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- Serve as the appointed QMR for ISO 13485 compliance.
- Develop, implement, and improve the Quality Management System (QMS), including establishing quality standards and ensuring proper documentation and control.
- Oversee the QA team to ensure products meet regulatory, company, and customer requirements.
- Set and optimize inspection standards for incoming materials, in-process controls, and finished goods, ensuring compliance with quality specifications.
- Drive continuous improvement based on findings, customer complaints, and corrective actions.
- Approve quality system documents, CAPA closures, and nonconformity resolutions.
- Contribute to performance improvement initiatives and collaborate with engineering and procurement on supplier quality management.
- Manage internal and external customer complaints, ensuring effective communication and resolution.
- Conduct internal audits and participate in management reviews for quality improvements.
- Provide training to enhance quality awareness across the organization.
- Manage and ensure compliance with customer and external audits.
Job Type: Full-time
Pay: Up to RM18,000.00 per month
Schedule:
- Monday to Friday
Experience:
- ISO13485: 5 years (Preferred)
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