Job Description

1. 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

1. 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

1. 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

1. 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; easily retrievable for audits

Update specifications, AVL, and procedures to align with latest standards and regulations

Job Requirements

• Responsible for the procurement of electronic components, including common components such as 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 to ensure timely completion of procurement tasks; 
• 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, and adjust procurement strategies promptly to ensure supply chain stability; 
• Assist in handling procurement-related issues and exceptions, with strong external communication skills and the ability to respond and resolve problems efficiently; 
• Be familiar with ERP system operations to ensure accurate procurement data entry and management, and improve information management efficiency.

Skills