Manufacturing Quality Engineer leading quality assurance activities for medical devices at Beckman Coulter. Collaborating with teams to ensure compliance and improve manufacturing standards.
Responsibilities
Lead non-conformance investigation for internal and customer claims in the scope of manufacturing.
Define programs for manufacturing quality improvement.
Monitor and improve quality manufacturing KPI’s.
Liaise with supplier quality team on quality topics, containment activities, corrective actions at supplier.
Execute and participate in internal audits.
Lead Material Review Board meetings.
Create and update of manufacturing-related quality system documents.
Liaise with Engineering teams on validation requirements for new and current products and processes as well as with the regional and global Q&RA organization to support the development of and ensure alignment with BEC global policies and procedures.
Requirements
Minimum of 3 years’ experience in quality manufacturing in either medical devices, automotive, aerospace industry or with background in electro-mechanical equipment production.
Working knowledge with electronic / mechanical components controls and process release and validation elements.
Working knowledge in quality management methods (8D, Six Sigma, Statistical Tools, FMEA).
Experienced in working within multi-functional, multi-regional teams.
Fluency in German and English language (written and spoken).
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