Senior Manufacturing Quality Engineer (f/d/m)

Posted 2 Days Ago
Be an Early Applicant
2 Locations
In-Office
Senior level
Healthtech
The Role
Manage manufacturing quality assurance for automated diagnostic instruments in Munich. Responsibilities include leading nonconformance investigations, quality improvement programs, KPI monitoring, supplier corrective actions, internal audits, Material Review Board meetings, quality system projects and documentation, and validation coordination with technical operations and R&D. The role also supports regulatory alignment across global quality and regulatory organizations.
Summary Generated by Built In

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 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.

Skills Required

  • Minimum 5 years of experience in manufacturing quality within medical devices, automotive, aerospace, or electro-mechanical equipment production
  • Experience with electronic and mechanical component controls, process release, and validation
  • Working knowledge of EU and FDA regulations, including FDA 21 CFR 820, ISO 13485, or ISO 9001
  • Experience with quality management methods including 8D, Six Sigma, statistical tools, and FMEA
  • Experience working within multifunctional, multiregional teams
  • Fluency in written and spoken German and English
  • Good computer skills, including Microsoft applications, databases, and web-based tools

Danaher Corporation Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Danaher Corporation and has not been reviewed or approved by Danaher Corporation.

  • Healthcare Strength Healthcare coverage is described as comprehensive, including medical plan options alongside dental, vision, life, disability, and mental health support. Wellness initiatives and support programs such as an EAP and vaccination or fitness offerings add breadth beyond core insurance.
  • Retirement Support Retirement benefits include a 401(k) plan with employer matching and options such as pre-tax and Roth contributions. Broader financial rewards such as performance bonuses and access to equity or an employee stock purchase plan are also described.
  • Parental & Family Support Parental leave and family-building support are described as available, including maternity and paternity leave and fertility assistance. Childcare and eldercare support are also highlighted as part of the overall package.

Danaher Corporation Insights

Am I A Good Fit?
beta
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

The Company
HQ: Washington , DC
57,802 Employees
Year Founded: 1984

What We Do

Danaher is a global science and technology innovator committed to helping our customers solve complex challenges and improve quality of life around the world. A global network of more than 25 operating companies, we drive meaningful innovation in some of today’s most dynamic industries through our operating companies in four strategic platforms: Life Sciences, Diagnostics, Water Quality and Product Identification. The engine at the heart of our success is the Danaher Business System (DBS), a set of tools that enables continuous improvement around lean, growth and leadership. Through the ingenuity of our people, the power of DBS and the impact of our meaningful technologies, we help realize life’s potential in ourselves and for those we serve.

Similar Jobs

Tapestry - Coach and Kate Spade Logo Tapestry - Coach and Kate Spade

Assistant Store Manager

eCommerce • Fashion • Retail • Sales • Wearables • Design
Hybrid
München, Bayern, DEU
16000 Employees
38K-45K Annually

Nasuni Logo Nasuni

Enterprise Account Executive

Artificial Intelligence • Big Data • Cloud • Security • Software • Cybersecurity • Infrastructure as a Service (IaaS)
Easy Apply
Hybrid
München, Bayern, DEU
550 Employees

LogicMonitor Logo LogicMonitor

Field Marketing Specialist - DACH

Artificial Intelligence • Cloud • Information Technology • Machine Learning • Software
Easy Apply
Remote or Hybrid
Munich, Bayern, DEU
1100 Employees

Tapestry - Coach and Kate Spade Logo Tapestry - Coach and Kate Spade

Assistant Store Manager

eCommerce • Fashion • Retail • Sales • Wearables • Design
Hybrid
München, Bayern, DEU
16000 Employees

Similar Companies Hiring

Sailor Health Thumbnail
Healthtech • Social Impact • Telehealth
New York City, NY
20 Employees
Granted Thumbnail
Artificial Intelligence • Healthtech • Insurance • Mobile • Financial Services
New York, New York
23 Employees
OneImaging Thumbnail
Healthtech
Miami, FL
62 Employees

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account