Regional Quality Assurance Lead (Korea)
Core
Serve as the registered IVD Medical Device Quality Manager for Agilent Korea, managing governance, quality systems, and commercial quality activities for outsourced warehouse and testing operations while providing regional oversight for the APAC channel partners.
Role type
Senior IC Quality Manager (Medical Devices/IVD)
Builds
Quality management systems and compliance processes for IVD medical device import and distribution in Korea and APAC
Domain
Medical Devices / In-Vitro Diagnostics (IVD) / Regulatory Compliance
Deliverable
dashboards & analysis
Required skills
Korean (professional proficiency), English (professional proficiency), IVD Quality Management, KGMP regulations, MFDS regulations, audit management, CAPA management, risk management, stakeholder negotiation, cross-functional leadership
Preferred skills
MBA, Quality Management certification, experience as registered Quality Manager in Korea, experience with US FDA CFRs, EU IVDR, MDSAP, ISO 13485, ISO 14971, ISO 9001, AI tools for reporting
Technologies
MS Office (Outlook, Word, Excel, PowerPoint), analytical tools for dashboards
Responsibilities
Manage governance and quality systems against MFDS regulations for outsourced warehouse and testing; oversee outsourced warehouse and testing activities including product release approval; maintain QMS documentation and records; perform and host audits including MFDS and KGMP audits; provide training to personnel on commercial quality requirements; prepare Medical Devices reports including Import Annual Reports and Pre-Import Reports; establish QMS processes for APAC channel partners; track APAC regional commercial quality issues and risks
Seniority
Senior, hands-on IC