This role supports Dexcom's high-volume warehouse operations in Ennigerloh, Germany, ensuring quality compliance for global distribution
Job Summary
This role supports Dexcom's high-volume warehouse operations in Ennigerloh, Germany, ensuring quality compliance for global distribution.
The specialist will manage non-conforming material holds, coordinate with supply chain teams, and execute CAPA investigations to maintain product safety.
Candidates must have 4-8 years of experience in a medical device environment with strong knowledge of FDA regulations and ISO standards.
Matching Summary
This role supports Dexcom's high-volume warehouse operations in Ennigerloh, Germany, ensuring quality compliance for global distribution.
Skills & Requirements
Must-have
Product Non-Conformance management
CAPA investigation execution
Root Cause Analysis expertise
21CFR Part 820 regulatory knowledge
ISO13485 quality systems familiarity
Electronic and physical containment hold
Nice-to-have
Six Sigma methodology knowledge
Process capability measurement tools Cpk
Self-driven initiative for QA improvement
Cross-functional collaboration skills
Effective communication to leadership
Key Requirements
4-8 years related experience in medical device quality
High School Diploma or equivalent required
Experience with Quality Systems Regulations 21CFR Part 820