Join a global leader in health technology as a Senior Quality Assurance Specialist, taking ownership of the Quality Management System (QMS) to ensure full compliance with Japanese medical device regulations. In this key role, you will safeguard product safety, manage quality processes, and drive improvements that directly impact patients across Japan. This is an opportunity to become the primary QA expert in a fast-growing international organisation committed to improving health outcomes.
Key Responsibilities
- Inspect new medical device products entering Japan to confirm safety and compliance.
- Manage non-conforming products and implement corrective actions.
- Ensure the QMS aligns with all Japanese medical device laws and standards.
- Lead internal audits and manage QMS documentation, records, and training activities.
- Identify system issues, propose improvements, and drive continuous enhancement.
- Collaborate with suppliers, distributors, and global manufacturing teams to maintain quality.
- Support the creation of Japanese labels and review promotional and marketing materials.
Required Skills and Qualifications
Experience:
- 3+ years of experience in medical device quality assurance.
- Strong knowledge of QMS maintenance, audits, and compliance activities.
- Experience communicating with Japanese health authorities and government agencies.
- Practical understanding of product safety, documentation, and regulatory workflows.
Soft Skills:
- Strong project leadership and cross-functional coordination abilities.
- Clear and analytical problem-solving skills.
- Ability to work independently while collaborating across teams.
Language Requirements:
- Japanese: Native level.
- English: Intermediate to Business level.
Preferred Skills & Qualifications
- Quality Control experience.
- Experience building a new QMS from the ground up.
- Experience leading product safety assessments and risk management.
- Ability to train and educate employees on quality processes.
About the Company
Our client is a U.S.-headquartered global leader in health technology, known for 25 years of innovation in devices that help individuals easily monitor glucose levels. Their products empower people with diabetes and other conditions to take control of their health. The company promotes a culture of quality, patient safety, and continuous improvement across all markets.
Why You'll Love Working Here
- Contribute directly to improving health outcomes for people across Japan.
- Serve as the key QA expert within a rapidly expanding global medical device company.
- Lead and enhance the Japan QMS, ensuring high standards of safety and compliance.
- Work in a dynamic, diverse, and mission-driven environment.
- Enjoy opportunities for professional growth and meaningful impact.
Don't Miss Out - Apply Now!
