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:

• QMS Lifecycle Management: Manage the entire lifecycle of the Quality Management System (QMS), from initial development and implementation to ongoing maintenance and continuous improvement.
• Quality Culture Advocacy: Review quality activities through proactive communication with all departments to foster and embed a quality-centric culture across the organization.
• Internal Audit Leadership: Lead the end-to-end process of process monitoring and internal quality audits, including strategic planning, execution, and reporting of results.
• External Audit Management: Take full responsibility for managing and responding to external quality audits to ensure seamless certification.
• Quality Documentation Strategy: Oversee the preparation and alignment of quality documentation in accordance with new product launches and existing product enhancement strategies.
• System Operations: Operate and optimize Post-Market Surveillance (PMS), Risk Management, and Corrective and Preventive Action (CAPA) systems.
• Regulatory Compliance Monitoring: Continuously monitor changes in domestic and international regulatory environments and integrate the latest requirements into internal systems.

Qualifications

• Education: Bachelor’s degree or higher in Engineering, Quality Assurance, or a related field.
• Experience: Minimum of 5 years of experience in quality assurance (QA) within the medical device industry.
• Technical Expertise: Hands-on experience with quality audits such as KGMP, ISO 13485, and MDSAP.

Preferred

• SaMD Expertise: Experience with Software as a Medical Device (SaMD) quality standards.
• Startup Agility: Experience working in a fast-paced 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