Sam Yu Email & Phone Number

Lake Forest, CA, US

Santa Ana, CA, US

KEY QA DUTIES & RESPONSIBILITIES:1. Manage entirety of document control functions to ensure all changes are controlled2. Provide direction and approval of any changes to the DMR and DHR3. Responsible for review and approval of Design & Development changes4. Manage system for customer complaints5. Manage system for receiving inspection and finished goods.

• Quality Control/Quality Assurance SupervisorKavo Kerr, Orange, CA, 2016 – PresentHired as QC supervisor of a team of 5 QC inspectors and quickly expanded responsibilities to a head count of 8 to include QA Specialists.
• Overhauled non-conformance/variance report procedures
• Decreased total and aging NCR inventory
• Monthly data analysis of NCRs through trending and PSP
• Increased collaboration across manufacturing sites including international
• Lead Material Review Board

Bethlehem, PA, US

• Quality Systems AnalystB. Braun Medical, Irvine, CA, 2014 - 2016Promoted to an Analyst after 3 years as a laboratory technician for ability to spot gaps in processes and documentation. Specialized in quality.
• Owner and successfully closed 2 CAPAs
• Ran 4 recalls including periodic FDA updates and closure
• Tracking and closure of over 40 internal/external audit observations
• Metrics and trending of NCR and Complaint systems
• Monitored and provided metrics for Preventive Maintenance, Change control, and Supplier Corrective Action Notices

Bethlehem, PA, US

• QC Laboratory Associate IIB. Braun Medical, Irvine, CA, 2011 - 2014
• In process and finished good testing through analytical chemistry instruments and wet chemistry (HPLC, TOC, UVVIS, pH, titrators)
• Record data in LIMS, SAP and notebooks, environmental monitoring of labs, audits, supply and standard maintenance.