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QMS Executive (Mandarin Speaker)
Kobay Technology BerhadPenangMalaysia, Penang, Malaysia17 jam yang lalu
Penerangan pekerjaanConduct regular internal audits and compliance assessments of manufacturing operations. Identify process risks, gaps, or deviations and initiate appropriate corrective measures. 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). 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. Conduct training sessions for manufacturing staff on compliance protocols, standards, and best practices. Promote a culture of quality and compliance across the organization. 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.
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 :
Non-Compliance Management :
CAPA Implementation :
Training & Awareness :
Subject Matter Expert :
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Executive Mandarin • PenangMalaysia, Penang, Malaysia
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