QA 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 Regulatory Affairs Specialist collaborates with health authorities to establish and manage device registrations and regulatory strategies, ensuring regulatory approval and ongoing compliance for medical devices both domestically and internationally. This role is crucial in supporting essential regulatory processes for the launch of new products and the quality assurance of existing products.

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.
• Participate in and support 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.
• Actively participate in and support 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 1-3 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

Benefits:

• Flexible working conditions including work-from-home (2 days per week)
  • Remote work policies may change based on company circumstances or policies 
• 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

※ We collect submitted documents solely for conducting the recruitment process and notifying applicants of the results. Documents will be returned upon request. All submitted materials will be securely destroyed within 180 days of the job posting closure. Requests for document return can be made via the recruitment website or at hr@mediwhale.com.