JUNIOR QM MANAGER, MEDICAL DEVICES (FULL TIME / HALF TIME)
Platomics develops a global marketplace for personalized medicine to make the future of molecular diagnostics available today. We are a young vibrant team and apply the most advanced computing technologies to enable big data processing and analysis in healthcare. We are bioinformaticians, genetics researchers, software developers and mathematicians. Contact us if you love to code and work with other developers to build meaningful products.
As a Junior QM Manager you:
Support in improvement and maintenance of our quality management system according to ISO 13485, including internal audits
Support in examination of the conformity and taking part in the conformity assessment
Support in the certification process of our medical software products, communication with responsible regulatory authorities (national/international) as well as with notified bodies
Support in risk management according to ISO 14971
Collaborate with related departments
Digital documentation (product and process related)
Administration of document management systems
Technical or scientific degree, e.g. biomedical engineering, informatics
Knowledge on Quality Management, in particular ISO 13485
European medical device regulations
Sense of responsibility, reliability, high carefulness and accuracy in the way of working
Taking actions purposefully and structured
Very good German and English language, spoken and written
Self-organizing, meeting deadlines
Knowledge on certification process for medical device software
Knowledge on further relevant standards (IEC 62304, ISO 14971 and others)
Knowledge on the In Vitro Diagnostic Device Regulation IVDR
Knowledge on Genetic Testing
Familiarity with Atlassian Jira and Confluence
An interdisciplinary and dedicated team
Exciting challenges in a fast evolving domain
Opportunity to work on cutting-edge technologies
A flexible work schedule
Convenient office location close to U1, U2 and U4 metro station Karlsplatz in Vienna
You’ll earn a salary starting at a minimum of EUR 27.846 gross per year for fulltime/ career entry level (according to IT-KV 2021). Willingness for over-payment is given for candidates with proper experience and/or qualifications.
If you are interested in strengthening our team, please e-mail your CV.
Platomics´ office is very conveniently located close to the metro station of U1, U2 and U4 Karlsplatz.
Apply via: firstname.lastname@example.org or call +43 660 222 03 95