- Prai Pulau Pinang Malaysia

Working Location
Job Description
Requirements
Responsibilities
Identify, evaluate, and select suppliers based on medical industry standards and regulatory requirements
Perform supplier qualification, audit, and re-evaluation; maintain Approved Supplier List (AVL) with full records
Ensure suppliers have relevant certifications: ISO 13485, ISO 9001, RoHS, REACH, or medical approvals as required
Negotiate contracts and Quality Agreements that define medical-grade requirements, traceability, and responsibility
Monitor supplier performance: quality, delivery, compliance, and capability; conduct periodic audits
Develop alternative sources to reduce supply risk; ensure suppliers follow design control and change control rules
Receive material requirements, MRP, or purchase requests; verify specification matches medical product standards
Issue Purchase Orders (PO) with clear technical specifications, quality standards, regulatory requirements, and traceability needs
Ensure all purchasing documents include: part number, revision, material grade, compliance statement, and batch/lot requirements
Follow up delivery; confirm batch numbers, manufacturing dates, and certification documents accompany every shipment
Manage lead time, stock level, and safety stock to avoid shortage; ensure no unapproved material substitution
Handle urgent orders and shortages without compromising quality or compliance
Strictly follow ISO 13485 clauses: Purchasing process, supplier control, product realization, traceability, and document control
Ensure all purchased materials meet medical device safety, performance, and regulatory requirements (e.g., MDD, MDR, FDA)
Work closely with Quality & Engineering to validate materials for medical use; participate in incoming inspection and qualification
Manage Engineering Change Notices (ECN/ECR); ensure changes are approved, documented, and do not affect product safety or compliance
Maintain full traceability: link purchase orders, batches, suppliers, and usage in production
Ensure all materials are RoHS/REACH compliant and free from prohibited substances
Keep complete, accurate, and traceable records: supplier audits, evaluations, contracts, POs, delivery notes, certificates, and test reports
Ensure all purchasing records are retained per legal and ISO 13485 requirements; easily retrievable for audits
Update specifications, AVL, and procedures to align with latest standards and regulations
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