Supplier Quality Engineer
2 weeks ago
Core Job Responsibility: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.
Basic 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.
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.
Core Competency (MSF):Sense of urgencyStrong work ethicDeliver resultsFocus on the customerSound judgementBuild effective relationships
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