QA Specialist

Daily Duties

1. Quality Assurance for Products:
   • Ensure the efficacy, quality, and safety of medical devices manufactured in Japan and overseas.
   • Handle quality-related tasks for new product introductions and product modifications, including change management.
   • Conduct discontinuation procedures for items, manufacturers, or part numbers.
2. Quality-Related Tasks:
   • Coordinate test samples and oversee validation reviews.
   • Update packaging and sterilization agreements, arrange sterilization tests, and review catalogs and guides.
   • Maintain regulatory data in the QAD system.
   • Collaborate with overseas stakeholders for quality-related activities.
3. Non-Conformity and Complaint Handling:
   • Address non-conformities and product complaints to prevent the spread of defects.
   • Implement measures to improve product quality.
4. Regulatory Compliance:
   • Manage documentation required by the Pharmaceuticals and Medical Devices Act and ISO13485.
   • Ensure seamless business operations and compliance.
5. Additional Tasks:
   • Respond to inquiries, process invoices, conduct audits, and handle ad hoc projects.

Required Skills & Experience:

• Expertise in quality management systems (ISO13485) and the Pharmaceuticals and Medical Devices Act.