(Seoul) Senior Quality Manager at Lunit

Seoul, , South Korea -

Full Time

Start Date

Immediate

Expiry Date

18 Feb, 26

Salary

0.0

Posted On

20 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management, Regulatory Affairs, ISO 13485, MDSAP, Korea GMP, MDR, Cross-Functional Collaboration, Documentation Skills, Communication Skills, Strategic Thinking, Problem Solving, Change Management, Quality Data Analysis, Risk Management, Audit Experience, Collaborative Leadership

Industry

Software Development

Description

"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 Team We 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 Position We’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 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). 🎯 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 🏅 Preferred Experiences Expertise in Quality Data analysis and improvement 📝 How to Apply Resume (free format) 🏃‍♀️ Hiring Process Document Screening → Intro call(Online, in English) → Competency-based Interview → Culture-fit Interview → Onboarding The competency-based interview includes a written assessment followed by an in-person interview. After the final interview, we may proceed with reference checks if needed. 🤝 Work Conditions and Environment Work type: Full Time Work Location : Lunit HQ (5F, 374, Gangnam-daero, Gangnam-gu, Seoul) Salary: After Negotiation 🎸 ETC If 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 employment. Lunit is committed in providing the preferential processing to those eligible for employment protection (national merits and people with disabilities) relevant to related laws and regulations. 🌻 Benefits & Perks The office is at a very convenient location, just a minute away from Gangnam Station Exit 3. Meal Allowance is provided (up to 12,000 KRW per meal) when working at the office. Up to 300,000 KRW is covered upon joining to decorate your personal workspace. Latest computer models, such as Macs and 4K monitors are provided and can be renewed every three years. Seminar registration fees and book purchases are covered. Regular in-house AI and medical seminars are held. Korean lessons are provided for Lunitians who do not speak Korean as their first language. In-house English lessons (aka Luniversal) is provided for English development. Access to high-quality AI learning resources & deep learning DevOps system. Up to 1.2 million KRW worth of benefits points can be claimed annually. Holiday Allowances are provided in the form of gifts or vouchers for Korean National holidays, Seollal and Chuseok. Congratulatory and Condolence allowances, along with paid time off are provided. Annual medical checkups and employee accident insurance are provided. Expenses for monthly employees gatherings are partially covered.

Responsibilities

Lead the Quality Management for Lunit HQ's Cancer Screening Group, ensuring compliance with various quality standards. Drive the alignment of Quality Management Systems between Lunit HQ and Lunit International, harmonizing key SOPs and policies.