Primary Purpose:
To ensure all validation and quality control activities are compliant with the regulatory requirement, customer requirement, and internal QMS requirement in new product introduction phase.
To ensure all products and process quality can meet Product Specification.
Core team member of a project during project launch phase.
Duties& Responsibilities
1. Create and maintain PPAP packages-APQP, PFMA, control plan, SPC, MSA, etc., and submit to customer for approval.
2. Lead medical project process validation and verification and comply with global validation requirements. Create all the related new project validation protocol, reports and align with customer.
3. Create all Quality plan/Inspection instruction for products, and perform the training to the responsible person.
4. Create the SPC method for process control, and perform the training to the responsible person.
5. Create all the record templates for the product inspection activities.
6. Change, nonconformance and deviation handling
7. Customer compliant handing, lead root cause analysis and implement improve action and prevent action, finish 8D or CAPA report and review with customer.
8. Support plant continuous improvement/scrap reduction project.
9. Follow EHS related laws, regulations and company's EHS related management regulations, timely report potential risk, and propose safety improvement suggestions; For management position, be responsible for EHS management of the department/team.
10. Other duties as assigned by supervisor.
Requirements:
Bachelor or above degree. Major in Mechanical Manufacture and Production Engineering Technology.
Knowledge in ISO13485 and QSR 820.
Good communication skills, fluent English both in written and oral
Good analytic senses
Good computer skills, be familiar with EXCEL, WORD, and PowerPoint.
1-2 years experiences in a Quality Engineering filed in a molding, automotive or electronical company.
