Location
bayan lepas, penang, Malaysia
Posted
June 04, 2026
Job Description
The Quality Systems Engineer I supports the administration, monitoring, and continuous improvement of the global QS program across all sites. This role ensures compliance with applicable standards, regulatory requirements, and internal procedures.
- Assist in maintaining and improving the QMS.
- Support compliance with FDA, ISO 9001, 13485, AS9100 and other applicable standards/regulations.
- Participate in document control activities and change control processes.
- Support all types of audits (external and internal).
- Support all phases of Corrective Action and/or Preventive Action (CAPA).
- Track and report on CAPA status.
- Assist, Support and Maintain risk management documentation.
- Support employee training compliance.
- Collect and analyze quality metrics (KPIs).
- Prepare reports on Audit results, CAPA trends, Customer complaints, Process performance.
- Collaborate with Complaint ...