Job Description
Position Summary
Principal Responsibilities
1. Take part actively in coordinating internal audit and external audit.
2. Establish and control the internal audit plans and internal audit schedules as per internal requirements.
3. Maintain the audit files according to the procedure.
4. Ensures the integrity of the company's Quality Management System in compliance to ISO 13485, MDSAP, MDD or EU MDR and other Regulatory requirements.
5. Participate as a lead/ internal auditor during internal audit.
6. Act as NC initiator for all internal NC issued on internal audit findings.
7. Monitor nonconformance which initiated from internal and external audit and ensure timely reporting and closure.
8. Coordinate in external quality system audits to ensure the fulfilment of the requirements of ISO 13485, MDSAP, MDD or EU MDR, and GDPMD, and other relevant regulatory requirements and international standards.
9. Maintain the records of the competency of internal auditors.
10. Ensure latest global procedure is effectively implemented on site.
11. Undertake effective OSH measures to ensure compliance within the workplace with the Occupational Safety and Health Act 1994 and other legislative requirements.
12. Data Integrity Oversight:
• Monitor systems, processes, and documentation to ensure data integrity compliance.
• Coordinate/ conduct training and awareness initiatives for staff to ensure understanding and compliance with quality standards and data integrity practices.
13. Standard and Regulatory Monitoring:
• Stay current with applicable regulations/guidelines regarding quality audits and data integrity.
• Maintaining standard and regulation watchlist. Meeting cadence for Technical Review Board (TRB) Meeting for Standard & regulation monitoring.
• Monitoring the overall remediation activity of the watchlist for standards in all product families. Provide support in retaining the latest standard updates impacting Kamunting site and ensure gap assessment is in place for all standard revisions.
14. And any other assignment/ task deemed fit.
Education / Experience Requirements
Qualification :
Degree in Science or Engineering related field or Equivalent
Experience :
Experience and knowledge Quality system requirements.
Good understanding in EN/ ISO13485, FDA QSR and MDD or EU MDR
Computer skills in Microsoft Office – at least at basic level for Word, Excel and Power Point
Good spoken and written English
Able to work independently with minimum supervision.