The Role

We are seeking a highly skilled Quality Assurance Sr. Specialist to join our team in Japan. In this role, you will be responsible for establishing, maintaining, and improving the Quality Management System (QMS) for DexCom Japan.

You will lead and execute various quality-related activities, including document control, training, change management, internal/external audits, process monitoring/measurement, data analysis, and process improvement.

Additionally, you will support manufacturing activities from a quality/regulatory perspective, ensure product quality through inspections, and communicate with retailers/dealers on product handling.

Requirements

• A minimum of 5 years of experience in Quality and QMS/QC activities in the medical device/IVD industry.
• Experience in QMS establishment, maintenance, and activities is required.
• Internal auditor and External auditor experience is preferred.
• Strong self-leadership, logical thinking, and problem-solving skills.
• Native-level Japanese and business-level English communication skills.

What We Offer

• A front-row seat to life-changing CGM technology.
• A comprehensive benefits program.
• Growth opportunities on a global scale.
• Access to career development programs and qualified tuition reimbursement.
• An exciting, innovative organization committed to employees, customers, and communities.

Travel Required

5-15% travel may be required.