An global life sciences leader dedicated to advancing life-saving activities is seeking an R&D Quality Engineer to join their Lower Saxony site for the development of IVD devices that provide solutions to millions of people to live a healthier. The company is currently undergoing significant internal growth globally and is now securing the most elite talent on the market. If you are an individual with ambitions and a vision and wish to be part of an exciting process that will propel into the future of medical devices, then this opportunity is for you.
The role:
ยท Implementation and review of the documentation as well as review of all relevant records for compliance with process adherence and quality
ยท Create, review and approve the development of documentation
ยท Plan, manage and implement the internal reporting of risk assessment and develop appropriate QA measures
ยท Assist in internal audits
ยท Communicate with customers regarding relevant quality topics
The requirements:
ยท Bachelors' degree in relevant technical field e.g. biomedical engineering
ยท At least 5 years' experience in the development and/or life cycle projects of medical devices
ยท Knowledge of ISO 13485 and MDR
ยท Fluent German and English - spoken and written
