Danaher Corporation Design Quality Assurance Engineer (m/f/d) in Munich, Germany
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 Design Quality Assurance Engineer for Beckman Coulter Diagnostics is responsible for the conformity of the design process with applicable regulation.
This position is part of the Quality Assurance department located in Munich. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.
You will be a part of the Quality Assurance team and report to the Quality Assurance Manager responsible for new product development and Design Changes from a QA perspective. If you thrive in a fast paced role and want to work to build a world-class quality organization—read on.
In this role, you will have the opportunity to:
Closely engage in R&D projects towards introduction of new products or design changes as quality representative
Proactively provide guidance to maintain and improve compliance of development projects with global and local processes
Ensure conformity of the design process with applicable regulation
Review and approve design and development documentation
Develop and execute validation plans and protocols
Generate and maintain the Risk Management Files
Drive Risk Assessments
Contribute to Risk Management activities: Identify sources of risk such as ergonomics, use error and risks associated with product characteristics
Support post-market surveillance activities
Degree in chemistry, life sciences, engineering or quality management or equivalent education gained through work experience
2+ years of experience within the regulated environment of in vitro diagnostics or medical devices
Fluent in English - written and verbal. German is a plus.
Computer skills (MS Office products)
It would be a plus if you also possess previous experience in:
Practical experience of workflows in laboratory environments
Software development process experience or practical experience with product software verification and/or validation
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.