Want to work with Decomplix?
Do you know someone looking for a challenging experience? Are you stimulated by the idea of building up a company that occupies a first-mover advantage on the market? Do you thrive on variety?
Decomplix simplifies market access for medical devices by offering outsourced certification in significantly less time. Developers get to concentrate on their core business of innovation, design and marketing. Decomplix takes over responsibility for obtaining and maintaining the CE mark for the product. Decomplix is a joint venture between established companies and professionals with a mission to accelerate innovation and encourage the increased breakthrough of great ideas. Decomplix is growing and is searching for a
Quality Manager mHealth & Medical Devices (60–100%) (M/W)
You take on a leading role at developing Decomplix as our Q-conscience. Your main task is to maintain our quality management system and that of our customers. You make sure that our QMS is consistently more efficient and digitized. You accompany our customers on their regulatory journey (pre- and post-market). You will also lead projects to ensure technical documentation is compliant so our customers‘ products obtain the CE mark.
You’ve got a technical background. You’re a MedTech-Insider and you have experience in quality management and regulatory affairs. You know the ISO 13485 and European certification process inside out, ideally for software as a medical device (SaMD), for active medical products or in-vitro-diagnostics. You’ve got a nose for project management and you tenaciously pursue and achieve your goals. You speak and write German and English at a high level.
You want to actively shape Decomplix to ensure our new model breaks through. You’re entrepreneurial, independent and you love to tackle new tasks. You’re convinced a good quality management system benefits customers further rather than impeding them. You’re outgoing and love to meet new people regardless of their professional status. You’re interested in new technologies such as apps, wearables and medical devices.
You get the opportunity to build Decomplix as first mover in the market. Our customers strive to achieve certification across a broad range of products in a dynamic environment. You thrive in changing, stimulating and challenging environments. At Decomplix you’ll work in a flat hierarchy with flexible working hours, based in Biel.
We would like to get to know you. Please send us a message with your application file.
Offers from recruitment agencies won’t be taken into consideration.
032 365 33 33