QA&QC

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.

Capitalizing on the power of advanced data and AI technologies, our mission is to bridge the healthcare gap between doctors and patients, expediting the shift towards personalized and sustainable health. At this exciting juncture, we are looking for a QA&QC manager to make our revolutionary vision possible.

• Operate the domestic and international quality certifications (ISO 13485, KGMP, etc.)
• Handle the quality-related audits
• Create and manage the medical device quality documents (procedures, guidelines, etc.)
• Improve and operate the internal quality processes
• Conduct the domestic and international reporting tasks (including supply reporting)

Qualifications:

• A bachelor’s degree or higher
• Background in medical devices or engineering
• 3+ years of experience
• Quality experience with a related field (software, electronic medical devices)
• Experience with quality system audits (ISO 13485, KGMP, MDSAP, FDA) at least 2 times

Preferred:

• Experience with Risk Management and PSUR report
• Experience with medical device process validation and QC management
• Experience with setting up quality certification (eQMR)
• Utilization of statistical quality management
• Proactive, leadership-oriented, and positive mindset

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 – Job Interview with Presentation Assignment – HR 1st Interview – Tea time with CEO Selection
• 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
• Interviews: Each interview is expected to take approximately 30 to 50 minutes