Quality Engineer (Calibration & Supplier Management)

Summary

Responsible for managing the calibration program and supplier management processes to ensure compliance with ISO 13485 and other regulatory requirements. This role involves working with internal teams and external suppliers to maintain quality standards and continuous improvement in calibration and supplier management.

Job Responsibilities

• Establish and maintain calibration program for measuring and testing equipment.
• Ensure all calibration activities comply with ISO 13485, ISO 17025 and internal requirements.
• Schedule and coordinate internal and external calibration services.
• Review calibration reports and investigate out-of-tolerance (OOT) conditions.
• Maintain calibration records and ensure proper documentation in the QMS system.
• Conduct supplier evaluations, audits and qualification processes.
• Work with suppliers to resolve nonconformances (SCARS) and deviations.
• Ensure suppliers comply with ISO 13485 and regulatory standards.
• Promote quality awareness on calibration procedures and supplier management best practices.
• Perform any other related duties as assigned by immediate superior.

Qualifications

1. Education level: Minimum Bachelor's degree in Science or Engineering (or any relevant discipline).
2. Year of Experience: Minimum one (1) year experience in manufacturing.
3. Capability: Effective communication skills.
4. Skills: Possess knowledge of ISO 13485, general calibration and supplier management.
5. Language: English and Bahasa Malaysia are must. Others will be an added advantage.