(Seoul) Senior Quality Manager - 인크루트 채용

🚩 Roles & Responsibilities 1. Lead Quality Management for Lunit HQ – Cancer Screening Group As a high level individual contributor, own, maintain, and continuously improve ISO 13485-compliant Quality Management System, MDSAP(5 countries), Korea GMP, MDR for CSG products. Oversee the full QMS lifecycle — from design control, document control, risk management, CAPA, internal audit, and training — ensuring compliance with MDR, MDSAP, KGMP, and other applicable regulations. Collaborate with cross-functional teams (Regulatory Affairs, AI Engineering, Product Management, Clinical, and Legal) to ensure quality is embedded in all stages of product realization. Implement HQ CSG and cross-entity teams to maintain an “audit-ready” culture at all times. 2. Lead Global Quality Integration between Lunit HQ and Lunit International (Volpara) Drive the alignment of Quality Management Systems between Lunit HQ (CSG) and Lunit International (formerly Volpara), maintaining each entity’s independent legal manufacturer status. Harmonize key SOPs, policies, and quality manuals to minimize duplication and streamline global operations. Identify critical process gaps and propose alignment roadmaps (align, merge or modify) for effective collaboration under dual-QMS operations. 3. Cross-Functional Collaboration Act as the functional bridge between Korea and New Zealand teams for Quality operations. Partner with RA, Engineering, Product, and Legal teams to ensure consistent interpretation and application of global QMS requirements. Support integration of AI-specific Quality Management (AI QMS) and software lifecycle processes (IEC 62304, ISO 42001). Requirements 🎯 Qualifications 8+ years of professional experience in Medical Device Quality Management or Regulatory Affairs Proficient in English Overall understanding of the healthcare industry and passion for artificial intelligence QMS operation and audit experience Design control & risk management process experience Strong documentation and communication skills Cross-cultural communication skills Collaborative leadership skills Global mindset and professional maturity Strategic thinking and problem solving Change management experience