- Pasir Gudang Pasir Gudang Johor Malaysia 81700

Lokasi Kerja
Penerangan Kerja
Kelayakan
Bachelor's Degree in Engineering, Supply Chain Management, Quality Management, or a related field
Minimum 3 years of experience in Supplier Quality Management, Supplier Development, Quality Assurance, or a related role
Hands-on experience conducting supplier audits and managing supplier quality performance
Good understanding of ISO 13485, ISO 9001, quality management systems, and supplier quality processes
Experience working in ISO7 cleanroom environments, including contamination control and cleanroom protocols
Strong analytical, problem-solving, and root cause analysis skill
Excellent communication and stakeholder management skills
Fluent in Mandarin and English (written and spoken) to effectively communicate with suppliers
Willingness to travel up to 50% domestically and internationally
Preferred Qualifications
Experience within the Medical Device, Biotechnology, Pharmaceutical, or Advanced Manufacturing industry
Certifications such as CSQP, Six Sigma, Lean Manufacturing, or other quality-related credentials
Familiarity with supplier qualification, risk assessment, SCAR, CAPA, and supplier performance management
Tanggungjawab
Develop and maintain supplier quality programs to ensure compliance with ISO 13485 and company quality standards
Conduct supplier audits and assessments to evaluate quality systems, manufacturing processes, and cleanroom compliance
Lead supplier qualification, onboarding, validation activities, and quality risk assessments
Drive supplier corrective actions (SCAR), root cause investigations, and CAPA implementation
Monitor supplier performance through KPIs, quality metrics, scorecards, and compliance tracking
Collaborate closely with suppliers to resolve quality issues and drive continuous improvement initiatives
Ensure suppliers comply with ISO7 cleanroom requirements, contamination control, and process validation standards
Partner with Procurement, Engineering, Quality, and Manufacturing teams to align supplier quality expectations with business needs
Travel domestically and internationally to perform supplier audits, resolve issues, and strengthen supplier relationships
Manfaat
Kemahiran
Peringatan Penting
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