Quality Manager Medical Devices (60–100%) (M/W)
Decomplix is a compliance partner that simplifies market access for medical devices. As a legal manufacturer, Decomplix goes beyond just consulting. Proven experts guide developers and manufacturers through the CE certification. In times of more stringent regulatory hurdles, this business model provides Decomplix customers with legal protection, lower risks and shorter time-to-market. Quality management is our core competence.
You take on
- responsibility for the development and continuous improvement of Decomplix’ ISO 13485 quality management system.
- supporting our customers in quality management.
- customer support on their regulatory path (pre- and post-market).
- project management to bring the technical documentation of customer products to the point where they can obtain the CE mark for medical devices.
- a technical background and enjoy writing technical documents;
- professional experience in quality management or regulatory affairs in the Medtech industry;
- detailed knowledge of ISO 13485 and the certification processes for medical devices in Europe, ideally for «software-only» products, active medical devices or in-vitro diagnostics;
- very good knowledge of German and English, spoken and written.
- work in a company where quality management is part of the core business;
- taking responsibility, helping to form and actively shape Decomplix;
- work independently, entrepreneurially and also take on new tasks;
- doing good for patients with new technologies, contributing to innovation in Medtech.
You get the chance,
- to form a company that is on the market as a first mover;
- to support various customers and help them obtain regulatory approval;
- guaranteed to experience diverse and challenging times.
- to work in a flat structure and with flexible working hours in Bern and Biel.
We would like to get to know you. Send us your application file by e-mail to Beni Hirt, email@example.com.
Offers from recruitment agencies will not be considered.