Quality Assurance Analyst
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Job Location:
Monthly Salary:
Posted on:
08-11-2025
Vacancies:
1 Vacancy
Job Summary
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 were 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 weve 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. Weve already changed millions of lives and were 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. Well get there by constantly reinventing unique biosensing-technology experiences. Though weve 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:
Bring your quality and regulatoryexpertiseto this role withDexComInc. Quality teams toestablish maintain and improvementDexComJapans Quality Management System (QMS) and toexecuteasSrQAspecialist.LeadingQuality Operationispreferableexperience.
Where you come in:
Based on the Japanese Regulations including J-PMD Act Enforcement Ordinance of J-PMD Act QMS Ordinance and GVP Ordinance youwillexecute and leadDexComJapans QMSactivities.
Especially you conductfollowingprocesses.
QMS related activities
Lead document /record controlprocess and training processwithDexComInc. Quality team
Change management ofnew / revised regulatory requirements from QMS perspective withDexComJapan Regulatory Affairs and Safety team
Organize and manage site management reviewprocess andcommercial material reviewprocess
Support customer related processeswithCustomer Serviceteam andTechnicalSupportteam
Leadtheactivities:outsource/ supplier / subcontractor management process withDexComInc. Quality team including contract management and regulatory license management
Lead andexecuteinternal / external audit process withDexComInc. Quality team
Lead andexecuteprocess monitoring / measurementdataanalysisprocessimprovementand CAPA
QualityOperation relatedactivities(Preferable)
Supportmanufacturing activities (both domestic site and foreign sites) from Quality / Regulatory perspective with relevant team
Supportmaintainandimprovedomestic manufacturingandinspection activities from QMS/QC perspective forexample;
- Incoming Quality Check process and Product release decision process
- Nonconformance product handling process including reworkconcessionand ship hold
- Country specific labele-PackagingInsertand IFU establishment process
- Infrastructuremanagementand Monitoringand/orMeasurement devicemanagement processincludingperiodicalmaintenance and calibration
- Work environmentmanagement
- CreateDevice Master Record
- ConductDHR review
SupportProduct realization process and Risk management processwithDexComInc. Quality team
Communication with Retailer/Dealer to instruct how to ensure the product quality
Change management of medical device fromboth productqualityand qualityoperation perspectivewithDexComJapan Regulatory AffairsSafetyand other relevant teams
Gathertheinformation related to product quality (including occurredand/orpotential product malfunction and nonconformity) from Japanese market cooperating withDexComJapanSafety team
During Field Action conduct following activities withDexComJapanSafetyandrelevantteams
- Identifyand store returned recall product in the warehouse and handle adequately
- Create field action record and report by documentation toMarketing Supervisor-generalandManagement representativein a timely manner
What makes you successful:
You must have experience ofQC activity in medical device / IVD industry (preferable)
You must have experience of QMS establishment(preferable)maintenance andactivitiesis
You must have experience of Internal auditorand External auditor
You must leadandfacilitateProduct Realization(e.g.Risk Management: Domestic)activitiesas MAH(Preferable)
You can organizethe internaltraining asatrainer
You must have experience ofcommunication with Japanese regulatory authoritiesincluding audit response is
You have strong Self-LeadershipLogicalthinkingand problem-solving skill
You have strong verbal and written communication skills in Japanese (Native level) and English (Business level at least)
Experience and Education:
Five (5) years experience of Qualityand QMS activitiesin medical device / IVD industry at least
Travel Required:
- 5 - 15%
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.
Required Experience:
IC
Key Skills
- Test Cases
- SQL
- Quality Assurance
- Agile
- TFS
- Jira
- Software Testing
- Test Automation
- Cucumber
- QA/QC
- SDLC
- Selenium
About Company
Dexcom Continuous Glucose Monitoring is simplifying diabetes management with a small device, accurate real-time glucose readings, and proven results. No fingersticks or scanning.†
