Quality Engineer - Medical device - Braban wallon

Our client is a company aims at developing and commercializing next generation active implantable medical devices and biosensors for the treatment of neurological disorders as well as sensory and motor rehabilitation, using a wide range of technologies such as electronics, embedded software and signal processing, biomedical engineering, mechanical engineering, material sciences and optics.

Part of a small team, you and your team are involved in the update and the improvement of the Quality System based on the ISO 13485.

You are also involved on regulatory topics and you ensure a good communication with R&D team in order to develop products respecting regulatory and quality requirements.

• You provide on-going guidance in the proper implementation of the Quality Management System
• You identify opportunities for improvement of the Quality Management System
• Set up and maintain control and document procedures by ensuring all specified quality and documentation requirements
• You write SOPs
• You perform gap analysis (standards and regulations, guidance)
• You manage CAPA and non-conformity process
• You perform internal audits
• You support the revision of technical documentation in order to assure its regulatory & quality compliance
• You assist the coordination of complaints investigation and complaint handling
• You support of the different steps for new device development: risk assessment, design control, labelling, etc.

BACKGROUND

• University or High School Degree in Electronics Engineering, Biomedical Engineering, Applied Mathematics Engineering or similar applicable to the job description
• Min. 2 years of relevant experience in QA functions in a regulated environment

HARD SKILLS

• A good knowledge of a quality assurance (ISO 13485 or 9001) and relevant standards.
• Good understanding of medical devices regulatory environment (FDA, MDR)
• Good verbal and written communications skills in English and French (speaking work environment)

SOFT SKILLS

• Passionate about Biomedical Engineering, medical devices, technology and innovation
• Thorough, hands on approach
• Showing attention to details, with the ability to cope with the complexities and tensions of a rapidly developing programme
• Able and willing to work and evolve in a start-up atmosphere
• Organisational, flexibility, adaptability and responsiveness skills

• Full-time open-ended contract and good salary package
• A friendly, dynamic and ever evolving start-up atmosphere and team
• The chance to get involved in the company evolution and in the full chain of development, from specifications to clinical investigations and market and, ultimately, help improve people’s life.

How to apply ?

If you are interested by the position, you can send your application to our recruitment partner PlusOne to :

• Caroline Franki
• cfranki@plusonesearch.be
• 010/39.21.84.