QA Specialist III

1. Assess the impact of global, APAC, local procedural, and regulatory changes, and support implementation of required actions including document updates, training, and follow-up activities Support Management Review, Internal Audits, document control, and quality record management activities to ensure an effective and inspection-ready Quality System Support KGMP certification and renewal activities, as well as inspections and audits conducted by MFDS and other regulatory authorities Identify quality and regulatory risks associated with product launches, supply chain changes, new business initiatives, and business transfer projects, and collaborate with stakeholders to implement appropriate mitigation actions Support compliance with quality requirements throughout the distribution lifecycle of imported medical devices, including receipt, inspection, storage, release, returns, and disposition Participate in quality management activities for 3PL warehouses, suppliers, distributors, and outsourced service providers Establish and support appropriate quality processes for various supplier relationships (e.g., SFMD, TPI, 3PL), including quality agreements, change control, supplier qualification, KPI reviews, SCARs, and on-site audits Support quality activities related to product launches, inventory management, warehousing, and commercial operations Support quality activities related to installation, servicing, field service operations, and service center management Perform validation and qualification activities required by the Quality System, including warehouse facility qualification and software validation Support testing, certification, and documentation activities related to used medical devices Collaborate with Operations, Technical Service, Supply Chain, Regulatory Affairs, and other stakeholders to manage quality risks associated with product handling and service processes Manage or support post-market quality processes including complaint handling, vigilance reporting, foreign matter reporting, UDI management, field actions, and product recalls Participate in continuous improvement, digitalization, and process automation initiatives that enhance compliance, operational effectiveness, and quality culture Bachelor's degree in Life Sciences, Engineering, Pharmacy, Medical Technology, Quality, Regulatory Affairs, or related discipline Minimum 7 years of experience in quality system management within a regulated industry Working knowledge of ISO 13485, medical device quality system requirements, and Korean medical device regulations Ability to independently manage assigned processes, coordinate cross-functional actions, and escalate quality or compliance risks appropriately Strong written and verbal communication skills in Korean and English Strong documentation, analytical thinking, prioritization, and stakeholder management skills Lead Auditor, Internal Auditor, CAPA Mentor, or equivalent quality certifications Experience with eQMS systems, data analytics, Power BI, automation, or AI-based productivity tools Internal Auditor, Lead Auditor, CAPA, Six Sigma, Lean, Quality Engineer, Regulatory Affairs, or equivalent certification preferred Project management experience with the ability to lead or coordinate cross-functional initiatives under ambiguity