17 Quality Engineering jobs in Seoul.

Hiring now: Functional Leader In Manu @ Biogen, Sr Quality Management Spe @ Lunit, Scientist I @ Hb Fuller, Pharmacovigilance Lead Pv @ Novo Nordi, Scm Spec Fixed Term @ Intuitive , Cra Ii Sr Cra I Fsp Korea @ Syneos Hea, Medtech Associate Commerc @ Johnson Jo, Quality Compliance Mgr @ Amgen.Explore more at jobswithgpt.com.

🔥 Skills

regulatory compliance (5) compliance (4) audit readiness (3) ISO 13485 (2) Regulatory Compliance (2) risk management (2) stakeholders (2) Quality Assurance (2) communication skills (2) collaboration (2)

📍 Locations

Seoul (15) Incheon (2)

Biogen

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

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…

H.B. Fuller

Skills & Focus: Safety Data Sheets, Regulatory Compliance, GHS Requirements, Customer Support, Global R&D, Regulatory Trends, Collaborative Culture, Product Managers, Cross-Functional Teams, Sustainability Inquiries
About the Company: As the largest pureplay adhesives company in the world, H.B. Fuller’s innovative, functional coatings, adhesives and sealants enhance the quality, safety and p…

Novo Nordisk

Skills & Focus: Pharmacovigilance, safety information, compliance, quality, risk management, training, audits, inspections, Standard Operating Procedures, stakeholders
About the Company: Novo Nordisk is a global healthcare company with more than 100 years of innovation and leadership in diabetes care. The company employs over 63,000 people in 8…
Experience: At least 5 years of relevant experience in Pharmacovigilance is preferred.
Type: Permanent

Lunit

Skills & Focus: Regulatory Affairs, Medical Device, Cancer Diagnosis, Business Growth, FDA Compliance, European Market Regulations, Communication Skills, AI Technology, Medical Regulations, Clinical Regulatory Experience
About the Company: Lunit is a healthcare AI company that develops and provides AI solutions that contribute to cancer diagnosis and treatment.
Experience: 15 years or more in the field of medical device Regulatory Affairs
Salary: Negotiable after the interview
Type: Full-time
Benefits: Lunch and dinner meal allowance, unlimited snacks, support for desk decoration costs, high-spec computer equipment, tra…
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…
Skills & Focus: Software as a Medical Device (SaMD), SRS (Software Requirements Specification), stakeholder, VOC analysis, technical product manager, software development, communication skills, collaboration, AI knowledge, DICOM standard
About the Company: Lunit, short for 'Learning Unit', is a medical AI company developing and providing AI solutions that contribute to cancer diagnosis and treatment. Lunit aims t…
Experience: 3+ years of experience as an engineering manager (especially technical product manager) or equivalent experience
Salary: Negotiable after interview
Type: Full-time
Benefits: Office located 1 minute walking distance from Gangnam Station, 12,000 KRW food support for lunch/dinner and unlimited s…

Novo Nordisk

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

Intuitive Surgical

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

Syneos Health

Skills & Focus: site qualification, site management, monitoring, GCP, regulatory compliance, clinical data, patient safety, investigational product, documentation, audit readiness
About the Company: Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medic…
Experience: Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience

Johnson & Johnson

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

Syneos Health

Skills & Focus: site qualification, site monitoring, regulatory compliance, ICH-GCP, informed consent, data capture, audit readiness, clinical trial management, pharmacovigilance, remote monitoring
About the Company: Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medic…
Experience: Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
Type: Hybrid
Benefits: Total rewards program including career development and progression

Amgen

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

Syneos Health

Skills & Focus: remote site qualification, site initiation, monitoring calls, regulatory compliance, ICH-GCP, Good Clinical Practice, data capture, investigational product, audit readiness, communication skills
About the Company: Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.
Experience: Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience

Johnson & Johnson

Skills & Focus: Quality Management System, regulatory compliance, Warehouse, Supply Chain, Good Distribution Practices, Quality Assurance, ISO 9001, ISO 13485, sample management, compliance
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: At least 7+ years of experience in regulated industry, preferably in Quality Control, Quality Assurance, or Supply Chain.
Type: Regular
Benefits: Preference will be given to individuals subject to national veterans’ benefits and persons with disabilities.
Skills & Focus: Project Engineering, Supply Chain, Process Engineering, Manufacturing, Commissioning, Qualification, Technical support, Project management, Quality compliance, GMP/GXP
Experience: Minimum 5+ years of professional experience
Type: Fully Onsite
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