QA Executive

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.
• 2 positions available (Ipoh & Simpang Pulai plant).