Responsibilities
Lead project team on new project quality improvement before mass production
Participate new products trail run, follow the products quality and gave personal advices from quality view.
To be quality contact window with customer on new project quality, Lead new project gate review and quality risk assessment
Establish the requirements of measurement & testing and follow up the implementation, include appropriate SPC control, Data collection and analysis management
Review product manufacturing environment requirements. Setup visual specifications, including sampling plan of Incoming inspection (IQC), In-process inspection (IPQC) and Final Inspection (PSA)
Lead to resolve customer quality issues, analyze and handle material quality issue and follow up corrective action.
Supervise and evaluate suppliers of quality performance monthly and yearly audit supplier，push suppliers to improve their performance.
Evaluate and qualify new suppliers with Purchaser and Engineering
Issue NCR (MRB) or SCAR report and follow corrective action.
Audit the production line according to audit plan.
Establish, maintain and improve the work instruction, inspection check list and training to inspectors
Participate in Validation process and Internal Audit according to ISO 13485.
Analyze and handle material quality issue from production line ensure production goes smoothly, supervise suppliers' quality performance, push suppliers to improve their performance, evaluate supplier's performance monthly and yearly audit supplier.
CME & CDA validation, CME & OFA monthly monitoring and report.
Prepare all Quality report, FAI report and ORD inspection report
Qualification
Male/Female age 25-35 years old
Bachelor degree in Engineering or Science.
Above 5 years relative work experience in QC/QA
Knowledge of QC-7tools, PFMEA, APQP, PPAP, 8D, SPC, 5Why, etc.
Knowledge of ISO 13485, ISO 14971 will be advantage.
Can use the basic measurement device
Good command of English in communication
Good command of MS office software application
