The company is a fast-growing company assisting manufacturers of In Vitro Diagnostics (IVD) and Medical Devices (MD) in coping with European and other regulations. Their objective is to provide manufacturers with practical solutions in the area of regulatory affairs and quality assurance. They help with the implementation of quality systems, technical documentation and the organization of performance evaluations (clinical studies). They are also authorized representatives for non-EU manufacturers and offer a unique solution for e-labeling, currently used by multi-billion-dollar medical device and IVD companies.
From their offices in Geel, Eindhoven, Turin and other international sites, they serve more than 200 customers worldwide.
The company’s customers and potential customers are often small or medium sized MD/IVD manufacturers or distributors. The company assists them with the implementation or improvement of their quality management system in agreement with ISO13485 and IVD and MD regulations. Depending on your experience, you will independently perform or assist colleagues in consulting activities:
You will be 50% of the time at customer sites in Belgium/Benelux and 50% working from home or from the company’s facilities in Geel. Depending on your experience you may also assist the company’s Quality Manager in the management of the company’s ISO13485 certified quality system.
The perfect candidate (M/F) has a degree in sciences or engineering and has an excellent understanding of Quality Assurance in the Medical Device environment as demonstrated by a minimum of 5 years of experience as an employee in a MD or IVD company (ISO13485 preferred; ISO17925/ISO15189 or even other ISO norms are accepted). We welcome applications of candidates with a longer (+3 years) experience in QM. Knowledge of quality and regulatory related issues in the fields of IVD development and manufacturing, sterilization, biocompatibility, electronic safety and EMC is a strong advantage. Our candidate fluently communicates (speaking + writing) in English and preferably other languages. He/she enjoys working in an international context and is willing to travel to customers, mostly within Belgium. He/she likes variation and handles several projects at the same time and understands that working in a small team requires a flexible attitude.
What is offered: