Quality Engineer

Responsible for maintaining and optimizing the quality management system, leading the investigation and resolution of internal and external quality issues, managing supplier quality performance, ensuring the integrity of project delivery documents (MDR), and driving continuous improvement projects to enhance product quality and process efficiency.

1. Quality System Maintenance & Optimization · Responsible for the daily maintenance, monitoring, and continuous improvement of the quality management system, ensuring compliance with ISO9001 or other relevant standards. · Assist in organizing internal audits and management reviews and track the implementation of corrective actions for non-conformities. · Update and optimize Quality Department processes, responsibility assignments, and process flow charts according to company development needs. 2. Quality Issue Investigation & Resolution · Lead the investigation and analysis of internal production quality abnormalities and external customer complaints. · Utilize root cause analysis tools (e.g., 5 Whys, Fishbone Diagram, 8D methodology) to develop and verify corrective and preventive actions. · Ensure closed-loop management of all quality issues and prepare comprehensive analysis reports. 3. Supplier Quality Management · Participate in the development and evaluation of new suppliers, establishing supplier quality files. · Handle incoming material quality issues and drive suppliers to conduct root cause analysis and implement improvements. · Regularly evaluate supplier quality performance and drive continuous supplier improvement. 4. Quality Documents & MDR Management · Manage the control of quality system documents, technical documents, and records, ensuring document version validity and traceability. · Lead the collection, review, organization, and archiving of Manufacturing Data Reports (MDR), ensuring documents meet customer and project requirements. · Optimize document management processes to improve document retrieval and archiving efficiency. 5. ITP (Inspection & Test Plan) Development & Implementation · Participate in project pre-technical reviews, understand technical specifications, and develop product and project ITPs. · Review ITP drafts prepared by the Engineering department to ensure the plans are complete and executable. · Supervise the on-site execution of ITPs to ensure effective implementation of quality control points (Witness Points/Hold Points). 6. NCR Process Optimization · Responsible for optimizing the Non-Conformance Report (NCR) handling process to ensure closed-loop management of issue documentation, analysis, correction, and verification. · Promote the statistical analysis of NCR data to identify improvement opportunities and reduce the incidence of non-conformances. · Improve the timeliness and effectiveness of NCR processing, ensuring the process complies with quality system requirements. 7. Continuous Improvement Project Leadership · Lead or participate in cross-departmental quality improvement projects, utilizing tools such as PDCA, Six Sigma, and Lean Manufacturing to drive quality enhancement. · Develop improvement plans for key quality issues or process bottlenecks and track implementation effectiveness. · Promote a quality culture and enhance quality awareness across the organization. 8. IQC Process Optimization & WIP Reduction · Analyze bottlenecks in the Incoming Quality Control (IQC) process, optimize inspection standards and work instructions to shorten inspection cycles. · Drive improvements in incoming inspection efficiency to reduce Work-In-Progress (WIP) inventory and ensure smooth production flow. · Collaborate with Procurement, Warehouse, and other departments to optimize material flow and inspection handover processes.

Education: · Bachelor's degree or above in a Science or Engineering discipline (Mechanical, Materials, Chemical Engineering, or related fields