Carl Wu Email & Phone Number

Austin, Tx

Taiwan

Quality Management System implementation and application, including:-Drive management of change activities often as a result of CAPA, customer request, or continuous improvement objectives-Regular meetings with customers, including VPT, audits, SCAR follow up, business review, etc-Drive non-conforming material investigations including supplier investigation, statistical trending review, root cause analysis, etc-Using SAP ERP system to perform batch record reviews, quality data trending, produce CoC/CoA, monitor production resources, etc-Act as quality subject matter expert for new project development, ensuring compliance with FDA CFR 820, ISO 13485, ISO 11608, and EU Medical Device Regulations-Quality agreement modification-QMS update and improvement-Ensure Validation and Verification activities follow QMS standard-Supplier Qualification activities

Plano, Texas, United States

Manage SQF, Regulatory, Quality Control, and Data Analysis departments to promote collaboration and proper communication both internally and between departmentsApply SQF, ISO, and Quality Management principles to drive process improvementCreate statistical database utilizing Lean Six Sigma principles to analyze key process indicators and present quality data to managementLead all company inspections and audits - internal, customer, regulatory, and certificationManage all customer complaints and nonconformities in coordination with sales, marketing, R&D, and manufacturing departments, including root cause analysis, investigation, and action timetablesIdentify trends in quality data to improve on any gaps in the quality management systemManage communications with vendors, suppliers, regulatory officials, and customers regarding all quality-related issues

Manage all food safety requirements of the company in accordance with SQF Code. Ensure the company meets all FDA and USDA regulatory requirements for both the facility and the export of products internationally. Assist the company in all Food Safety and Regulatory audits.

Plano, Texas, United States

Develop and manage the Food Safety and Quality Management System, in accordance with SQF Code

Austin, Texas Area

Boosted prospective membership by 30% by preparing and delivering recurring oral presentations. Increased club membership by 10% through building and maintaining strong personal relationships with new members. Analyzed membership retention data every week to enhance future correspondence and events. Heightened club awareness through daily outreach to cold contacts via phone, text, and email correspondence.

Austin, Texas Area

Designed an experimental method to analyze product composition and increase shelf life. Created 120 FDA nutrition labels through ingredient analysis and calculation.