We have partnered with an outstanding medical device company based in Munich who are looking to bring on a Junior Quality Engineer. This is an excellent opportunity for a hardworking and motivated graduate looking to break into the Medical Device Industry.
As Junior Quality Engineer, you will be part of the team for Quality Management and Regulatory Affairs. As an allrounder, you will support the development, production, and servicing of our innovative biomedical imaging devices for one product group. Your work influences the quality of our product and ensures timely market access. You will get exposure to all core quality processes of the company’s ISO 13485-certified quality management system as a medical device manufacturer and your responsibility will cover the entire lifecycle of our products.
Teamplay and communication are key - as you will work closely with the development team and support teams such as production and service, to achieve product compliance most effectively. Furthermore, you will help the quality team to keep the quality management system lean and effective by identifying and understanding new regulatory requirements as well as maintaining and improving the digital tool landscape for quality management.
Principal duties and responsibilities include the following:
- Ensure compliance of all core quality processes
- Support internal audits and reviews to improve core quality processes
- Support the R&D team in the creation of regulatory-compliant device documentation
- Development of system, hardware, and software test procedures
- Support of verification and validation of medical software
- Support the training of colleagues on quality processes
- Maintain and improve the tool landscape used for quality-related processes
- Support the Service and the Applications teams in managing complaints and CAPAs
- Your qualifications / profile the candidate should have (or be currently enrolled in) a degree in engineering or life sciences, but other degrees may be considered.
If you are interested in find out more about this vacancy, please reach out to me at: Jack.Watterson-Burnell@Medella.life