Regional Quality Assurance Lead, Korea

This is a fully remote position, open to applicants in South Korea.

📋 Description

• Act as the registered IVD Medical Device Quality Manager (품질책임자) for Agilent Korea.

• Manage and enhance Agilent Korea's IVD Import License Model in compliance with MFDS regulations.

• Supervise outsourced warehouse operations, contractual agreements, testing reviews, product quality inspections, product release approvals, audit readiness, deviation/CAPA management, and post-market activities.

• Maintain documentation and records for Korea QMS, including procedures, change records, facility and equipment records, complaints, deviations, CAPAs, training, testing, inspection, and product release records.

• Conduct and lead MFDS, warehouse, and KGMP audits and inspections.

• Educate Korea personnel on commercial quality requirements, procedures, and responsibilities.

• Compile Medical Devices reports, such as Import Annual Reports and Pre-Import Reports.

• Develop QMS processes and tools to ensure consistent execution of commercial quality across APAC.

• Negotiate quality agreements and contract quality elements with APAC operating companies and channel partners.

• Direct customer-reported quality signals and feedback to International Quality for effective issue management and escalation.

• Assist with regional audits, inspections, and internal reviews.

• Collaborate with regulatory and regional teams to establish communication channels and communities of practice.

• Facilitate consistent quality execution across APAC through established processes and training programs.

• Support risk-based compliance oversight and monitor APAC commercial quality issues, trends, and risks.

• Report directly to the International Quality Lead.

⛳️ Requirements

• Bachelor's degree (BS or BSc) in Engineering, Science, Life Science, Medical, Clinical Laboratory Science, or a related technical discipline, or equivalent experience in Quality Assurance.

• Must fulfill the statutory qualification requirements to serve as the registered Quality Manager (품질책임자) for IVD medical devices in South Korea; eligibility will be verified prior to appointment.

• At least 8 years of experience in Quality Assurance, Regulatory Affairs, and Commercial Quality.

• Significant hands-on experience in medical device or IVD Quality Assurance and import quality operations.

• Experience in regulated product environments, including Medical Devices, IVDs, BioPharma, or related Life Science sectors.

• Proven experience in conducting and hosting audits and inspections.

• Strong understanding of Korean medical device and IVD requirements, KGMP, US FDA CFRs, EU IVDR, MDSAP, ISO 13485, ISO 14971, and ISO 9001.

• Proficient in Korean and English, with the ability to read, interpret, and prepare regulatory and quality documentation.

• Familiarity with international and APAC country-specific compliance considerations, including South Korea, Japan, Australia/New Zealand, Singapore, Malaysia, and Thailand.

• Experience collaborating cross-functionally with Marketing, Sales, Commercial Compliance, Legal Compliance, Field Service, Regulatory, and Quality teams.

• Capability to manage risks, ensure consistency across regional organizations, and promptly escalate issues as needed.

• Ability to independently initiate process improvements and align actions with International Quality standards.

• Skilled at engaging, influencing, and negotiating with stakeholders in a matrixed environment.

• Competent in leading and managing processes, projects, and programs within APAC.

• Ability to multitask and prioritize competing responsibilities effectively.

• Advanced proficiency in MS Office applications: Outlook, Word, Excel, and PowerPoint.

• Basic knowledge of AI for creating custom reports/dashboards, visualizations, metrics, and data presentation.

🏝️ Benefits

• Option for remote work.

• Annual mandatory 8-hour training as required by MFDS.

• Equal opportunity employer.