Engineer - Production/ Validation - Injection Molding

• Plan, Coordinate and follow up for validation/ revalidation at TK and Molding section with QM, Production, Planning, Maintenance
• Collect report of Machine Adjustment Card for WCs, Filling Study to be compliant with the Injection SOP
• Co-operate with TK, Molding Team and IPQC team to implement Validation
• Co-operate with project team to implement change control and validation for new mold/new machine
• Do Equipment Risk analysis
• Do Process Risk analysis
• Mold Gap assessment
• Drawing alignment with RD and IPQC
• MDR Process Flow Chart for Component field
• Validation for Blocked Cavity following the Strategy to secure our production
• Responsible for Engineering Test Request from RD or Production before any change
• Follow up the part dimension based of the data provided by IPQC
• Apply new SOP for Cytotoxcity test
• Apply new SOP for sampling size calculation in production.
• Lead for ChC at production included Local change control and global change control.
• Make Deviation Permit if Needed to secure production
• The job function listed is not exhaustive and shall include any responsibilities as assigned by the Supervisor from time to time.