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Quality Assurance Analyst at Dexcom
Suginami, Tokyo, Japan -
Full Time

Start Date

Immediate

Expiry Date

05 Feb, 26

Salary

0.0

Posted On

07 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Quality Assurance, QMS, Data Analysis, Process Improvement, CAPA, Manufacturing Support, Nonconformance Handling, Labeling, Device Master Record, DHR Review, Communication, Product Quality, Recall Management, Documentation, Regulatory Compliance, Inspection Activities

Industry

Medical Equipment Manufacturing

Description
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 and execute process monitoring / measurement, data analysis, process improvement and CAPA 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 Communication with Retailer/Dealer to instruct how to ensure the product quality 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 Five (5) years' experience of Quality and QMS activities in medical device / IVD industry at least
Responsibilities
The Quality Assurance Analyst will organize and manage the site management review process and support customer-related processes. They will lead process monitoring, data analysis, and support manufacturing activities from a Quality and Regulatory perspective.