QA Executive

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

We are looking for a motivated and detail-oriented QA Executive to join our Medical Component Department. The successful candidate will be responsible for maintaining and improving quality systems, ensuring product compliance, and supporting quality assurance activities in accordance with applicable ISO 9001 and ISO 13485 requirements.

Job Responsibility:

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.

Job 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.

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Your application will include the following questions:

• What's your expected monthly basic salary?
• How much notice are you required to give your current employer?
• Have you worked in a role which requires a sound understanding of ISO 9001?

What can I earn as a Quality Assurance Executive