QA & Compliance Lead – Medical Devices

Sin Yong Guan Industries Sdn. Bhd.; Ipoh; On-site; MYR 33,000 - 67,000; Full time

Job summary

Sin Yong Guan Industries Sdn. Bhd. in Ipoh, Malaysia is seeking a Quality Assurance professional to oversee quality systems, CAPA, and calibration activities.

The role involves handling non-conformances, customer complaints, and ensuring products meet specifications before release. The ideal candidate will have a Diploma in quality-related fields, with a Bachelor's degree preferred, and strong English and Bahasa Malaysia communication skills.

Qualifications

• Diploma or higher in quality-related field; fresh graduates welcome.
• ISO 9001 and ISO 13485 knowledge preferred.
• Familiarity with QA, quality control, inspection, CAPA, non-conformance management, and calibration processes.
• Good command of English and Bahasa Malaysia, both written and spoken.
• Strong analytical, problem-solving, communication, and documentation skills.
• Detail-oriented and able to work independently or in a team.

Responsibilities

• Conduct regular reviews of quality-related systems, procedures, and processes.
• Ensure CAPA implementation and follow-up for non-conformities.
• Monitor calibration and maintenance of inspection, testing, and measuring equipment.
• Assess, control, and disposition non-conforming products per procedures.
• Handle customer complaints including investigation and corrective actions.
• Liaise with customers on quality matters, concessions, COC, and COA.
• Ensure incoming materials, in-process, and finished products meet specs.
• Ensure products meet quality requirements and are approved before release.
• Maintain accurate quality records for traceability and compliance.
• Support internal and external audits and follow-up on findings.
• Assist in monitoring quality performance and continuous improvement.
• Collaborate with Production and Engineering to resolve quality issues.

Education

Diploma in Quality Management, Manufacturing, Engineering, Science, or related field

Bachelor's Degree / Professional Degree in related field

Job description

Sin Yong Guan Industries Sdn. Bhd. in Ipoh, Malaysia is seeking a Quality Assurance professional to oversee quality systems, CAPA, and calibration activities.

The role involves handling non-conformances, customer complaints, and ensuring products meet specifications before release. The ideal candidate will have a Diploma in quality-related fields, with a Bachelor's degree preferred, and strong English and Bahasa Malaysia communication skills.