QA Professional
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Hørsholm
On behalf of Visiana in Hørsholm, People In Action is looking for a
Do you want to significantly boost your career within quality assurance for medical devices? Here you will experience the entire quality assurance process and get the overall overview.
You will join a dedicated team, and become a part of the scaling up and expanding the unique software product BoneXpert
We are looking to expand QA with a profile who can maintain and further develop the electronic quality management system. Your primary focus will be on organizational- and product specific quality assurance. Depending on your skill-set and preferences, it is also possible to include responsibilities related to regulatory affairs and internal audits.
What Visiana does
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 tall the child will become as an adult. The software is already CE-marked as Class l under MDD but will within the next 2-3 years switch to Class IIa under MDR.
Your fields of responsibility
Your qualifications
Visiana is situated in DTU Science Park, Hørsholm – north of Copenhagen. You will join an innovation thinking and knowledge sharing team and be a part of an exciting journey within the medtech field.
Are you interested?
Please send your CV to
Applications are evaluated continuously
QA Professional within Medical Devices - get full insight in all steps related to FDA & EU regulation
Do you want to significantly boost your career within quality assurance for medical devices? Here you will experience the entire quality assurance process and get the overall overview.
You will join a dedicated team, and become a part of the scaling up and expanding the unique software product BoneXpert
We are looking to expand QA with a profile who can maintain and further develop the electronic quality management system. Your primary focus will be on organizational- and product specific quality assurance. Depending on your skill-set and preferences, it is also possible to include responsibilities related to regulatory affairs and internal audits.
What Visiana does
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 tall the child will become as an adult. The software is already CE-marked as Class l under MDD but will within the next 2-3 years switch to Class IIa under MDR.
Your fields of responsibility
- Maintaining the effectiveness of the eQMS.
- Product realization (without responsibility for clinical aspects, usability and PMS).
- Handling documentation packages for FDA /Notified Body and other authorities.
- Communication with representatives for different countries.
Your qualifications
- A relevant technical education.
- 2-4 years of experience from Medtech industry.
- Experience with medical devices.
- Good knowledge of ISO13485:2016 / MDD / MDR
- Knowledge of FDA 21 CFR part 820
- Interest and willingness to work systematically and document work in the eQMS.
- 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 engage in a constructive interaction with your colleagues.
- You have excellent communication skills.
- You have good analytical and technical skills.
Visiana is situated in DTU Science Park, Hørsholm – north of Copenhagen. You will join an innovation thinking and knowledge sharing team and be a part of an exciting journey within the medtech field.
Are you interested?
Please send your CV to
Applications are evaluated continuously
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Hørsholm.
Jobbet er oprettet på vores service den 17.9.2021, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Øvrige
- Hørsholm
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