Last updated: 2025-05-22

16 Quality Assurance And Engineering jobs in Seoul.

Hiring now: Functional Leader In Manu @ Biogen, Sr Quality Management Spe @ Lunit, Regulatory Affairs Spec M @ Intuitive , Pv Operational Associate @ Abbvie, Mgr Regulatory Affairs Ap @ Johnson Jo, Quality Compliance Mgr @ Amgen, Sr Regulatory Affairs Spe @ Novo Nordi.Explore more at at kaamvaam.com

🔥 Skills

regulatory compliance (3) regulatory submissions (3) compliance (3) Process Improvement (3) medical devices (2) ISO 13485 (2) MDSAP (2) UKCA (2) regulatory affairs (2) medical device (2)

📍 Locations

Seoul (15) Incheon (1)
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Biogen

Functional Leader in Manufacturing Execution Seoul
Skills & Focus: pharmaceutical manufacturing, biologics manufacturing, Continuous Process Verification, supplier relationship management, CDMO, CLO, technical expertise, process control strategy, business performance reviews, cGXP regulations
About the Company: Biogen is a biotechnology company that discovers, develops, and delivers innovative therapies for people living with serious neurological and neurodegenerative…
Experience: Deep experience in integrating related disciplinary knowledge with a strong technical background in pharmaceutical/biologics manufacturing.
Type: Full-time

Lunit

Sr. Quality Management Specialist Seoul
Skills & Focus: quality management system, medical devices, software medical devices, ISO 13485, MDSAP, EU MDR, UKCA, internal audit, external audit, CAPA process
About the Company: Lunit, short for 'Learning Unit', is a medical AI company that develops and offers AI solutions contributing to cancer diagnosis and treatment.
Experience: 10 years or more in quality management system operation and management within medical device or in vitro diagnostic industries.
Salary: Negotiable after interview
Type: Full-time
Benefits: Various benefits including meal support, equipment allowances, participation in conferences and training, and health ch…

Intuitive Surgical

Regulatory Affairs Specialist – Mandarin Speaking Seoul
Skills & Focus: regulatory affairs, NMPA, medical device, product registration, regulatory compliance, project management, team collaboration, regulatory submissions, clinical strategy, product lifecycle
About the Company: A pioneer and market leader in robotic-assisted surgery, committed to advancing minimally invasive care through innovative technology.
Experience: Minimum 3 years RA experience, 1 year NMPA requirements
Type: Full-time
Benefits: Comprehensive healthcare, professional development, family support, and equity opportunities

Lunit

Jr. Quality Management Specialist Seoul
Skills & Focus: Quality Management System, Medical Device, In-vitro Diagnostics, KGMP, ISO 13485, MDSAP, EU MDR/IVDR, UKCA, Regulatory Compliance, AI in Healthcare
About the Company: Lunit is a medical AI company that develops and provides AI solutions for cancer diagnosis and treatment.
Experience: At least 1 year of experience in quality management system operation and management at a medical device or in-vitro diagnostic medical device manufacturer.
Salary: Negotiable after interview
Type: Contract
Benefits: Benefits include meal allowances, unlimited snacks, desk decoration support, attendance support for conferences, traini…

Intuitive Surgical

Head of Clinical Research Engineering Seoul
Skills & Focus: clinical research, engineering leadership, medical devices, robotic systems, clinical studies, product development, regulatory compliance, patient safety, prototype evaluation, team management
About the Company: At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, w…
Experience: 10+ years in medical device development, 5+ years in leadership
Type: Full-time
SCM Specialist (Fixed Term) Seoul
Skills & Focus: SCM, warehouse management, 3PL, inventory reconciliation, KMDIA, data validation, medical device, regulations, cycle counting, customs audit
About the Company: At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, w…
Experience: Minimum Bachelor’s degree or equivalent Work experience in warehouse management, demand planning or SCM in Medical device industry is preferred

Abbvie

PV Operational Associate Seoul
Skills & Focus: pharmacovigilance, PV system performance, regulatory inspections, adverse events, safety reports, Compliance, metrics, Quality Management System, literature review, audits
About the Company: AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tom…
Experience: A minimum of 3 years of experience within pharmacovigilance or a related field
Type: Full-time

Johnson & Johnson

Manager, Regulatory Affairs APAC Seoul
Skills & Focus: regulatory, health authority, registration, life cycle management, medical, pharmaceutical, compliance, submission, strategy, interactions
About the Company: A leading healthcare company committed to innovative medicine and MedTech solutions.

