Merry Xiao
Quality Assurance & Regulatory Affairs Associate Manager @iHealth Labs
Signup · Get unlimited contacts
WORK HISTORY
Quality Assurance & Regulatory Affairs Associate Manager @iHealth Labs
San Francisco, CA, US
Built and implemented an eQMS aligned with 21 CFR 820 (QSR) and ISO 13485; currently managing continuous improvement initiatives to ensure compliance with FDA QMSR, MDSAP, and evolving customer requirements.* Serve as SME for document control, change management, and training administration in a shared-eQMS environment.* Host FDA inspections and audits. Played a key role in passing a week-long unannounced FDA inspection with zero observations and achieving ISO 13485 certification.* Prepare QMS performance reports, coordinate Management Review Meetings, and manage improvement projects.* Partner with Engineering and Product for the development of IEC 62304-aligned SaMD products, including creation of SOPs and work instructions, design controls, risk assessments (ISO 14971), verification, validation, DHF/DMR, and 510(k) submissions.* In charge of supplier qualification, monitoring, and requalification of QA suppliers.* Support complaint handling, MDRs, nonconformity investigations, root cause analysis, CAPAs, and CRB activities.
EDUCATION
Xiangtan University
Bachelor of Engineering, Environmental Engineering
South China University of Technology
Master of Science, Food Science and Technology (with a focus on plant proteins and functional foods)
University of Toronto
Master of Engineering , Industrial Engineering (majored in QA, Supply Chain Management, Computer Integrated Manufacturing)
SKILLS
ABOUT MERRY XIAO
Quality and compliance leader with extensive experience in FDA-regulated manufacturing environments, including medical devices, IVDs, SaMD, and consumer health products across North America and Asia. I bring a balanced background in practical quality assurance and regulatory compliance leadership, as well as hands-on quality assurance/engineering, enabling me to contribute effectively both in management roles and as a senior individual contributor within growing organizations.At iHealth Labs, I have built and implemented an eQMS. My main scope includes the maintenance and improvement of the eQMS, management review, improvement initiatives, document control, change control, training administration, supplier quality management, and audits, serving as the SME for document control, change control, and training within a shared QMS environment.I lead QMS strategies, cross-functional alignments, and inspection readiness, including successfully passing a week-long unannounced FDA inspection with zero observations. During the inspection, I professionally engaged with an FDA investigator to clarify regulatory interpretations as needed, helping to resolve potential issues in real-time and ensuring the accurate application of regulations. I\'m a key member in having achieved ISO 13485 certification and preparing for MDSAP certification.I also support SaMD products across the full product lifecycle from planning, creation of SOPs/WIs, design control, risk management (ISO 14971), verification, validation, DHF/DMR review to 510(k) submissions, as well as product post-market, including complaint handling, MDRs, nonconformity investigation, root cause analysis, CAPA, and CRB activities.Earlier in my career, I held Quality, R&D, and Production plant-level management roles in FDA-regulated food manufacturing, where I led multiple QMS build-and-recovery initiatives. I helped companies build QMSs from the ground up and achieve global certifications with top ratings, enabling business cooperations with large customers, such as Costco. I also supported organizations that had failed customer-mandated certification audits and were at risk of losing key customers, leading comprehensive quality system upgrades and implementation efforts that resulted in successful recertification, expanded product portfolios, and significant business growth.These experiences strengthened my ability to design, implement, and scale pragmatic Quality Management Systems that ensure high-quality products, restore compliance, support business continuity, and enable growth.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.