Sr Quality Assurance Analystãå質ä¿è¨¼
Sr Quality Assurance Analystãå質ä¿è¨¼
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Job Description
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 regulatory expertise to this role with DexCom Inc. Quality teams to establish maintain and improvement DexCom Japans Quality Management System (QMS) and to execute as Sr QA specialist. Leading Quality Operation is preferable experience.
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 Japans 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 (Preferable)
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:
- Five (5) years experience of Quality and QMS activities in medical device / IVD industry at least
- Experience of QC activity in medical device / IVD industry (preferable)
- Experience of QMS establishment(preferable) maintenance and activities is required
- Experience of Internal auditor and External auditor
- Lead and facilitate Product Realization (e.g. Risk Management: Domestic) activities as MAH (Preferable)
- Organize the internal training as a trainer
- Experience of communication with Japanese regulatory authorities including audit response is required
- Strong Self-Leadership Logical thinking and problem-solving skill
- Strong verbal and written communication skills in Japanese (Native level) and English (Business level at least) in order to liaise with Global and Local vendors/entities.
What youll 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%
Experience and Education Requirements:
- Prefers to have a Bachelors degree and a minimum of 5 8 years of related experience.
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:
Senior IC
Employment Type
Full-Time
