Staff Supplier Quality Engineer | Elektroingenieurwesen (m/w/d)
Beckman Coulter GmbH
Job Summary
This role involves ensuring the quality assurance of automated instruments manufactured in Munich, specifically focusing on supplier quality management within the life sciences and diagnostics sector. The Staff Supplier Quality Engineer will be responsible for driving supplier performance improvements through rigorous root cause analysis, corrective actions, and regular performance reviews. A key aspect of the role is ensuring strict compliance with the European Medical Device Directive and related regulations, including ISO 13485 and FDA QSRs. The ideal candidate will possess extensive experience (minimum 5 years) in supplier quality within regulated industries like medical devices, automotive, or aerospace, coupled with expertise in validating and releasing electronic and mechanical components. This position offers the opportunity to work within a global leader, Beckman Coulter Diagnostics, leveraging the Danaher Business System for continuous improvement and making a tangible impact on patient health.
Required Skills
Education
Certified internal auditor ISO 9001 or ISO 13485
Experience
- Minimum of 5 years experience in supplier quality in medical devices, automotive, aerospace, or electro-mechanical equipment production
- Experience with electronic and mechanical components validation and release
- Experience with quality management methods (i.e. Six Sigma, Problem Solving, Statistical Tools)
- Experience in working within multi-functional, multi-regional teams
Languages
Additional
- Knowledge of EU, FDA, and related regulations including QSR’s (FDA 21 CFR 820), ISO 13485, ISO 9001, and the EU IVDD.
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