Generating COC for all medical device outgoing shipments without error.
Generate new Final Inspection Reports for new parts and setup the sampling plan for the based on the procedure.
Lead the team on the product technical testing requirements and acceptance criteria.
Coordination of critical and urgent inspection with Asset Management, lot received and inspection.
Educating and training QA inspectors and leaders on the inspection requirements and methods.
Work with the FQA technician to generate the FQA quality inspection plan.
Verification of the non-conformance and abnormality with engineering, quality & production. Making acceptance and rejection decision based on the customers acceptance criteria.
Raise the Non-Conformance form and drive closure of the non-conformance that occurred at FQA.
Raise the shipment on-hold to contain and constrain non-conforming product shipment.
Compile weekly inspection data into PPM data, daily output, MORV clearance, FQA KPI reports.
Plan the headcount and overtime support based on the production operation plan.
Review and approval of HR related documentation generated by FQA.
Developing and maintaining QA policies and procedures.
Others as per assigned by the Supervisor.
Job Requirements
Degree in Science / Engineering.
At least 3 years of experience in Engineering and or QA functions in manufacturing of medical devices.
Knowledge of using quality tools
Knowledge and hands on experience in leading Quality operations.
Problem solving tools.
Knowledge in manufacturing of medical devices organization.
