Supplier Quality Engineer

Responsibilities

• Manages a bucket of suppliers and acts as main point of contact between suppliers and Corporate QA and Shanghai Office QA.
• Monitors suppliers’ maintenance of QMS through vigilance audits with primary focus on P&PC and quality control.
• Supports and drives suppliers to build master process validation plans and monitors execution progress.
• Coordinates and manages non-conformities with all related stakeholders and suppliers.
• Directs and collaborates with supplier representatives on quality issues (including complaints, rejections, findings), ensures timely corrective action implementation (CAPA and SCAR) and contributes to supplier quality improvement programs.
• Works with suppliers on CAPA follow-ups as results of QSR and SA (social accountability) audits.
• Keeps track of suppliers' overall capacity and the purchase volumes from them.
• Works with the broader Quality Organization to establish and maintain supplier ratings and executes programs to improve supplier ratings when needed.
• Coordinates suppliers’ change requests from initiation to closure, including standardizing initiation, reviewing change requests for impact on product quality and QMS, and communicating progress.
• Transitions QA/QC related knowledge from QE to SQE once a supplier is approved for mass production, including document transfer, holding pre-production meetings, and training QCs and production personnel.
• Identifies and implements improvement opportunities to increase efficiency and effectiveness of supplier quality engineering and management programs.
• Works with QC/QA to optimize product inspection criteria using LEAN principles for effective quality inspection.
• Completes other tasks assigned by supervisor or the supplier quality manager.

Qualifications

• Bachelor degree in engineering field.
• 3+ years’ experience in supplier quality management with strong improvement knowledge; experience in the medical device industry is a plus.
• Experience with audits, CAPA, SCAR, QMS and supplier change control.
• Good communication skills in both English and Mandarin.
• Team spirit, integrity, self-motivated and able to work under pressure.
• Proven learning and adaptation capability.

Additional Information

• Work arrangement: onsite.
• Employment type: contract (daily).