United States
• Led post-market surveillance and adverse event reporting. • Chaired monthly Quality Management Reviews and managed technical files. • Developed quality/regulatory trend reports and conducted regulatory training. • Performed quality and regulatory data mining, trend analysis.
• Improved product quality through data analysis and trend reporting standards. • Managed global product recalls and ensured regulatory compliance. • Supported cross-functional teams in legal, marketing, and engineering projects. • Developed and implemented quality trend/analysis/control metrics, reporting formats (adopted by HQ as organizational standard in data analysis/quality reporting) improving product quality, data accuracy, data effectiveness, including data communications.
• Led follow-up oversight activities across various product lines to guarantee quality. • Summarize and coordinate quality concerns with engineering and management. • Ensure cleanroom compliance and audit final product inspections. • Performed Daily DHR reviews, final product release for distribution.
• Participated in Team-Coordinated Good Manufacturing Practice (GMP) Audits. • Performed final product and in-process inspections utilizing a Quality Management System (QMS). • Presented and briefed manufacturing teams on revised/new procedures and blueprints. • Collaborated as a team member in FDA Audits.
• Managed databases for all inspection activities, document control, software archives, and ECNs. • Worked closely with engineering to determine product inspection criteria. • Supported and collaborated with engineering, production, sales, and logistics. • Performed various phases of inspections; final product, in-process, and in-coming.