(Seoul) Senior Quality Manager

"Conquering cancer through AI"Lunit, a portmanteau of ‘Learning unit,' is a medical AI software company devoted to providing AI-powered total cancer care.Our AI solutions help discover cancer and predict cancer treatment outcomes, achieving timely and individually-tailored cancer treatment.💭 About The TeamWe operate in one of the most conservative industries—healthcare—introducing the most innovative technologies, and persuading regulatory authorities to enable the greatest impact possible.At Lunit's Regulation Department, our Quality Management (QM) Team has the persistence and passion to tackle complex challenges head-on. Built upon that persistence and countless achievements, we continuously strive to run a forward-thinking, audit-ready quality system. We believe that truly listening to others and harmonizing different perspectives is what makes our team stronger. And above all—we are a team that's always ready to help one another.💭 About The PositionWe're looking for a bridge-builder in the world of Quality.At Lunit, our Cancer Screening Group (CSG) leads the mission of "Conquer cancer through AI". Now, as we continue to grow globally, we need someone who can make sure our quality stays as sharp as our vision.This isn't a typical Quality Manager role.You won't just be maintaining checklists or preparing for audits—you'll be connecting Lunit HQ in Seoul and Lunit International (formerly Volpara) in New Zealand, aligning two Quality Management Systems into a single beautifully synchronized orchestra.You'll read ISO 13485 like others read poetry, speak with engineers, developers, business managers in one day and still find the humor to say, "So... what did we learn from this CAPA?"It won't always be easy but we promise this: you'll experience a kind of achievement few people in our industry ever get to feel. You'll shape not just a system, but a new global standard for quality in AI-powered healthcare.If you find joy in order (but not in bureaucracy), if you believe "audit-ready" is a mindset, not a task, and if you're ready to lead with empathy, courage, and curiosity—then we'd love to meet you.👉 See a Day in the Life of Our Quality Management Team🚩 Roles & Responsibilities Lead Quality Management for Lunit HQ - Cancer Screening GroupAs a high level individual contributor, own, maintain, and continuously improve ISO 13485-compliant Quality Management System, MDSAP(5 countries), Korea GMP, MDR for CSG productsOversee 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 regulationsCollaborate with cross-functional teams (Regulatory Affairs, AI Engineering, Product Management, Clinical, and Legal) to ensure quality is embedded in all stages of product realizationImplement HQ CSG and cross-entity teams to maintain an "audit-ready" culture at all times 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 statusHarmonize key SOPs, policies, and quality manuals to minimize duplication and streamline global operationsIdentify critical process gaps and propose alignment roadmaps (align, merge or modify) for effective collaboration under dual-QMS operations Cross-Functional Collaboration Act as the functional bridge between Korea and New Zealand teams for Quality operationsPartner with RA, Engineering, Product, and Legal teams to ensure consistent interpretation and application of global QMS requirementsSupport integration of AI-specific Quality Management (AI QMS) and software lifecycle processes (IEC 62304, ISO 42001)Requirements🎯 Qualifications8+ years of professional experience in Medical Device Quality Management or Regulatory AffairsProficient in EnglishOverall understanding of the healthcare industry and passion for artificial intelligenceQMS operation and audit experienceDesign control & risk management process experienceStrong documentation and communication skillsCross-cultural communication skillsCollaborative leadership skillsGlobal mindset and professional maturityStrategic thinking and problem solvingChange management experience🏅 Preferred ExperiencesExpertise in Quality Data analysis and improvement📝 How to ApplyResume (free format)🏃‍♀️ Hiring ProcessDocument Screening → Intro call(Online, in English) → Competency-based Interview → Culture-fit Interview → OnboardingThe competency-based interview includes a written assessment followed by an in-person interviewAfter the final interview, we may proceed with reference checks if needed🤝 Work Conditions and EnvironmentWork type: Full TimeWork Location : Lunit HQ (5F, 374, Gangnam-daero, Gangnam-gu, Seoul)Salary: After Negotiation🎸 ETCIf you misrepresent your experience or education or provide false or fraudulent information in or with your application, it may be grounds for cancellation of the employmentLunit is committed in providing the preferential processing to those eligible for employment protection (national merits and people with disabilities) relevant to related laws and regulationsBenefits🌻 Benefits & PerksThe office is at a very convenient location, just a minute away from Gangnam Station Exit 3Meal Allowance is provided (up to 12,000 KRW per meal) when working at the officeUp to 300,000 KRW is covered upon joining to decorate your personal workspaceLatest computer models, such as Macs and 4K monitors are provided and can be renewed every three yearsSeminar registration fees and book purchases are coveredRegular in-house AI and medical seminars are heldKorean lessons are provided for Lunitians who do not speak Korean as their first languageIn-house English lessons (aka Luniversal) is provided for English developmentAccess to high-quality AI learning resources & deep learning DevOps systemUp to 1.2 million KRW worth of benefits points can be claimed annuallyHoliday Allowances are provided in the form of gifts or vouchers for Korean National holidays, Seollal and ChuseokCongratulatory and Condolence allowances, along with paid time off are providedAnnual medical checkups and employee accident insurance are providedExpenses for monthly employees gatherings are partially covered