Quality System Associate Port Klang / Pontian

Role Responsibilities

• Acknowledge and respond to customer complaints within the defined timelines, utilizing Complaint Investigation Reports (CIR), Corrective and Preventive Actions (CAPA), or other relevant tools.
• Ensure that the handling of customer complaints complies with international standards, regulatory requirements, and customer agreements.
• Ensure all quality system documents are properly maintained and updated in compliance with international standards, regulatory requirements, and customer agreements.
• Manage document revision to maintain the integrity, accuracy, and security of master documents.
• Monitor and follow up with relevant parties on gap analyses related to new regulatory or standard updates to ensure continued compliance.
• Assist the Quality Management Representative (QMR) in preparing and conducting management review meetings as required.
• Review and report to the Group Quality Manager on potential medical device recalls or reporting needs arising from customer complaints or identified non-conformances.
• Perform any other duties or tasks as assigned by the Head of Department (HOD).

Role Requirements

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We regret that only shortlisted candidates will be notified.

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