Job Responsibility- Supervise inspection and test activities on incoming, in process and outgoing product to ensure smooth operation of daily routine.
- Supervise QA inspectors to ensure smooth operation of daily routine. e.g. MRR closure and CAPA as per targeted dateline.
- Manage Material Review Report for completion and closure.
- Responsible in supplier non-conformance complaint (SCAR) and Customer Complaint (CCAR). Verify the corrective and preventive actions for CAPA closure.
- Conduct process and product online audit.
- Perform calibration of test, inspection and measurement equipment.
- Perform duty according to quality procedures and standard operating procedures to comply with ISO 13485 requirements.
- Maintain Document, Form & Record. Establish and update form, WI, QP, SOP related to process and inspection
- Particle count monitoring. Perform monthly particle count measurement and every time after plant shut down.
- Shift arrangement for QA inspectors to follow production schedule.
- Conduct AAA test for QA Inspectors & operators.
- Participate in product and machine validation.
- Perform test method validation.
- Training of new quality and/or production staffs. Participate in inspectors and operator's certification and re-certification activities.
- Perform duties as assigned by the superior.
Job RequirementsJob Benifits