Quality Assurance Specialist

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:

• Manage the entire process of Quality Management System (QMS) from development to implementation, maintenance, and improvement.
• Review quality activities and promote quality culture throughout the organization through active communication with each department.
• Lead the entire process from planning and implementing process monitoring and internal quality audits to sharing results.
• Take responsibility for overall preparation to external quality audits.
• Manage the preparation of quality documentation in alignment with new product launch and existing product improvement strategies.
• Operate PMS, risk management, and CAPA systems.
• Continuously monitor changes in domestic and international regulatory environments to incorporate the latest requirements into company systems.

Qualifications:

• Bachelor’s degree or higher in engineering, quality assurance, or related field
• Minimum 5 years of experience in medical device quality assurance
• Experience with quality audits (KGMP, ISO 13485, MDSAP, etc.)

Preferred:

• Experience with Software as Medical Device (SaMD)
• Experience working in a startup environment

Competencies:

• Achieving goals through persistent communication with diverse team members
• Compliance and ethical awareness
• Strategic thinking based on business mindset
• Document writing and comprehension skills in both Korean and English
• Analyzing and problem-solving skills
• To build evidence-based logic through scientific thinking
• Adjusting priorities and effectively managing multiple tasks in a rapidly changing environment
• Ability to thoroughly review and document details

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