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Lunit

AI-powered cancer detection and treatment

Senior Quality Management Specialist

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeSeoul, South KoreaNo salary listed

About the Job

Requirements

  • At least 7 years of quality management experience at a medical device manufacturer.
  • Experience writing and managing logical, systematic QMS documentation.
  • Experience responding to external quality audits, including certification-body, regulatory-authority, or partner audits.
  • Experience conducting internal audits.
  • Strong understanding of relevant standards, including ISO 13485, ISO 14971, and IEC 62304.
  • Ability to communicate in English, both in writing and verbally.
  • Ability to maintain consistency and accuracy in repetitive work.
  • Carefully check details and take responsibility for completing work.
  • Understanding of the medical industry and strong interest in diagnostic medicine and artificial intelligence.
  • Candidates must reside in Korea and have Korean proficiency appropriate for working in a Korean business.

Responsibilities

  • Maintain quality management systems for medical-device and in-vitro diagnostic medical-device software.
  • Write and maintain QMS documents, including procedures and records.
  • Monitor domestic and international requirements, conduct gap analyses, and incorporate requirements such as the EU AI Act into the QMS.
  • Collect and analyze post-market surveillance data and carry out improvement activities.
  • Operate and improve QMS processes, including corrective and preventive action, change control, and supplier management.
  • Plan and conduct internal audits.
  • Respond to external audits and inspections and manage follow-up, including corrective actions for nonconformities.
  • Handle certification and regulatory audits, including DGMP, ISO 13485, MDSAP, MDR, UKCA, and IVDR.
  • Respond to FDA inspections and partner audits.

Desired Qualifications

  • Proficiency using office and artificial intelligence tools.
  • Completion of ISO 13485 internal auditor or lead auditor training.
  • A degree major in biomedical engineering, industrial engineering, or another field related to medical devices or quality.
  • Proficiency in cross-departmental collaboration and multi-stakeholder communication.

About the Company

Lunit

AI-powered cancer detection and treatment

Lunit develops AI-powered software that helps hospitals detect cancer earlier and predict treatment responses by integrating into existing clinical workflows. Its AI analyzes medical images and related data to identify signs of early-stage cancer and forecast how well a treatment will work. Unlike some competitors, it has real-world deployments, such as nationwide use at Inje University Paik Hospital, and a global network of research partners, with a focus on integrating AI into current healthcare systems. Its goal is to improve cancer survival by enabling earlier detection and more personalized treatment planning.

Company size
201-500
Company stage
IPO
Headquarters
Seoul, South Korea
Founded
2013

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