Where you Come In
Ø You will lead and manage the following QMS-related activities
Document and record control process and training process with Dexcom Inc. Quality team.
QMS planning process in Dexcom Japan.
Change management of new or revised regulatory requirements from a QMS perspective with the Dexcom Japan Regulatory Affairs and Safety team.
Site management review process and commercial material review process.
Support customer-related processes with the Customer Service team and Technical Support team.
Outsource, supplier, and subcontractor management process with the Dexcom Inc. Quality team, including contract management and regulatory license management.
Internal and external audit process with the Dexcom Inc. Quality team.
Process monitoring and measurement, data analysis, process improvement, and CAPA.
Ø You will also lead and manage the following quality operation-related activities:
Manufacturing activities (both domestic and foreign sites) from a quality and regulatory perspective with the relevant team.
Establish, maintain, and improve domestic manufacturing and inspection activities from a QMS/QC perspective, including:
§ Incoming quality check process and product release decision process.
§ Nonconformance product handling process, including rework, concession, and ship hold.
§ Country-specific label, e-packaging insert, and IFU establishment process.
§ Infrastructure management and monitoring and/or measurement device management process, including periodical maintenance and calibration.
§ Work environment management.
§ Device Master Record creation.
§ DHR review.
Ø Product realization process and risk management process with the Dexcom Inc. Quality team.
Ø Communication with retailers and dealers to ensure product quality.
Ø Change management of medical devices from both product quality and quality operation perspectives with the Dexcom Japan Regulatory Affairs, Safety, and other relevant teams.
Ø Gather information related to product quality (including occurred and/or potential product malfunction and nonconformity) from the Japanese market in cooperation with the Dexcom Japan Safety team.
Ø During field action, conduct activities with the Dexcom Japan Safety and relevant teams, including identifying and storing returned recall products in the warehouse, handling them adequately, and creating field action records and reports for the Marketing Supervisor-general and Management Representative in a timely manner.
What makes you Successful
Ø You have strong expertise in Japanese regulatory requirements (J-PMD Act, QMS Ordinance, GVP) with the ability to align local and global QMS frameworks.
Ø You have proven track record in establishing, maintaining, and improving QMS, including CAPA, audits, change control, and supplier quality management.
Ø You have solid experience overseeing end-to-end quality operations, including product release, inspection, DMR/DHR review, and labeling/IFU compliance.
Ø You have deep understanding of risk management and product lifecycle quality, including handling nonconformance and continuous improvement initiatives.
Ø You have hands-on experience managing field actions and recalls, working closely with regulatory and safety stakeholders.
Ø You have strong leadership and cross-functional collaboration skills, with the ability to influence senior stakeholders and drive a quality-focused culture in a global organization.
Experience and Education
Ø Bachelor’s degree in Life Sciences, Engineering, Pharmacy, or a related field is required (advanced degree preferred).
Ø Minimum 8–12 years of experience in the medical device, pharmaceutical, or healthcare industry, with strong exposure to Quality Management Systems (QMS).
Ø At least 2–5 years of leadership experience, including managing teams or leading cross-functional quality initiatives.
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