Manager Quality Assurance at Dexcom

Tokyo, , Japan -

Full Time

Start Date

Immediate

Expiry Date

07 Sep, 26

Salary

0.0

Posted On

10 Jun, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

QMS Management, J-PMD Act Compliance, GVP Ordinance, CAPA, Internal and External Auditing, Supplier Quality Management, Risk Management, Product Release Decision, DMR/DHR Review, Field Action Management, Change Control, Cross-functional Leadership, Regulatory Compliance, Quality Control, Medical Device Regulations, Labeling and IFU Compliance

Industry

Medical Equipment Manufacturing

Description

The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health. We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us. Meet the Team: You will establish, maintain, and improve Dexcom Japan’s QMS based on Japanese Regulations including the J-PMD Act, Enforcement Ordinance of J-PMD Act, QMS Ordinance, and GVP Ordinance. Where you Come In: 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. 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. Product realization process and risk management process with the Dexcom Inc. Quality team. Communication with retailers and dealers to ensure product quality. Change management of medical devices from both product quality and qualty operation perspectives with the Dexcom Japan Regulatory Affairs, Safety, and other relevant teams. 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. 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: You have strong expertise in Japanese regulatory requirements (J-PMD Act, QMS Ordinance, GVP) with the ability to align local and global QMS frameworks. You have proven track record in establishing, maintaining, and improving QMS, including CAPA, audits, change control, and supplier quality management. You have solid experience overseeing end-to-end quality operations, including product release, inspection, DMR/DHR review, and labeling/IFU compliance. You have deep understanding of risk management and product lifecycle quality, including handling nonconformance and continuous improvement initiatives. You have hands-on experience managing field actions and recalls, working closely with regulatory and safety stakeholders. 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: Bachelor’s degree in Life Sciences, Engineering, Pharmacy, or a related field is required (advanced degree preferred). Minimum 8–12 years of experience in the medical device, pharmaceutical, or healthcare industry, with strong exposure to Quality Management Systems (QMS). At least 2–5 years of leadership experience, including managing teams or leading cross-functional quality initiatives. To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications. #DexcomJapan Since 1999, Dexcom has simplified and revolutionized diabetes management, positively impacting millions worldwide. At Dexcom, we're more than just a medical device company; we're a collective of visionary thinkers, trailblazers, and problem solvers. Our mission transcends the ordinary. We aim to revolutionize healthcare, one groundbreaking technology at a time.

Responsibilities

Establish and maintain Dexcom Japan's Quality Management System in accordance with Japanese regulations and global frameworks. Lead quality operations including manufacturing oversight, product release, and the management of field actions and recalls.