Quality Engineer

Responsibilities

• Lead quality planning for new projects (NPI), participate in design and development phase reviews, and deliver outputs such as Quality Control Plans, PFMEA, and Critical Quality Characteristics documents to ensure design transfer meets regulatory requirements;
• Monitor production process quality trends, lead root cause analysis for non-conforming products, and drive cross-departmental CAPA closed-loop management;
• Optimize inspection standards (e.g., AQL sampling standards), testing methods, and work instructions (SOP/WI) to enhance inspection efficiency and effectiveness;
• Lead the preparation and implementation of 8D reports for customer complaints;
• Lead the preparation and implementation of 8D reports for customer complaints;
• Lead and develop the QC team, strengthening team building.

Job Requirements

• Bachelor's degree or above in a discipline related to medical devic...