Product Quality Engineer
Current● Lead the implementation of switching sampling plan under ISO-2859-1 from Normal Inspection to Reduced Inspection to maintain supply continuity of final device for 12 months.● Lead a process improvement project to automate Quality Management View on SAP BPM system to reduce cycle time from 30 minutes to 10 minutes due to process automation.● Lead successful implementation of launching Final Assembly Machine for Quality Control with appropriate with Process Failure Mode Effect Analysis (P-FMEA) document from scratch for newlybuild site production in Charleston, South Carolina, USA.● Lead an improvement project to reduce Quality Control’s workload by providing justification to remove component function tests for several projects using Functional Analysis method.● Contribute to the development of an internal Guideline to ensure that the project team identifies potential failure modes through risk factors during process development activities.● Construct new method for task prioritization by introducing Microsoft Planner for better agility, task coordination, and project’s tracking with co-workers to improve working efficiency and traceability.● Participate in relevant Post-Process Development Lifecycle activities such as Customer Complaint, NonConforming Material Report (NCMR), Change Control, and Deviation Meeting to provide/collectinformation and ensure risk identification, risk mitigation, and risk control are well managed and consistent through P-FMEA and Risk Management File to comply with ISO 14971:2019.