Staff Supplier Quality Engineer (f/d/m)

Beckman Coulter Diagnostics; München; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A leading diagnostics company located in Munich is seeking a Staff Supplier Quality Engineer. The role focuses on driving supplier performance improvement, ensuring compliance with the European Medical Device Directive, and liaising with the global Quality & Regulatory Affair teams. The ideal candidate will have a minimum of 5 years experience in the supplier quality area, fluent German and English skills, and good knowledge of related regulations. Join our team to make an impact in the field of diagnostics and life sciences.

Qualifikationen

• Minimum of 5 years experience in supplier quality area related to medical devices or automotive.
• Experienced with validation and release of electronic and mechanical components.
• Knowledge of EU, FDA regulations including ISO standards.

Aufgaben

• Drive supplier performance improvement through corrective action.
• Ensure compliance with European Medical Device Directive.
• Liaise with Quality & Regulatory Affair organization.

Kenntnisse

Supplier quality analysis

Root cause analysis

Statistical tools

Problem solving

Fluent in German

Fluent in English

Ausbildung

Bachelor's degree in relevant field

Tools

Microsoft Applications

Databases

Web-based Tools

Jobbeschreibung

Overview

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.

The Manufacturing Quality Team is seeking a Staff Supplier Quality Engineer to support our Manufacturing Automation Organization in Munich. In this role you will report into the Manager Supplier Quality. In this role, you will manage the quality assurance activities for the manufacturing of our automate instruments at our Munich Location.

Responsibilities

• Driving supplier performance improvement through root cause analysis, corrective action and supplier performance reviews;
• Ensure compliance with the European Medical Device Directive and associated regulations;
• Liaise with the regional and global Quality & Regulatory Affair organization to support the development of and ensure alignment with BEC global policies and procedures.
• Establishing and developing commodity requirements.
• Leads key supplier sourcing and qualifications processes.

Qualifications

• Minimum of 5 years experience in supplier quality area in either medical devices, automotive, aerospace industry or with background in electro-mechanical equipment production
• Experienced with electronic and mechanical components validation and release.
• Experienced with quality management methods (i.e. Six Sigma, Problem Solving, Statistical Tools)
• Knowledge of EU, FDA and related regulations including QSR’s, (FDA 21 CFR 820), ISO 13485, ISO 9001 and the EU IVDD
• Certified internal auditor ISO 9001or ISO 13485..
• Experienced in working within multi-functional, multi-regional teams
• Fluent in German and English languages.
• Good computer skills which includes Microsoft Applications, Databases 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.