Sr Quality Assurance Specialist QMS 品質保証 医療機器

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:

• 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;

      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

    • 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: