QA Engineering Mgmt 4

Job Description
Duties of Position: (Include specific duties and responsibilities)

• Responsible for all product quality issues including managing internal and external communication on product qualities.
• Identification on-going issues and makes recommendations to improve current processes.
• Interface with customers and operational groups on quality related issues.
• Manage plant wide Quality System in accordance to the ISO requirement to improve and maintain QMS suitability and remain effective.
• To be Quality Management Representative
• Responsible to host FDA inspections, facilitate response to 483 and warning letter when the needs arises.
• Deliver target RMA goals per customer & site requisitions.
• Establish medical customer validation requirement interns of Master Validation Plan and execution of IQ/OQ/PQ.
• Review and approve the Deviation / Quality Alert / Purge Notice /NCMR/ Stop Build and Stop Ship <...