- Responsible for Quality Management in compliance with regulation and company Quality requirements (e.g., FDA QSR, ISO 13485, KR Medical Device Act), including rolling out Global SOP. Oversee Quality system performance. Collaborate with local team and participate in audit program, Quality training program and CAPA program to ensure successful achievement of Quality objectives.

- Lead all preparation and communications with internal and external parties. Provide guidance to the business on Quality issues (e.g., NPI, Process change, Quality awareness, Customer inquiry, regulator’s enquiry)

- Support in the complaint management process (sample return, follow up with sales etc.)

- Warehouse Quality Management

b)Implement and maintain Product Inspection Process and Product Release Process, including Imported Finished Goods, Over-Labeled Products, and Returned Products

c)Implement and track Quality Hold(Global & local) in 3PL

d)Drive improvement for 3PL Quality Management System, implement and maintain Quality Agreements

e) Drive and execute rework activities

f) Initiate and track internal complaints resulting from labeling non-compliance

g) Perform first article inspection (FAI) for product distributed Asia Pacific market

h) Communicate and ensure implementation of documents (Procedure, WI etc.) at 3PL

 

- Ensure compliance of post market activities as per the country’s regulatory requirements, including MDR, FCA. Resolve post-market product quality issues, including hospital enquiry in partnership with stakeholders