Job Description
Location: Bayan Lepas, Penang
Job Descriptions
- Apply quality engineering principles to analyze quality records, prepare reports, and recommend process or product improvements.
- Conduct inspection, verification, and validation of components or materials used in development and production processes.
- Identify and address recurring quality issues related to product performance.
- Document quality issues, non-conformances, and performance metrics for management review and continuous improvement initiatives.
- Support root cause analysis and corrective/preventive actions (CAPA).
- Assist in maintaining compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulatory requirements.
- Participate in internal audits and support external audits as needed.
- Collaborate with engineering, manufacturing, and supply chain teams to ensure product quality and reliability.