• 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

• 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

• 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

• 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