QA Executive - Medical Devices (ISO 9001/13485, CAPA)

Sin Yong Guan Industries Sdn Bhd; Ipoh; On-site; MYR 45,000 - 73,000; Full time

Job summary

Sin Yong Guan Industries Sdn Bhd is seeking a motivated QA Executive to join our Medical Component Department in Ipoh. You will maintain and improve quality systems, ensure product compliance, and support QA activities in line with ISO 9001 and ISO 13485 requirements.

The successful candidate will perform CAPA follow-up, handle inspections and testing, review documentation, and collaborate with Production and Engineering to improve product quality and traceability across all stages from incoming

Qualifications

• Diploma in Quality Management, Manufacturing, Engineering, Science or related field required.
• 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, and calibration.
• Good command of English and Bahasa Malaysia, both written and spoken.

Responsibilities

• Conduct systematic reviews of quality systems, procedures and processes.
• Ensure CAPA implementation and follow-up for non-conformities.
• Monitor calibration/maintenance of inspection and measuring equipment.
• Assess, control, and disposition non-conforming products.
• Handle customer complaints, investigate root causes, and corrective actions.
• Liaise with customers on COA/CoC and quality matters.
• Ensure incoming, in-process, and finished products meet specs.
• Maintain quality records for traceability and compliance.
• Support audits and follow-up on findings.
• Collaborate with Production and Engineering to fix quality issues.

Skills

Quality management

ISO 9001 knowledge

ISO 13485 knowledge

CAPA process

Documentation skills

Analytical thinking

Teamwork

English proficiency

Bahasa Malaysia proficiency

Education

Diploma in Quality Management

Bachelor's Degree / Professional Degree

Job description

Sin Yong Guan Industries Sdn Bhd is seeking a motivated QA Executive to join our Medical Component Department in Ipoh. You will maintain and improve quality systems, ensure product compliance, and support QA activities in line with ISO 9001 and ISO 13485 requirements.

The successful candidate will perform CAPA follow-up, handle inspections and testing, review documentation, and collaborate with Production and Engineering to improve product quality and traceability across all stages from incoming