ABOUT KRISTIN SHANG
My thoughts I carry to work: I ensure the products we launch are safe and effective enough to be used on my own family. Over 15 years of medical device experience as a Quality Engineering leader in both highly regulated and startup environments. Proficient in Design Control process throughout product lifecycle. Proven track record in Supplier Quality Management with USD$680M worth in supplier contracts. Relationship liaison to build and maintain long-term trust and engagement with global suppliers to ensure product quality and lean supply chain efficiency. Dedicated to mentorship to improve Quality Management System in the organization.Certifications:Mini-MBA in Healthcare, University of Arizona Mar 2024BSI MDSAP Fundamentals and Readiness (BSI cert # 36••••••••88) Aug 2022AAMI Design Control Requirements against ISO 13485:2016 Nov 2020Certified Six Sigma Green Belt (ASQ certificate # 16942) Mar 2017Project Management Professional(i) Dec 2016Certified ISO 13485 Lead Auditor (DEKRA AQS certificate # Q18152) Dec 2013Certified CAPA Initiator/Evaluator, Investigator, Resolution Planner (Abbott Vascular) Sept 2012\"
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