衡阳招聘

Main Responsibility

1. Quality management for suppliers under China local legal entity, e.g. medical device, material, service suppliers, 3PL (labeling/warehousing), etc.
2. Medical device/material/service supplier quality management to enable business in compliance with quality/regulatory requirement, incl.

   ？ Supplier and product introduction qualification e.g. on-site/off-site audit, quality agreement, supplier/ product review/approval in internal system

   ？ Supplier performance monitoring incl. change control, quality
   issue handle, periodic assessment, etc.
3. For 3PL (labeling/warehousing) supplier, establish/maintain related SOP, WI, system, record and monitor the execution, in compliance with applicable regulations, global & local quality policy/standard requirement
4. Lead China UDI Implementation in compliance with applicable regulation
5. Continuous improvement for supplier quality management and labeling process
6. Ensure 100% compliance to applicable regulation and internal QMS requirement for what’s responsible for, support for audits e.g. external audit, internal audit as required.

Requirements:

1. Familiar with GMP & GSP regulations, preferrable if manufacturing quality experience in IVD
2. Experienced at interacting with stakeholder from different functions and level
3. Strong problem solving ability and quick learner
4. Capable of English communications in written and oral