Leuven, Flemish Region, Belgium
Commercially driven professional with deep, hands‑on experience in product launches and the global commercialization of medical devices, effectively bridging quality, innovation, and market success. A fast‑moving, forward‑thinking change agent who strengthens organisational performance by continuously evolving operating models and the Quality Management System. Combines sharp analytical insight with strong stakeholder management and negotiation skills. Lead and coordinate quality engineering activities for product design, development & manufacturing of medical devices under Design Controls (EN ISO 13485:2016, EU regulations on Medical Devices 2017/745 & 746, 21 CFR 820). Inspiring mentor and experienced people manager of multidisciplinary teams.
Lead multi-site cross functional project teams in the implementation of the new IVDR/2017 regulation and ISO13485:2016 standard, involving changes in the manufacturing and distribution organization.
The line management of the R&D department and the coordination of the engineering activities for product design, development and manufacturing of orthopaedic implants (class III).
Materialise' mission is to innovate product development resulting in a better and healthier world through its software and hardware infrastructure and in-depth knowledge of additive manufacturing.
GymnaUniphy is a key supplier of innovative and high quality products for the medical and wellness market. GymnaUniphy offers a complete range of medical equipment (physio therapy and rehabilitation market) and wellness devices (fitness, professional sports, beauty market). The GymnaUniphy devices are known for their user comfort, functionality, durability and quality. The top brands 'gymna' and 'uniphy' have been enjoying an excellent reputation in the physio therapy market for more than 30 years and are distributed in more than 70 countries.