Responsible as a Self-Inspection Coordinator including planning, scheduling, execution, reporting and follow-up of self-inspection audit. Ensure self-inspection audits are conducted as per Quality Systems requirements.
Coordinate internal and external QMS audits, such as Corporate, Health Authority and Notified Body.
Support external supplier audit.
Act as a Site Coordinator of TrackWise-Ace system. Ensure self-inspection/ supplier audit report is closed timely and effectiveness of correction/ preventive actions.
Provide training and qualification of self-inspection auditor.
Act as a Site Representative in Global Audit Community.
Responsible for Management Review and Quality Council Meeting, including schedule, follow-up actions and minute of meeting.
Update and follow-up Compliance Tracker.
Involve in quality compliance improvement program.
Support IMPACD and External Standards process.
Involve in the product recall, FAA, and mock recall when required.
Act as a NCR/ CAPA Site Coordinator, local administrator and trainer of TrackWise-Global CAPA system.
Conduct periodic review of NCR/ CAPA trends, analysis and provide feedback for the effectiveness of correction/ preventive actions.
Working in accordance with the HSE Manual and documented procedures, and reporting HSE issues to the respective area
owners.
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