Engineer Supplier Quality (SQE)

JOB SUMMARY
Takes full ownership in managing overall quality performance of supplier assigned including maintenance of QMS and meeting our Quality Metrics.
Works cross-functionally with internal and external customers to ensure the supplier quality continuously meeting Medline quality requirements;
Participates in activities to develop supplier quality system, product quality, manufacture process and category quality strategy.
CORE JOB 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.
JOB REQUIREMENTS
Qualification
Education level: Bachelor's degree in engineering field;
3+ years' experience on supplier quality management with sound improvement knowledge,
Have experience in managing suppliers in medical device / plastic manufacturing, specifically with plastic injection molding
Good communication skills both English and Vietnamese;
Team Spirit, Integrity, self-motivated and ready to work under pressure;
Proven learning and adaption capability.
Technical Skills
Familiar with MS office software applications like MS Word, Excel and PowerPoint;Good data analysis skills, utilizing data to dig up and solve problem;
Familiar with quality tools, such as 5WHY, Fishbone, SOP etc. Lean & Six Sigma project experience is a plus;
Familiar with ISO 9001, internal auditor or knowledge of ISO 13485/QSR 820 is a plus.
Having SQE experience, complaint handling, CAPA, Supplier scorecard.