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DEDexcom Deutschland GmbH

Warehouse Logistics Quality Specialist - German/English - Healthcare(m/w/x)

Dortmund
Full-timeWith Home OfficeExperienced

Investigating product non-conformances and executing CAPA for diabetes care technology. Experience with 21CFR Part 820 and ISO13485 required. In-house learning programs, tuition reimbursement.

Requirements

  • Experience with Product Non-Conformances, CAPA, Root Cause Analysis
  • Familiarity with Quality Systems Regulations 21CFR Part 820 and ISO13485
  • Effective communication with leadership
  • Team collaboration with minimal supervision
  • Self-driven and motivated
  • Effective achievement of departmental goals
  • Initiative to support QA initiatives
  • Improve product quality, consistency, and conformance
  • Improve production efficiency and reduce costs
  • Working knowledge of six sigma
  • Knowledge of process capability measurement tools (Cpk)
  • Knowledge of sampling plans
  • Practical use experience in production environment
  • Initial experience in quality coordination/specialist roles
  • Medical device environment experience
  • High School Diploma/Certificate or equivalent

Tasks

  • Support Dexcom Logistics and Distribution Quality Operations in EMEA
  • Process change orders and conduct non-conformance investigations
  • Execute CAPA investigations and test and product release activities
  • Work independently and collaborate with internal teams
  • Improve the effectiveness of the Dexcom Quality Management System
  • Interact cross-functionally with various departments
  • Support the European Distribution Center in Ennigerloh, Germany
  • Manage nonconforming material holds and releases
  • Monitor Tive data logger system for excursion alerts
  • Coordinate with Arvato Receiving, QA, and Dexcom EMEA Supply Chain teams
  • Provide evidence of electronic and physical containment holds and releases
  • Maintain a tracker of Arvato QA issues and drive resolutions

Work Experience

  • 4 - 8 years

Education

  • High school diploma

Languages

  • EnglishBusiness Fluent

Tools & Technologies

  • 21CFR Part 820
  • ISO13485
  • Six Sigma
  • Cpk

Benefits

Career Advancement

  • Growth opportunities
  • Career development

Learning & Development

  • In-house learning programs

Additional Allowances

  • Qualified tuition reimbursement
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Dexcom Deutschland GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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