Supplier Quality Engineer

RESPONSIBILITIES

Manages a bucket of suppliers and works as main point of contact window between suppliers and Corporate QA and Shanghai Office QA.

Monitors the suppliers’ maintenance of QMS through vigilance audit with primary focus on P&PC and quality control.

Supports/Drives the suppliers to build their own master process validation plan and monitor the execution progress;

Coordinates and manages non-conformities with all related stakeholders and suppliers.

Directs and collaborates with supplier representatives on quality issues (contain but not limit to 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 our volume purchased from them.

Works with broader Quality Organization to establish and maintain supplier ratings and executes the program to improve ratings of suppliers assigned to him/her when needed.

Coordinates the suppliers’ change requests from the initiation to the end, including standardizing the initiation, leading or assisting to review supplier change requests for assessing impact on product quality and QMS, progress communication, etc.;

Transition of QA/QC related knowledge from QE to SQE once the supplier is fully approved for mass production. It includes ensuring the related documents transferring from development to mass production, holding pre-production meeting to align inspection attributes with Medline consistently, and training the QCs (both Medline’s and suppliers’) and production personnel, etc.

Identifies and implements improvement opportunities to increase the efficiency and effectiveness of the supplier quality engineering and supplier quality management programs.

Work with QC/QA to optimize product inspection criteria with LEAN and effective quality inspection purpose.

Completes the other tasks assigned by his/her supervisor or the supplier quality manager.

Qualification

- Education level: Bachelor degree in engineering field;

- 3+ years’ experience on supplier quality management with sound improvement knowledge, working in medical device industry is a plus;

- Good communication skills, both English and Mandarin;

- Team Spirit, Integrity, self-motivated and ready to work under pressure;

- Proven learning and adaption capability.