Quality Assurance Executive

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

Key Responsibilities

• Conduct systematic and regular reviews of quality-related systems, procedures, and processes.
• Ensure effective implementation and follow-up of Corrective Action / Preventive Action (CAPA) for non-conformities.
• Monitor and ensure all inspection, testing, and measuring equipment are properly calibrated and maintained.
• Assess, control, and disposition non-conforming products in accordance with established procedures.
• Handle and follow up on customer complaints, including investigation, root cause analysis, and corrective actions.
• Liaise with customers on quality-related matters, including concessions, Certificates of Conformance (COC), and Certificates of Analysis (COA).
• Ensure incoming materials, in-process products, and finished products are inspected according to established specifications and procedures.
• Ensure products meet applicable quality requirements and are properly approved before release and delivery.
• Maintain accurate and complete quality records and documentation to ensure product traceability and compliance.
• Support internal and external audits, including preparation of relevant quality documentation and follow-up on audit findings.
• Assist in monitoring quality performance and implementing continuous improvement initiatives.
• Work closely with Production, Engineering, and other relevant departments to resolve quality issues and improve product quality.

Requirements

• Candidate must possess at least a Diploma in Quality Management, Manufacturing, Engineering, Science, or a related field.
• Bachelor's Degree / Professional Degree in a related field will be an added advantage.
• Knowledge of ISO 9001 and ISO 13485 is preferred.
• Familiarity with quality assurance, quality control, inspection, CAPA, non-conformance management, and calibration processes is an advantage.
• Good command of English and Bahasa Malaysia, both written and spoken.
• Strong analytical, problem-solving, communication, and documentation skills.
• Detail-oriented, responsible, and able to work independently as well as in a team.
• Fresh graduates are encouraged to apply.
• Candidates with relevant experience in medical devices, medical components, manufacturing, or quality assurance/control will have an added advantage.