Sr Quality Assurance Analyst 品質保証

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

Bring your quality and regulatory expertise to this role, with DexCom Inc. Quality teams, to establish, maintain and improvement DexCom Japan’s Quality Management System, (QMS) and to execute and lead Quality Operation as Quality Assurance Sr QA specialist.

Where You Come In

Incoming Quality Check process and Product release decision process

Nonconformance product handling process including rework, concession and ship hold

• Based on the Japanese Regulations including J-PMD Act, Enforcement Ordinance of J-PMD Act, QMS Ordinance and GVP Ordinance, you will execute and lead DexCom Japan’s QMS activities.
• Especially, you conduct following processes.
• QMS related activities
• Lead document / record control process and training process with DexCom Inc. Quality team
• Change management of new / revised regulatory requirements from QMS perspective with DexCom Japan Regulatory Affairs and Safety team
• Organize and manage site management review process and commercial material review process
• Support customer related processes with Customer Service team and Technical Support team
• Lead the activities: outsource / supplier / subcontractor management process with DexCom Inc. Quality team including contract management and regulatory license management
• Lead and execute internal / external audit process with DexCom Inc. Quality team
• Lead and execute process monitoring / measurement, data analysis, process improvement and CAPA
• Quality Operation related activities
• Support manufacturing activities (both domestic site and foreign sites) from Quality / Regulatory perspective with relevant team
• Support maintain and improve domestic manufacturing and inspection activities from QMS/QC perspective, for example;
  

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

Create Device Master Record

Conduct DHR review

• Support Product realization process and Risk management process with DexCom Inc. Quality team
• Communication with Retailer/Dealer to instruct how to ensure the product quality
• Change management of medical device from both product quality and quality operation perspective with DexCom Japan Regulatory Affairs, Safety and other relevant teams
• Gather the information related to product quality (including occurred and/or potential product malfunction and nonconformity) from Japanese market cooperating with DexCom Japan Safety team
• During Field Action, conduct following activities with DexCom Japan Safety and relevant teams
  
  

Identify and store returned recall product in the warehouse, and handle adequately

Create field action record and report by documentation to Marketing Supervisor-general and Management representative in a timely manner

What Makes You Successful

• You must have at least five (5) years of experience of Quality and QMS and QC activities in medical device / IVD industry.
• You must have experience of QMS establishment(preferable), maintenance, and activities is required
• You must have experience of Internal auditor, and External auditor (preferable)
• You must lead and facilitate of Product Realization (e.g. Risk Management: Domestic) activities as MAH
• You must organize of the internal training as a trainer
• You must experience of communication with Japanese regulatory authorities including audit response is required
• You must be strong Self-Leadership, Logical thinking and problem-solving skill
• You have strong verbal and written communication skills in Japanese (Native level) and English (Business level at least)
  
  

What You’ll Get

• A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community .
• A full and comprehensive benefits program.
• Growth opportunities on a global scale.
• Access to career development through in-house learning programs and/or qualified tuition reimbursement.
• An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.
  
  

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.