Location:
Tokyo or Nagoya (Hybrid / On‑site)
Employment Type:
Full-time
Industry:
Medical Devices / SaMD / BioTech / AI Diagnostics
Function:
Quality Assurance, QMS Leadership, Compliance
About the Company:
A rapidly growing AI×Biotechnology startup is developing next‑generation diagnostics by combining advanced machine-learning technology with novel biomarker science.
The company aims to create a future where people can live healthier, longer lives through early detection of serious diseases, including cancer.
Their flagship diagnostic product provides simple, non‑invasive, highly accurate cancer risk screening using urine samples, and has gained significant attention in the healthcare industry.
As the development of AI‑driven medical devices accelerates, the organization is now strengthening its Quality Management System (QMS) to meet the rigorous standards required for SaMD and next‑generation diagnostic technologies.
Role Overview:
The company is seeking an experienced Quality Assurance Manager / Senior Specialist to lead domestic quality operations and serve as the Domestic Quality Management Supervisor under Japanese regulations.
This position plays a critical role in establishing, operating, and enhancing the QMS while working closely with R&D, regulatory teams, and executive leadership.
Key ResponsibilitiesLead the construction, implementation, and operation of the Quality Management System (QMS)
Manage internal and external audits to ensure compliance with medical device regulations
Create, maintain, and control SOPs and quality documentation
Plan and oversee training programs, competency development, and organizational education
Drive change management, risk management, monitoring, evaluation, and quality KPIs
Support engineering teams in meeting quality requirements for medical device and SaMD product development
Collaborate with leadership and cross‑functional teams to ensure product reliability and regulatory alignment
Required Qualifications:
Bachelor's degree in science, engineering, medicine, or a related field
3+ years of QMS operational experience in the medical device industry (preferably SaMD)
Practical operational experience with:
ISO 13485, ISO 14971, IEC Minimum 3 years)
Nice to Have:
Ability to thrive in a fast‑paced, evolving environment
Proactive leadership with strong project ownership
Collaborative mindset with respect for diversity and cross‑functional teamwork
What the Company Offers
Opportunity to take a leading role in AI‑driven medical device innovation
Chance to shape and elevate the company's quality strategy and QMS foundation
Clear path toward QA leadership and global standard alignment
Competitive salary with strong benefits
Flexible working hours, full weekly schedule with weekends off, and no transfers
Comprehensive benefits, training programs, and a supportive culture
How to Apply
If you have strong experience in medical device quality systems and are passionate about shaping the future of healthcare through technology, we encourage you to apply.
Please submit your CV or reach out for more information.Show more Show less
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