Novostia is a clinical stage company founded in April 2017, in Switzerland, that is developing a breakthrough heart valve prosthesis offering superior benefits and quality of life to young adults and elderly people suffering from heart valve disease.

The QA Specialist focusses on the development, implementation, and continuous improvement of the quality system in compliance with ISO 13485. She/He also works closely with the R&D and the production teams to ensure that the documentation meets all regulatory and medical requirements.

Responsibilities and Duties

Reporting to the Quality, Regulatory and Clinical Affairs Manager, your principal duties and responsibilities will be to:

• Ensure that Quality System requirements are met in order to achieve and maintain compliance with applicable regulations.


• Lead the preparation and execution of external and internal audits.


• Lead the Management Review preparation and execution (KPIs review, trends analysis, ...)


• Manage timelines for quality system planning.


• Participate to CAPA and NCR investigations.


• Lead Documentation Management (release, storage, archiving).


• Ensure regulatory watch and inform colleagues on regulatory requirements and the impact of new and revised regulations on products and processes.


• Participate in Technical Documentation development and maintenance.


• Support compilation of relevant clinical submission


• Support labeling implementation.


• Other duties as assigned.

More information and application