Senior Manufacturing Quality Engineer (f/d/m)

Radiometer; München; Vor Ort; EUR 70.000 - 100.000; Vollzeit

Zusammenfassung

Beckman Coulter Diagnostics, a Danaher operating company, seeks a Senior Manufacturing Quality Engineer to join the Manufacturing Quality Team in Munich. The role focuses on quality assurance for the manufacturing of automated instruments on site, coordinating with QA, R&D, and Tech-ops to ensure compliant, efficient production.

You will lead investigations, implement quality improvements, and drive KPI enhancements while ensuring alignment with global policies.

Qualifikationen

• 5+ years of experience in quality manufacturing in medical devices, automotive, aerospace or electro-mechanical equipment production.
• Experience with electronic/mechanical components controls and process release and validation.
• Solid knowledge of EU, FDA and related regulations including QSRs, ISO 13485 or ISO 9001.
• Experience with quality management methods (8D, Six Sigma, Statistical Tools, FMEA).
• Experience working within multi-functional, multi-regional teams.
• Fluency in German and English (written and spoken).
• Proficient with Microsoft Applications, databases and web-based tools.

Aufgaben

• Lead non-conformance investigations for internal and customer claims in manufacturing scope.
• Define programs for manufacturing quality improvement.
• Monitor and improve manufacturing quality KPIs.
• Liaise with supplier quality on quality topics, containment, and corrective actions.
• Conduct internal audits and participate in QMS projects.
• Lead Material Review Board meetings.
• Coordinate with Tech-Ops and R&D on validation requirements.
• Align with regional and global Q&RA policies and procedures.

Kenntnisse

Quality manufacturing

Regulatory knowledge

Six Sigma

FMEA

Multifunctional teams

German & English

MS Office & databases

Jobbeschreibung

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Beckman Coulter Diagnostics, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory’s role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making—we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence. Learn about the Danaher Business System which makes everything possible.

The Manufacturing Quality Team is seeking a Senior Manufacturing Quality Engineer

The Manufacturing Quality Team is seeking a Senior Manufacturing Quality Engineer to support our Manufacturing Automation Organization in Munich. In this role you will report into the Manufacturing Quality Manager and be part of the Quality & Regulatory Team of the Workflow and Informatics Business Unit. You will manage the quality assurance activities for the manufacturing of our automate instruments at our Munich Location. It will be an on-site role.

In this role, you will have the opportunity to:

• 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.
• Participate in quality management system projects.
• Create and update manufacturing-related quality system documents.
• Liaise with Tech-ops and R&D departments on validation requirements for new and current products and processes.
• Liaise with the regional and global Q&RA organization to support the development of and ensure alignment with BEC global policies and procedures.

The essential requirements of the job include:

• Minimum of 5 years’ experience in quality manufacturing in either medical devices, automotive, aerospace industry or with background in electro-mechanical equipment production.
• Experience with electronic / mechanical components controls and process release and validation elements.
• Solid working knowledge of EU, FDA and related regulations including QSR’s, (FDA 21 CFR 820), ISO 13485 or ISO 9001.
• Experience in quality management methods (8D, Six Sigma, Statistical Tools, FMEA).
• Experience in working within multi-functional, multi-regional teams.
• Fluency in German and English language (written and spoken).
• Good computer skills which includes Microsoft Applications, Database and Web Based Tools.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com. Danaher is a leading global life sciences, biotechnology, and diagnostics innovator, helping to solve many of the world’s most important health challenges, ultimately improving quality of life for billions of people today, while setting the foundation for a healthier, more sustainable tomorrow. The Danaher ecosystem is made up of more than 15 businesses united by a shared commitment to innovate for tangible impact.