Haewook Lee Email & Phone Number

Los Angeles, California, United States

Greater Chicago Area

- Lead cross functional team on key quality activities including complaints and nonconformance management (Bracketing and Containment, Root Cause Analysis, CAPA, 8D, Six Sigma), change management and implementation at Abbott site and vendor site (equipment change/addition, QC change/addition, new facility addition, QMS change, PCN), vendor selection, and vendor audits.- Validate and qualify vendor parts via Process Characterization, Tool Qualification, IQ, OQ, PQ, FAI, and ensuring quality controls and standards at vendor sites adhere to ISO13485 and ISO9001.- Ensure good documentation practices on all quality complaints and nonconformance, change management and implementation, audits, and validation activities to adhere to ISO 13485 and FDA requirements.- Regularly present to senior leadership on key quality issues, product expansion projects, continuous improvement projects, and statistical analysis of key quality metrics.

- Program manage the issues to resolution team in prioritizing and resolving customer issues experienced in the field. - Coordinate with manufacturing, vendors, development, commercial marketing in providing failure analysis and drive corrective actions and preventive actions (CAPA) to customers regarding product issues experienced at customer sites.- Regularly present reports to management and senior leadership showing statistical analysis of the quality department to request actions from management to drive continuous improvement of quality operations.

5th Rotation -Quality Data Systems- Created a strategic accounts customer dashboard to increase customer awareness and identify risks using SPC to take proactive actions to prevent major issues at strategic accounts. - Created live reporting of root cause failure analysis using Power BI and connecting to the SQL database and SAP, facilitating actions to resolve open failure analysis. 4th Rotation -Field Quality Engineer - Project managed investigations with sales and corporate teams to drive CAPA and solve product related issues experienced by customers.- Digitized the root cause failure analysis request process, creating a more customer friendly interface and at the same time enhance the collection of failure information for the product engineers to perform the failure analysis.3rd Rotation - Supplier Quality Engineer (Electronics) - Managed PPAP (Production Part Approval Process) and drove CAPA on non-conforming parts for the electronic components (diodes, capacitors, resistors, transistors, IC) by working with vendors and sourcing.- Identified high risk parts and mitigated risks of non-conforming parts for the new product introduction project. 2nd Rotation - Engineer in Training / Field Support Engineer - Developed technical skills required to understand and troubleshoot Rockwell Automation’s hardware and software.- Demonstrated the ability to provide solutions with Rockwell Automation’s integrated architecture. - Troubleshoot and solved controllers, and drives issues experienced at customer sites. 1st Rotation -Product Quality Engineer (Motion Control) - Collaborated across business functions to investigate, analyze, and provide solutions on product problems with servo drives & motors to customers. - Supported the quality process that provides root cause failure analysis to customers on servo drives & motors.- Reduced Q1 FY17 PPM average of 24 hour returns for servo drives & motors in EMEA region by 23% by Q3 FY17.

- Saved $180,000/year and produced additional 900 parts/day by optimizing resources and eliminating waste- Developed new hire training for the operators to be used throughout the plant

- Developed a material tracking mechanism using Excel to easily keep track and identify the distribution of materials- Conducted capability studies on automotive lamps and reduced variations in part specification by 60%

- Reduced variations and cycle time for pump assembly by improving material flow, producing additional 200 parts/day- Created error proofing bypass instructions for accurate standard instructions and documentations- Utilized SPC (statistical process control) and gage R&R to ensure quality of parts.- Created standard work instructions and documentations for the pump assembly.