Manager Quality Assurance

2週間前

Tokyo Dexcom

About Dexcom

Founded in , Dexcom, Inc. (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The company is the leader in transforming diabetes care and management by providing CGM technology to help patients and healthcare professionals better manage diabetes. Since the company's inception, Dexcom has focused on better outcomes for patients, caregivers, and clinicians by delivering solutions that are best in class - while empowering the community to take control of diabetes. Dexcom reported full-year revenues of $2.9B, a growth of 18% over . Headquartered in San Diego, California, with additional offices in the Americas, Europe, and Asia Pacific, the company employs over 8, people worldwide.

Meet the team:

Bring your quality and regulatory expertise to this role, with DexCom Inc. Quality teams, to establish, maintain and improve DexCom Japan's Quality Management System, (QMS) and to manage Quality Operation as Quality Assurance manager / Domestic QA manager under J-PMD Act.

Where you come in:

Based on the Japanese Regulations including J-PMD Act, Enforcement Ordinance of J-PMD Act, QMS Ordinance and GVP Ordinance, you will establish, maintain, and improve DexCom Japan's QMS.

Especially, conducting following processes.

◆QMS related activities.

  • Lead and manage document / record control process and training process with DexCom Inc. Quality team.
  • Lead and manage QMS planningprocess in DexCom Japan
  • 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 TechnicalSupport team
  • Lead and manage outsourcee / supplier / subcontractor management process with DexCom Inc. Quality team including contract management and regulatory license management
  • Lead and manage internal / external audit process with DexCom Inc. Quality team
  • Lead and manage process monitoring / measurement, data analysis, process improvement and CAPA

    • ◆Quality Operation related activities

    -Lead and manage manufacturing activities (both domestic site and foreign sites) from Quality / Regulatory perspective with relevant team

    -Establish, maintain and improve domestic manufacturing and inspection activities from QMS/QC perspective, for example;

  • 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
  • Create Device Master Record
  • Conduct DHR review

    • -Manage 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:

  • Five years' experience asQualityin medical device / IVD industry at least
  • Experience of QMS establishment, maintenance, and improvement is required
  • Experience of medical device manufacturing at final storage site defined in J-PMD Act is required
  • Experience of communication with Japanese regulatory authoritiesincluding audit response is required
  • StrongSelf-Leadership, Logical thinking and problem-solving skill
  • Strong verbal and written communication skills in Japanese (Native level) and English (Business level at least)
  • Experience of Domestic Quality Assurance manager under J-PMD Act is preferable

    • What you'll get:

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

    • Travel Required:

  • 15-25%

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