Manufacturing Quality Engineer (f/m/d)

Beckman Coulter Diagnostics; München; Vor Ort; EUR 55.000 - 75.000; Vollzeit

Zusammenfassung

Beckman Coulter Diagnostics in Baierbrunn near Munich seeks a Manufacturing Quality Engineer to manage quality assurance for automated instrument manufacturing. You will drive quality improvements and ensure regulatory compliance in a fast-paced production environment.

The role requires hands-on experience with QM methods and cross-functional collaboration, with fluent German and English to liaise with global teams. On-site at Baierbrunn is required.

Qualifikationen

• Minimum of 3 years’ experience in quality manufacturing in medical devices or related electro-mechanical production.
• Working knowledge of electronic/mechanical components controls and validation elements.
• Experience with quality management methods (8D, Six Sigma, FMEA).
• Fluency in German and English (written and spoken).

Aufgaben

• Lead non-conformance investigations for internal and customer claims in the scope of manufacturing.
• Define programs for manufacturing quality improvement.
• Monitor and improve quality manufacturing KPIs.
• Liaise with supplier quality on quality topics, containment activities, corrective actions at supplier.
• Execute and participate in internal audits.
• Lead Material Review Board meetings.
• Create and update manufacturing-related quality system documents.
• Liaise with Engineering on validation requirements and coordinate with global Q&R on policy alignment.

Kenntnisse

German language

English language

Jobbeschreibung

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

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.

Manufacturing Quality Engineer (f/m/d) for Beckman Coulter Diagnostics is responsible to manage the quality assurance activities for the manufacturing of our automate instruments at our site in Baierbrunn near Munich.

This position is part of the Manufacturing Automation Organization located in Baierbrunn and will be on-site. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.

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.
• 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.

The Essential Requirements Of The Job Include

• 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).

It would be a plus if you also possess previous experience in:

• Solid working knowledge of EU, FDA and related regulations including QSR’s, (FDA 21 CFR 820), ISO 13485 or ISO 9001.