Description
Wondering what’s within Beckman Coulter Diagnostics? Take a closer look.
At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you’ll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.
Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges.
The Senior 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 Tech-ops and R&D departments 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 5 years’ experience in quality manufacturing in either medical devices, automotive, aerospace industry or with background in electro-mechanical equipment production
+ Experienced with electronic / mechanical components controls and process release and validation elements
+ Experienced in quality management methods (8D, Six Sigma, Statistical Tools, FMEA)
+ Experienced in working within multi-functional, multi-regional teams
+ Fluent in German (B2 or higher) and English language is required
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
When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.If you’ve ever wondered what’s within you, there’s no better time to find out.
