Quality Assurance Lead

4 days ago


Ipoh, Perak, Malaysia Plaxtron Industrial (M) Sdn Bhd Full time
Job Summary:

The QA Manager will oversee the Quality Management System (QMS) to ensure compliance with ISO 13485, FDA, and other regulatory requirements. This includes developing, implementing, and maintaining quality policies, procedures, and risk management strategies.

Key Responsibilities:
  • Lead audits (internal/external) and ensure CAPA (Corrective and Preventive Actions) are effectively implemented.
  • Manage document control, validations, and change control processes.
  • Provide training and guidance on quality standards and regulatory compliance.

Requirements:
  • Diploma or Degree graduate.
  • Minimum 1 year or more of experience in quality assurance roles.
  • Have held a related position within the company (engineering, production, warehouse, purchasing, sales) for at least 1 year and be familiar with the company's product characteristics as well as quality assurance-related system processes.


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