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 release6. Manage NCR system for control of non-conforming material7. Ensure effectiveness of CAPA system8. Interface with QA personnel and other various departments concerning quality issues9. Manage supplier quality program and vendor audits10. Approve required certifications for customers11. Responsible for system for calibration of production and testing equipment12. Responsible for revalidation and control of routine sterilization processes13. Responsible for reviewing and evaluation of all biological tests performed on sterile products and controlled environments14. Provide direction and approval of qualifications and initiation of new products15. Provide direction and approval of validations of production equipment16. Ensure company’s risk assessments are performed and managed17. Develop, monitor and report company’s quality objectives or Key Performance Indicators (KPI), and lead Quality Management ReviewsKEY RA DUTIES & RESPONSIBILITIES:1. As management representative, coordinate ISO and customer audits and FDA inspections2. Develop and deploy overall domestic and international regulatory strategies3. Maintain regulatory registrations of all facilities and products with domestic and international agencies4. Provide regulatory support related to change control, documentation and labeling5. Ensure compliance with regulations and laws and manage requirements resulting from new regulations both domestic and international6. Maintain and develop strategies as it pertains to FDA premarket notifications or 510(k)7. Serve as U.S. regulatory representative for international partners

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 and a Quality Engineer. Evolved team responsibilities to include projects and validations.• 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• CAPA Review Board (CRB) contributor• Data analysis and trending for CRB• Change control approver representing Quality Assurance• Certified Internal Auditor• Subject matter expert for NCR and MRB process during audits• Improved and streamlined training for inspectors and technicians• Lead and participated in multiple Kaizens

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 improvements by focusing on systems.• 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• QA Approver for electronic document system

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.