Purchasing Officer

Sourcing & Supplier Management (ISO 13485 Compliant) - 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 Procurement Process & Control - 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 Compliance & Quality (ISO 13485 Focus) - 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 Document & Record Control - 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 - Update specifications, AVL, and procedures to align with latest standards and regulations Requirements - Responsible for the procurement of electronic components, including resistors, capacitors, inductors, diodes, transistors, integrated circuits (IC), etc. - Independently manage the procurement process for PCBA product BOMs, including BOM quotation, purchase order follow-up, and order tracking - Develop and maintain sourcing channels for electronic components, optimize procurement costs, and improve purchasing efficiency - Monitor electronic component market trends, price fluctuations, and lead time changes - Assist in handling procurement-related issues and exceptions - Be familiar with ERP system operations to ensure accurate procurement data entry and management