Senior Manufacturing Quality Engineer (f/d/m)

Danaher Corporation; München; Vor Ort; EUR 70.000 - 110.000; Vollzeit

Zusammenfassung

Beckman Coulter Diagnostics in Munich, a Danaher company, seeks a Senior Manufacturing Quality Engineer to support our Manufacturing Automation Organization on-site. You will report to the Manufacturing Quality Manager and contribute to the Quality & Regulatory Team within Workflow and Informatics.

You will lead non-conformance investigations, define quality improvement programs, monitor KPIs, and coordinate with supplier quality, audits, and the global Q&R alignment to Danaher policies.

Qualifikationen

• Minimum 5 years of quality manufacturing experience in medical devices or related industries.
• Experience with electronics/mechanical components controls and validation.
• Solid knowledge of EU, FDA regulations (QSR/21 CFR 820) and ISO quality standards.
• Experience with quality methods (8D, Six Sigma, FMEA).
• Experience in cross-functional, multi-regional teams.
• Fluency in German and English (written and spoken).

Aufgaben

• Lead non-conformance investigations for manufacturing-related issues.
• Define programs for manufacturing quality improvement.
• Monitor and improve quality manufacturing KPIs.
• Liaise with supplier quality on containment, corrective actions and audits.
• 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.
• Collaborate with Tech-ops and R&D on validation requirements.
• Coordinate with regional and global Q&R to align with Danaher policies.

Kenntnisse

Quality manufacturing experience

German & English fluency

Six Sigma / 8D / FMEA

Tools

Microsoft Office

Databases / Web-based tools

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 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 instrumentsat ourMunich 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.

For more information, visit www.danaher.com.