QA

About us:

Mediwhale is a pioneering AI healthcare startup focusing on predicting cardiovascular, renal, and metabolic disease (CVRM) risks using retinal biomarkers. The eye is the only organ where blood vessels are directly visible without invasive procedures, which is our key to unlocking unprecedented insights into human health.

At Mediwhale, the QA Specialist oversees the quality management and assurance activities for medical devices, ensuring compliance with domestic and international regulatory standards while maintaining product quality. The role involves operating a quality management system based on international standards such as ISO 13485 and KGMP, and collaborating with various internal departments to achieve quality objectives.

Responsibilities:

• Quality Management System (QMS) Management: Develop, implement, maintain, and improve the QMS in compliance with domestic and international standards
• Internal and External Audit Management: Plan and conduct regular internal quality audits, and lead preparation and responses for external regulatory audits
• Regulatory Requirements Analysis: Monitor and analyze the latest requirements from regulatory bodies such as MFDS, FDA, and CE
• Preparation of Product Registration and Submission Documents: Prepare and review quality documents necessary for new product launches and regulatory approvals for existing products
• CAPA Management: Effectively manage corrective and preventive action processes to address nonconformities and apply systematic approaches to prevent recurrence
• PMS (Post-Market Surveillance) System Management: Establish and execute PMS plans
• Production and Process Validation Collaboration and Training: Work closely with the Product team to promote quality integration and provide training on process validation procedures
• Risk Management Process Operation: Design and implement risk management processes throughout the product lifecycle in accordance with ISO 14971, including risk assessment and control

Qualifications:

• Bachelor’s degree or higher in Engineering, Quality Management, or a related field
• Minimum of 5 years of experience in quality assurance within the medical device industry
• Strong understanding of medical device regulatory requirements (ISO 13485, KGMP, FDA, EU MDR), risk management, process validation, and PMS systems
• Experience with quality-related audit management is preferred

Preferred:

• Strong attention to detail and commitment to process improvement and regulatory compliance
• Excellent communication and problem-solving skills
• Ability to manage multiple tasks in a fast-paced environment

Benefits:

• Flexible working conditions including work-from-home (2 days per week) 
• Company-supported daily lunch and snacks
• Annual comprehensive health check-up
• Additional leaves including vaccine leave, birthday leave, and condolence leave, in addition to statutory annual leave
• Support for work-related books and job-related training

Application Process:

• Process: Document screening – 1st interview – 2nd interview – Final Acceptance
  • Tasks may be assigned according to the role, and the interview process may be subject to change.
• Application documents: Free format (including resume)
  • Please highlight your motivation for applying to Mediwhale, your interest in the position, and your strengths related to the job
  • Please submit one copy of your resume in both Korean and English.
• Interviews: Each interview is expected to take approximately 30 to 50 minutes