Job Responsibilities

1. Responsible for quality planning in new project development: standardizing quality management for projects/R&D processes and developing quality management documents (QMP/REL Test Plan/QCP/MSOP) for project/R&D phases, ensuring end-to-end consistency and compliance. 2. Responsible for following up on trial mold samples during the new product development process from project initiation/EVT/DVT/PVT/MP stages, collecting issues, confirming samples, and reviewing and outputting related quality documentation (e.g., CPK/FAI/REL YIELD Report); driving the PDT team to address issues and ensure closed-loop management. 3. Responsible for confirming Gold samples, submitting PPAP documents for customer review alongside engineering personnel; reviewing supplier samples and approval documents (QE approval for appearance, engineering approval for structure), and confirming both internal and supplier sample approvals; collecting appearance limit samples and confirming with customers; signing off and distributing internal samples. 4. Responsible for pre-production training. 5. Responsible for following up on and improving customer complaints throughout the product lifecycle, participating in process yield enhancement, and assisting in major issue analysis; managing customer relations and maintaining connections.

Job Requirements

1. Fluent spoken English, able to communicate effortlessly with American customers. 2. Familiar with the ISO13485 system, with quality management experience in Class II medical product companies, and involvement in the full process of quality planning and control for medical product design conversion (from initiation to EVT-DVT-PVT-MP). 3. At least 3 years of quality work experience in Class II medical (contract manufacturing).

Required Languages

English