Beckman Coulter Diagnostics is seeking a Manufacturing Quality Engineer (f/m/d) to manage the quality assurance activities for manufacturing automated instruments at the Baierbrunn site near Munich, Germany. This on-site position is part of the Manufacturing Automation Organization and will involve leading non-conformance investigations, defining programs for manufacturing quality improvement, monitoring quality KPIs, liaising with supplier quality on containment and corrective actions, conducting internal audits, leading Material Review Board meetings, and creating and updating manufacturing quality system documents. You will collaborate with Engineering teams on validation requirements for new and existing products and processes and support the regional and global Q&R organization to ensure alignment with Beckman Coulter global policies and procedures. Requirements include a minimum of 3 years' experience in quality manufacturing in medical devices, automotive, aerospace, or related electro-mechanical equipment production; working knowledge of electronic/mechanical component controls and process release/validation; familiarity with quality management methods (8D, Six Sigma, statistical tools, FMEA); experience working in multi-functional, multi-regional teams; fluency in German and English. Nice-to-have: knowledge of EU and FDA regulations (QSRs, ISO 13485 or ISO 9001).
Beckman Coulter Diagnostics is seeking a Manufacturing Quality Engineer (f/m/d) to manage the quality assurance activities for manufacturing automated instruments at the Baierbrunn site near Munich, Germany. This on-site position is part of the Manufacturing Automation Organization and will involve leading non-conformance investigations, defining programs for manufacturing quality improvement, monitoring quality KPIs, liaising with supplier quality on containment and corrective actions, conducting internal audits, leading Material Review Board meetings, and creating and updating manufacturing quality system documents. You will collaborate with Engineering teams on validation requirements for new and existing products and processes and support the regional and global Q&R organization to ensure alignment with Beckman Coulter global policies and procedures. Requirements include a minimum of 3 years' experience in quality manufacturing in medical devices, automotive, aerospace, or related electro-mechanical equipment production; working knowledge of electronic/mechanical component controls and process release/validation; familiarity with quality management methods (8D, Six Sigma, statistical tools, FMEA); experience working in multi-functional, multi-regional teams; fluency in German and English. Nice-to-have: knowledge of EU and FDA regulations (QSRs, ISO 13485 or ISO 9001).
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