Do you value quality assurance within medtech, but are missing more direct contact with customers, and to actually see how your work impacts others?

Then we have an exciting opportunity for you!

We are looking for a new colleague, we will play an important role in assuring that the company lives up to quality- and regulatory requirements, while still remaining agile. Your primary focus will be on post-market surveillance, usability engineering, complaint handling and CAPA.

Visiana has developed the software BoneXpert which through artificial intelligence automatically interprets a digital X-ray of a child's hand. BoneXpert determines how old the child is according to its biological clock, and this is used e.g. in relation to growth hormone treatment, and to predict how high the child will become as an adult. This interpretation was traditionally performed by a radiologist, but our software is able to replace the radiologist's work. The software is already Class I CE-marked, but will within the next 2-3 years switch to Class IIa under MDR.

Relevant qualifications

• A relevant technical education.

• 2-4 years of experience from Medtech industry.

• Experience with medical devices.

• Good knowledge of ISO13485:2016 / MDD / MDR.

• Interest and willingness to work systematic and document work in our QMS.

• Interest in contact with authorities, customers and external quality assurance experts.

• Interest in new technologies and to streamline processes where it makes sense.

• You can work independently and also engage in a constructive interaction with your new colleagues.

• You have excellent English skills .

• You have good analytical and technical skills.

Fields of responsibility

• All aspects of post-market surveillance.

• Usability engineering related to release of new versions of our product.

• Handling of CAPA-proces.

• Complaint handling, hereunder also do statistical reporting of incidents, feedback and handling.

• Technical customer support.

• Preparation for audits related to MDR and FDA

In the first three weeks, you will build a thorough knowledge of the product in collaboration with your new colleagues and learn to work with our tools. You will then build up the remaining PMS documentation so that regular reporting can be done (including CAPA and complaint handling). In the learning phase, the focus will gradually shift from internal documentation to you helping customers and contributing to improved user experience at the product level. The work typically takes place in groups of 2-3 people, possibly. with the assistance of an external consultant.