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Warehouse Logistics Quality Specialist - German/English - Healthcare(m/w/x)
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
- English – Business 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
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Warehouse Logistics Quality Specialist - German/English - Healthcare(m/w/x)
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
- English – Business 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
About the Company
Dexcom Deutschland GmbH
Industry
Healthcare
Description
Das Unternehmen entwickelt und vermarktet Systeme zur kontinuierlichen Glukoseüberwachung für Menschen mit Diabetes.
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