Quality Engineer

Company Description
We are an established ISO 13485 Certified Medical Device Manufacturing Company. We specialize in the manufacture and assembly of plastic injection-molded and extruded components for medical applications.
Job Responsibilities
1. 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;
2. Monitor production process quality trends, lead root cause analysis for non-conforming products, and drive cross-departmental CAPA closed-loop management;
3. Optimize inspection standards (e.g., AQL sampling standards), testing methods, and work instructions (SOP/WI) to enhance inspection efficiency and effectiveness;
4. Lead the preparation and implementation of 8D reports for customer complaints;
5. Lead the preparation and implementation of 8D reports for cu...