# Danli Wang > Strategic MedTech Quality Leader | Transforming Design Assurance, Supplier Quality & Global Compliance Location: Pleasanton, California, United States Profile: https://flows.cv/danliwang Global MedTech Quality Executive with 20+ years of experience leading enterprise-wide quality strategies for Class I–III medical devices and IVDs products. Proven ability to build high-performing teams and drive design assurance, supplier quality, and regulatory compliance across U.S., EU, and APAC markets. Recognized for transforming quality systems from reactive to proactive, enabling innovation, and accelerating time-to-market through operational excellence and process optimization. Passionate about fostering collaboration, building trust, and delivering measurable business results while ensuring compliance with FDA, ISO 13485, EU MDR/IVDR, and global regulations. Certified Lean Six Sigma Green Belt. ## Work Experience ### Supplier Quality Director @ Abbott Jan 2025 – Present | Pleasanton, California, United States • Lead global supplier quality strategy to support compliance, risk mitigation, and business growth • Oversee supplier audits, incident resolution, and third-party manufacturing across domestic and international sites • Align quality systems with global regulatory requirements to support timely approvals • Collaborate cross-functionally to drive proactive supplier readiness and operational efficiency • Drive supplier excellence and compliance activities to improve supplier control process maturity ### Site Quality Head @ Abbott Jan 2023 – Jan 2025 | Santa Clara, California, United States • Served as Management Representative and Person Responsible for Regulatory Compliance (PRRC), ensuring the site’s QMS met regulatory requirements and aligned with Abbott Quality & Regulatory (AQR) policies • Directed site QA activities and budget, setting strategic quality direction and engaging with executive leadership, regulatory agencies, customers, and suppliers • Led governance and oversight mechanisms including quarterly management reviews, monthly quality metrics, and formal quality improvement plans to inform division-level decisions ### Director of Design Quality and Supplier Quality @ Abbott Jan 2021 – Jan 2023 | Santa Clara, California, United States • Developed mid to long term Design/Pre-market Quality and Supplier Quality strategies, annual operation budget and resource plan to support NPD activities, Third-Party Manufacturing (TPM) activities, and sustaining product reliability, and growth margin improvements for the Hema business unit product portfolio including instruments, medical device software products, and medical reagents. • Partnered with other Abbott divisions to develop new metrics/KPIs to measure & improve design control process and drove supplier component qualification and the Right First-Time Quality improvement initiatives ### Director Of Quality Assurance @ Siemens Healthineers Jan 2017 – Jan 2021 | Greater Boston Area • Served as the Quality & Regulatory (Q&R) management representative to Siemens Healthineers Diagnostics Manufacturer (SHDM) leadership team and developed & implemented Q&R strategies for a major global initiative ($300M+ investment) to build a brand new IVD manufacturing site in China • Interacted with global regulatory agencies (NMPA, GACC, FDA, & USDA) and optimized product registration strategies; successfully reduced registration time and cost by ~35% and ~25%, respectively • Drove Q&R operational excellence and continuous improvement initiatives; developed a lean QMS for SHDM that complies with Siemens Corporate policies, International Standards (ISOs), and NMPA (former CFDA) regulations; led the development of global multi-site quality interface agreements and comprehensive training programs • Developed the SHDM Q&R organizational vision & roadmap; built a patient-centric preventive quality culture by working with cross-functional senior management teams, monitoring SHDM quality performance metrics (KPIs), and leading site management reviews • Established a high-performance, diversified Q&R team (QA, QE, QC & RA) by fostering a development-focused environment, promoting open communication & collaboration, and improving the recognition program ### Head Of Quality @ Medtronic Jan 2016 – Jan 2017 | Greater Memphis Area ### Sr. Design Quality Engineering Manager @ Medtronic Jan 2014 – Jan 2016 | Greater Memphis Area ### Sr. Quality Engineering Manager @ Medtronic Jan 2012 – Jan 2014 | Global assignment in China ### Manager, Design Quality Engineering @ Medtronic Jan 2009 – Jan 2012 | Greater Memphis Area ### Sr. Quality Assurance Engineer @ Medtronic Jan 2006 – Jan 2008 | Greater Minneapolis-St. Paul Area ### Quality Assurance Engineer @ Medtronic Jan 2005 – Jan 2006 | San Francisco Bay Area ### Sr. Medical Sales Representative @ AstraZeneca Jan 1995 – Jan 1998 | China ## Education ### M.S in Biomedical Engineering Georgia Institute of Technology ### M.S in Computer Engineering University of Central Florida ### B.S in Applied Chemistry Sun Yat-sen University ## Contact & Social - LinkedIn: https://linkedin.com/in/danli-wang-2028414 --- Source: https://flows.cv/danliwang JSON Resume: https://flows.cv/danliwang/resume.json Last updated: 2026-04-13