Senior Manufacturing Quality Engineer (fdm)
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Job Summary
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 Danahers 15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.
Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers 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 laboratorys 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 makingwe 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 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 KPIs.
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 QSRs (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 well accelerate the real-life impact of tomorrows 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.
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Required Experience:
Senior IC
About Company
WHO WE ARE We are a global science and technology innovator committed to helping customers solve complex challenges and improving quality of life around the world. These are the moments that make a difference. Performing a delicate operation on an unborn baby. Minimizing waste at ever ... View more
