Do you want to contribute to quality assurance in an agile medtech company, where you also get the opportunity to get interact with customers? Then we have an exciting opportunity.
We are looking for a new colleague who will play an important role in ensuring that the company meets quality and regulatory requirements while remaining agile. Your primary focus areas will be post-market surveillance, usability engineering, complaint handling and CAPA.
Visiana has developed the software BoneXpert, which uses artificial intelligence to automatically interpret a digital X-ray image of a child's hand. BoneXpert determines how old the child is according to his biological clock, and it is used for e.g in relation to growth hormone treatment and to predict how tall the child will become as an adult. This interpretation is traditionally performed by a radiologist, but our software is able to replace the radiologist's work. BoneXpert came on the market in 2009, is now sold to 160 hospitals, and is the market leader.
We imagine that you have several of the following qualifications:
- A relevant technical education
- Approx. 2-4 years of experience in quality management.
- Experience with medical devices.
- Good knowledge of ISO 13485: 2016 / MDD / MDR.
- Desire and ability to work systematically and to document the work in our quality management system.
- Interest in contact with authorities.
- Interest in contact with external quality employees.
- Interest in new technologies and in streamlining processes where it is advantageous.
- Able to work independently and also engage in a constructive interaction with your new colleagues.
- Have excellent Danish and English skills.
- Have good analytical and technical skills.
You will be given the following responsibilities:
- All aspects of post-market surveillance.
- Usability engineering related to new releases of our product.
- Management of CAPA process.
- Complaint handling. This includes ongoing statistical reporting of inquiries and their handling.
- Technical customer support.
- Opportunity for participation in expert group meetings within medical software devices of which Visiana is a member.
- Preparation of FDA approval of the product.
In the first three weeks, you will gain thorough knowledge of the product in collaboration with your new colleagues, and learn to work in our environment. 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. You will also participate in monthly expert group meetings organized by the association Medikoindustrien, where the focus is on your specific areas.
- A job with responsibility and influence and varied tasks.
- Competitive salary.
- An informal work environment in an entrepreneurial spirit.
- Good physical environment in the Research Park in Hørsholm.
- Delicious lunch arrangement in Restaurant Søhuset.
Contact Adnan Vilic to find out more at phone: +45 31558822 or via e-mail.