Engineer, Quality System (Medical Customer)

- Be responsible of customer complain/requirement. Ensure the quality control system do in right way, ensure all countermeasure being implemented and maintained.
- Be responsible of quality system as ISO9001/ISO13485/CSR/EICC/Customer standards.
- Work as QMS coordinator in Plant. Training/Coaching Quality System and Admin, work with related people, sections to response to Customer/3rd party audit. A bridge between the factory and CCS QS team in implementing quality management system improvement projects.
- Handle customer quality claim/requests. Ensure data input into SAP system. Training/Coaching Quality System and Admin, work with related people to Customer quality claim/request response.
- Lead QN task force team, coordinate for QN related actions in Plant and follow up.
- Monitor customer quality performance. Control and improve defect rate, scraps, material consumption, sorting cost. Contact to related departments, sales and customer for quality issue and follow up improvement actions.
- Participate quality meetings in plant and/or with customer and reports. Take part of defect analysis, abnormality report, follow up actions, customer complain and claim, sorting, PFMEA.
- Implement validation, audit, Quality engineering response to Medical customer requirements
- Subordinate performance assessment.
- Clearly understand self's and section's goals to make contribution to obtain quality and delivery goals.