The company is a fast-growing consulting 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 locations the company serves more than 250 customers worldwide.
This is what you will be doing
As Quality Assurance Consultant you will assist IVD and MD manufacturers with different quality management system (QMS) related issues, ranging from short ad hoc assignments to the full implementation of a quality management system in a start-up company.
You maintain, develop and share your expertise and knowledge. You will be the point of contact for colleagues and customers.
You will perform consulting activities with a high degree of independence but benefiting of the company's experience and tools:
You will pro-actively follow the news and trends in the market.
This is what you will bring
The perfect candidate 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 in a MD or IVD company.
Knowledge of quality and regulatory related issues in the fields of IVD development and manufacturing is a must. Competence in sterilization, biocompatibility, electronic safety and EMC is an advantage.
Our candidate has a thorough understanding of the QMS requirements in the European regulations and in ISO13485 and has experience with notified and certified body audits. Knowledge of MDSAP and FDA QSR is a plus.
Our candidate fluently communicates in English and preferably other languages. He enjoys working in an international context and is willing to travel to customers, mostly but not exclusively within the Benelux. He likes variation and handles several projects at the same time and understands that working in a small team requires a flexible attitude.