19 Quality Assurance And Engineering jobs in Seoul.

Seoul

• Skills: Medical Device Development, Project Management, Cross-Functional Collaboration, Risk Management, Quality Assurance, Regulatory Compliance, Stakeholder Communication, Resource Allocation, Strategic Oversight, Process Improvement
• Experience: Minimum of 5 years in the medical device industry, with at least 2 years of experience managing medical device development projects
• Type: Full Time
• Salary: After Negotiation

Seoul

• Skills: pharmaceutical manufacturing, biologics manufacturing, Continuous Process Verification, supplier relationship management, CDMO, CLO, technical expertise, process control strategy, business performance reviews, cGXP regulations
• Experience: Deep experience in integrating related disciplinary knowledge with a strong technical background in pharmaceutical/biologics manufacturing.
• Type: Full-time

Seoul

• Skills: regulatory affairs, compliance, pharmacovigilance, NDA, GMP, stakeholders, team collaboration, product registration, regulatory submissions, analytical skills
• Experience: 5+ years
• Type: Full-time

Seoul

• Skills: Quality Management System, Medical Device, In-vitro Diagnostics, KGMP, ISO 13485, MDSAP, EU MDR/IVDR, UKCA, Regulatory Compliance, AI in Healthcare
• 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.
• Type: Contract
• Salary: Negotiable after interview

Incheon

• Skills: manufacturing sciences, technology transfer, process validation, product strategy, life cycle management, technical support, quality deviations, health authorities, external site, drug substance
• 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

Seoul

• Skills: 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
• Experience: 3년 이상
• Type: 정규직
• Salary: 면접 후 결정

Seoul

• Skills: quality oversight, clinical trials, risk management, compliance, data integrity, Quality Management Systems, inspection readiness, protocol development, regulatory submissions, stakeholder communication
• Experience: Minimum 5 years in pharmaceutical industry with 3 years or more in Quality Management.
• Type: Full time

Seoul

• Skills: quality compliance, supply chain, quality management, regulatory compliance, Good Distribution Practices, GMP, ISO 9001, analysis, collaboration, customer focused
• Experience: At least 7+ years of experience in regulated industry, preferably in Quality Control, Quality Assurance, or Supply Chain.
• Type: Regular

Seoul

• Skills: Quality Management, Regulatory Compliance, QMS Management, CAPA, Auditing, IFUs, Product Release, Medical Device Regulations, Korean Medical Device Act, Training
• Experience: >3 years of relevant RAQA experiences in the medical device industry.
• Type: Full-time

Seoul

• Skills: Regulatory Affairs, Medical Device, Regulatory Environment, Compliance, Applications, Certification, Process Improvement, Stakeholder Communication, Requirements, Submission
• Experience: Minimum 2 years of progressive RA experience in Medical Device Industry
• Type: Fixed Term (1 year)

Seoul

• Skills: design, electromechanical, robotics, medical products, mechanical components, failure analysis, design verification, manufacturing, risk assessments, regulatory compliance
• Experience: Minimum 8 years of experience designing and manufacturing electromechanical products

Seoul

• Skills: pharmacovigilance, PV system performance, regulatory inspections, adverse events, safety reports, Compliance, metrics, Quality Management System, literature review, audits
• Experience: A minimum of 3 years of experience within pharmacovigilance or a related field
• Type: Full-time

Seoul

• Skills: Regulatory, Medical Devices, Global Regulatory Intelligence, EU MDR, clinical evaluation, Product claims, Regulatory submissions, EU Notified Body, Advertising and Promotion, Regulatory Trends
• Experience: 10+ years
• Type: Full-time

Seoul

• Skills: Regulatory Affairs, Korean Health Authority, New Drug Application, Drug Master File, pharmaceutical regulations, registration procedures, regulatory compliance, submissions, clinical trials, medical devices
• Type: full_time
• Salary: {'min': None, 'max': None, 'period': '', 'currency': ''}

Seoul

• Skills: Regulatory Affairs, drug registration, marketing approval, K-NDA, K-IND, Local Product Documents, external regulatory environment, regulatory strategies, pharmaceutical industry, project management
• Type: full_time
• Salary: {'min': None, 'max': None, 'period': '', 'currency': ''}