Regional Quality Assurance Lead, Korea

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🔥 0 minutes ago

🇰🇷 South Korea – Remote

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

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Agilent Technologies

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1999

🍽️ Food & Beverage

🏥 Healthcare

💼 Consulting

💰 $500M Post-IPO Debt on 2019-09

Food & Beverage • Healthcare • Consulting

Agilent Technologies is a global leader in the field of analytical and laboratory instruments. The company offers a diverse range of products and solutions, including gas and liquid chromatography, mass spectrometry, lab supplies, and software and informatics. Agilent serves various industries, such as biopharma, food and beverage testing, clinical diagnostics, and environmental testing. Additionally, Agilent provides comprehensive services for lab management, maintenance, and instrument repair. They focus heavily on advancing science through sustainable solutions and supporting genomics, pathology, and cancer research with advanced technologies.

📋 Description

• Serve as the registered IVD Medical Device Quality Manager (품질책임자) for Agilent Korea • Manage and strengthen Agilent Korea's IVD Import License Model against MFDS regulations • Oversee outsourced warehouse operations, contractual agreements, testing review, product quality inspection, product release approval, audit readiness, deviation/CAPA management, and post-market activities • Maintain Korea QMS documentation and records, including procedures, change records, facility and equipment records, complaints, deviations, CAPAs, training, testing, inspection, and product release records • Perform and host MFDS, warehouse, and KGMP audits and inspections • Train Korea personnel on commercial quality requirements, procedures, and responsibilities • Prepare Medical Devices reports, including Import Annual Reports and Pre-Import Reports • Establish QMS processes and tools for consistent commercial quality execution 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 issue management and escalation • Support regional audits, inspections, and internal reviews • Partner with regulatory and regional teams to establish communication channels and communities of practice • Enable consistent quality execution across APAC through processes and training programs • Support risk-based compliance oversight and track APAC commercial quality issues, trends, and risks • Report to the International Quality Lead

🎯 Requirements

• Bachelor's degree (BS or BSc) in Engineering, Science, Life Science, Medical, Clinical Laboratory Science, or another relevant technical discipline, or directly equivalent experience in Quality Assurance • Must meet applicable statutory qualification requirements to serve as the registered Quality Manager (품질책임자) for IVD medical devices in South Korea; eligibility verified before appointment • Minimum 8 years’ experience in Quality Assurance, Regulatory Affairs, and Commercial Quality • Substantial hands-on experience in medical device or IVD Quality Assurance and import quality operations • Experience in regulated product environments, such as Medical Devices, IVDs, BioPharma, or related Life Science industries • Experience conducting and hosting audits and inspections • Strong knowledge of Korean medical device and IVD requirements, KGMP, US FDA CFRs, EU IVDR, MDSAP, ISO 13485, ISO 14971, and ISO 9001 • Professional proficiency in Korean and English, including reading, interpreting, and preparing regulatory and quality documentation • Understanding of international and APAC country-specific compliance considerations, including South Korea, Japan, Australia/New Zealand, Singapore, Malaysia, and Thailand • Experience working cross-functionally with Marketing, Sales, Commercial Compliance, Legal Compliance, Field Service, Regulatory, and Quality teams • Ability to manage risks, ensure consistency across regional organizations, and escalate issues promptly • Ability to initiate process improvement independently and align actions with International Quality • Ability to engage, influence, and negotiate with stakeholders in a matrixed environment • Ability to lead and manage processes, projects, and programs within APAC • Ability to multitask and prioritize competing tasks • Advanced MS Office skills: Outlook, Word, Excel, and PowerPoint • Basic AI knowledge for custom reports/dashboards, visualizations, metrics, and data presentation

🏖️ Benefits

• Option to work remotely • Annual mandatory 8-hour training per MFDS requirement • Equal opportunity employer

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