Lunit

Program Manager Seoul
Skills & Focus: Medical Device Development, Project Management, Cross-Functional Collaboration, Risk Management, Quality Assurance, Regulatory Compliance, Stakeholder Communication, Resource Allocation, Strategic Oversight, Process Improvement
About the Company: Lunit, derived from the term 'Learning Unit', is a medical AI company that develops and provides AI solutions for cancer diagnosis and treatment. The goal is t…
Experience: Minimum of 5 years in the medical device industry, with at least 2 years of experience managing medical device development projects
Salary: After Negotiation
Type: Full Time
Benefits: Meal Allowance, Workspace Decoration Budget, Latest Computer Equipment, Seminar and Book Support, Health Check-ups, Pai…

Johnson & Johnson

[MedTech] Associate Commercial Quality Manager, HSD(Handling, storage & distrib… Seoul
Skills & Focus: quality compliance, supply chain, quality management, regulatory compliance, Good Distribution Practices, GMP, ISO 9001, analysis, collaboration, customer focused
About the Company: Johnson & Johnson is a leading global healthcare company dedicated to innovation in healthcare solutions across various segments.
Experience: At least 7+ years of experience in regulated industry, preferably in Quality Control, Quality Assurance, or Supply Chain.
Type: Regular

Intuitive Surgical

Project Coordinator Seoul
Skills & Focus: Project Management, Product Development, Cross-functional Collaboration, Risk Management, Design Control, Regulatory Submissions, Milestone Tracking, Quality Systems, Medical Devices, Process Improvement
About the Company: At Intuitive, we are committed to minimally invasive care through innovative robotic-assisted surgery technology. We foster an inclusive and diverse team dedic…

Lunit

Technical Engineering Manager Seoul
Skills & Focus: Technical Engineering Manager, Software as a Medical Device, Requirements Specification, Stakeholder Collaboration, Customer Feedback Analysis, Product Development, Engineering Management, Software Requirements, Medical Device Guidelines, AI technology
About the Company: Lunit은 'Learning Unit'을 줄여 만든 이름으로, 암 진단 및 치료에 기여하는 인공지능 솔루션을 개발하고 제공하는 의료 AI 기업입니다. 루닛은 인공지능 기술을 통해 더 정확한 암 진단과 치료 효과 예측이 가능해지고, 환자를 위한 신속한 맞춤형 치료가 가능해지는 시대를 …
Experience: 3년 이상
Salary: 면접 후 결정
Type: 정규직
Benefits: 오피스 근무 시 12,000원의 식비 지원 및 무제한 간식 제공, 최신 사양의 컴퓨터 장비 지원, 학회 참석 및 직무 교육 지원 등.

Amgen

Quality Compliance Manager Seoul
Skills & Focus: quality oversight, clinical trials, risk management, compliance, data integrity, Quality Management Systems, inspection readiness, protocol development, regulatory submissions, stakeholder communication
About the Company: Amgen is a leading biotechnology company, focused on improving lives through innovative medicines.
Experience: Minimum 5 years in pharmaceutical industry with 3 years or more in Quality Management.
Type: Full time

Novo Nordisk

Senior Regulatory Affairs Specialist Seoul
Skills & Focus: regulatory affairs, compliance, pharmacovigilance, NDA, GMP, stakeholders, team collaboration, product registration, regulatory submissions, analytical skills
About the Company: Novo Nordisk is a global healthcare company specializing in diabetes care and other serious chronic conditions.
Experience: 5+ years
Type: Full-time

Johnson & Johnson

[MedTech] Regulatory Affairs Specialist - SPECIAL PROJECTS Seoul
Skills & Focus: Regulatory Affairs, Medical Device, Regulatory Environment, Compliance, Applications, Certification, Process Improvement, Stakeholder Communication, Requirements, Submission
About the Company: Johnson & Johnson is a multinational corporation that develops medical devices, pharmaceuticals, and consumer packaged goods.
Experience: Minimum 2 years of progressive RA experience in Medical Device Industry
Type: Fixed Term (1 year)
MSAT External Site Lead Incheon
Skills & Focus: manufacturing sciences, technology transfer, process validation, product strategy, life cycle management, technical support, quality deviations, health authorities, external site, drug substance
About the Company: At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented,…
Experience: Proven track record in large molecules in at least three of these areas: process development, new product introduction, technology transfer, process validation and/or ongoing production support.
Type: Fully Onsite