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:
· Implementation and review of the documentation as well as review of all relevant records for compliance with process adherence and quality
· Create, review and approve the development of documentation
· Plan, manage and implement the internal reporting of risk assessment and develop appropriate QA measures
· Assist in internal audits
· Communicate with customers regarding relevant quality topics
The requirements:
· Bachelors' degree in relevant technical field e.g. biomedical engineering
· At least 5 years' experience in the development and/or life cycle projects of medical devices
· Knowledge of ISO 13485 and MDR
· Fluent German and English - spoken and written