What You Will Do In Your Role
- Create and maintain PPAP packages—APQP, PFMA, control plan, SPC, MSA, ect., and submit to customer for approval.
- Create all Quality plan/Inspection instruction for products, and perform the training to the responsible person.
- Create the SPC method for process control, and perform the training to the responsible person.
- Create all the record templates for the product inspection activities.
- Conduct the validation protocol creation and execution.
- Customer compliant handing, lead root cause analysis and implement improve action and prevent action, finish 8D or CAPA report and review with customer.
- Support plant continuous improvement/scrap reduction project.
- Other duties as assigned by supervisor.
The Experience You Will Bring
- 3-5 years working experience in medical device or pharmaceutical manufacturer.
- Experienced in validation process .
- Induvidually handle new project quality plan set up and validation protocol creation.
- Knowledge in ISO9001/ISO 13485/GMP.
- Knowledge of FMEA/SPC/QC 7 tools/8D.
- Good communication skills.
- Strong problem solving skills.
- Good analytic senses.
- Flunt English both in written and oral.
What Will Put You Ahead
- Be familiar with measurement equipments.
- Be familiar with the high-automation assembly process.
- Experience in Software validation.