- Petaling Petaling Selangor Malaysia
Lokasi Kerja
Penerangan Kerja
Tanggungjawab
Key Responsibilities:
1. Quality Management System (QMS) Maintenance & Compliance:
Ø Manage the development, implementation, and continuous improvement of QMS processes across our organization.
Ø Ensure alignment with relevant standards (such as ISO 9001, IATF 16949, CSR, etc) and other relevant industry standards.
Ø Coordinate and lead internal and external audits, including corrective actions and preventive measures.
Ø Ensure documentation control and timely updates to quality procedures, manuals, and work instructions.
Ø Support risk management activities in accordance with ISO system, ensuring alignment between risk files and QMS processes.
Ø Participate in management reviews by preparing quality metrics, audit results, CAPA status, and improvement recommendations.
Ø Monitor QMS performance using KPIs and drive continuous improvement initiatives.
Ø Support change management activities to ensure changes comply with regulatory and QMS requirements.
Ø Provide QMS and regulatory training to employees to ensure awareness and compliance.
Ø support supplier quality management, including qualification, evaluation, and monitoring of suppliers.
Ø Ensure compliance with customer requirements and regulatory commitments throughout the product lifecycle.
Ø Support and review process validation, equipment validation, software validation, and test method validation in accordance with regulatory and internal requirements.
2. Document Control & Management:
Ø Manage and maintain all documents related to QMS and other compliance frameworks.
Ø Collaborate with various departments to ensure proper documentation and version control.
Ø Develop tracking mechanisms to ensure timely reviews and updates to critical documents.
3. Factory Audits & Inspection:
Ø Conduct factory audits to ensure operational compliance with company policies and standards.
Ø Monitor quality metrics and provide reports with actionable management insights.
Ø Coordinate with cross-functional teams to address non-conformance and initiate corrective actions.
4. Other Management System Maintenance & Compliance:
Ø Implement and maintain workplace safety and health, social responsibility programs in accordance with OSHA regulations, SA8000 management system, applicable local laws and regulations.
Ø Ensure compliance with workplace safety regulations and guidelines, environmental monitoring requirements, and human rights concerns.
Ø Conduct regular inspections, risk assessments, feedback and survey responded to the management system compliance and as per customer requirements.
Ø Manage and update report regularly, including findings from internally and externally, follow up corrective actions to prevent recurrence.
Requirements:
Ø Bachelor’s degree in Manufacturing Engineering, Quality Management, or a related field.
Ø Minimum 2 years of experience in QMS, preferably within a manufacturing environment.
Ø Familiarity with relevant standards (eg, ISO 9001, IATF 16949, ISO 14001, ISO 45001, etc) and other relevant certifications.
Ø Experience in managing internal and external audits, handling customer complaints, and performing root cause analysis with implementation of CAPA.
Ø Strong analytical, communication, and report writing skills, with the ability to work effectively across teams.
Ø Ability to work independently, manage multiple tasks, and meet reporting timelines.
Ø QMS certification such as Internal Auditor Course, Six Sigma or Lean methodologies are the added advantages.
Peringatan Penting
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