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QMS Executive (Mandarin Speaker)

QMS Executive (Mandarin Speaker)

Kobay Technology BerhadPenangMalaysia, Penang, Malaysia
4 hours ago
Job description

Quality Management System (QMS) :

  • Implement, maintain, and improve QMS processes and procedures in line with industry standards (e.g., ISO 9001, ISO 13485, etc.).
  • Ensure manufacturing activities comply with all relevant internal policies and external regulatory requirements.

Internal Audits & Risk Assessments :

  • Conduct regular internal audits and compliance assessments of manufacturing operations.
  • Identify process risks, gaps, or deviations and initiate appropriate corrective measures.

    • Non-Compliance Management :

  • Lead root cause analysis and investigations of non-conformities, deviations, and product quality issues.
  • Collaborate with cross-functional teams to implement effective corrective and preventive actions (CAPA).

    • CAPA Implementation :

  • Develop, execute, and monitor CAPA plans to ensure timely and sustainable resolution of compliance issues.
  • Track effectiveness of actions taken and ensure closure within defined timelines.

    • Training & Awareness :

  • Conduct training sessions for manufacturing staff on compliance protocols, standards, and best practices.
  • Promote a culture of quality and compliance across the organization.

    • Subject Matter Expert :

  • Serve as a key resource for compliance-related inquiries, audits, and improvement initiatives.
  • Support external and customer audits by providing necessary documentation and process walkthroughs.
  • Any ad hoc tasks assigned by management or company.

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    Executive Mandarin • PenangMalaysia, Penang, Malaysia