Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
You’ll thrive in a culture of belonging where you and your unique viewpoint matter. 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. The Design Quality Assurance Engineer for Beckman Coulter Diagnostics is responsible for the conformity of the design process with applicable regulation.
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.
This position is part of the Quality Assurance department located in Großhadern (near in Munich).
This position is initially offered on a one-year fixed-term contract, with the possibility of extension or transition to a permanent role.
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
Support post-market surveillance activities
Degree in chemistry, life sciences, engineering or quality management or equivalent education gained through work experiences
W ork experience or research experience in chemistry, life sciences, engineering or quality management (+2 years)
Fluent in English - written and verbal. German is a plus.
Computer skills (MS Office products)
Practical experience of workflows in laboratory environments
Experience within the regulated environment of in vitro diagnostics or medical devices
Experience in design verification and/or validation and generation of associated protocols gained either from in house testing simulating end use or actual end use in a clinical environment