Quality Assurance Executive

Sin Yong Guan Industries; Ipoh; On-site; MYR 33,000 - 56,000; Full time

Job summary

Sin Yong Guan Industries in Ipoh is seeking a dedicated Quality Assurance professional to perform systematic reviews of quality-related systems, ensure CAPA implementation for non-conformities, and supervise calibration and inspection of materials and finished products.

You will liaise with Production and Engineering to resolve issues, maintain complete quality records for traceability, support internal and external audits, and contribute to continuous improvement initiatives.

Qualifications

• Diploma in Quality Management, Manufacturing, Engineering, Science or related field.
• Bachelor’s/Professional degree in related field an added advantage.
• Knowledge of ISO 9001 and ISO 13485 preferred.
• Familiarity with QA/QC, inspection, CAPA, non-conformance management, calibration.
• Good command of English and Bahasa Malaysia, written and spoken.
• Strong analytical, problem-solving, communication and documentation skills.
• Detail-oriented, responsible, able to work independently or in a team.
• Fresh graduates encouraged to apply.
• Experience in medical devices, medical components, manufacturing, or QA/QA will be advantageous.

Responsibilities

• Conduct systematic and regular reviews of quality-related systems, procedures, and processes.
• Ensure effective CAPA implementation for non-conformities and follow-up.
• 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 root cause analysis.
• Liaise with customers on quality matters, concessions, COCs and COAs.
• Ensure incoming, in-process and finished products meet specifications and approvals.
• Maintain accurate quality records for traceability and compliance.
• Support internal and external audits with relevant documentation and follow-up.
• Assist in monitoring quality performance and driving continuous improvement.
• Collaborate with Production, Engineering, and other departments to resolve quality issues.

Skills

Quality management

CAPA

Documentation

Analytical skills

Education

Diploma in Quality Management / Manufacturing / Engineering / Science

Bachelor's Degree / Professional Degree (added advantage)

Tools

ISO 9001

ISO 13485

Job description

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• 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.