Quality Engineer

le contenu du travail

SYNERGIA MEDICAL is a MedTech company focusing on neural stimulation as a game changer in treatment of neurological disorders and developing its first implantable neurostimulator for personalized treatment of epilepsy.

Based in Mont-Saint-Guibert (30km from Brussels, Belgium) Synergia Medical is searching for a dynamic and enthusiastic person to strengthen the team. For more information about the company and the technology, please contact us via carole.monterrat@synergiam.com.

Synergia Medical offers a French and English-speaking environment, culturally diversified, and located in the heart of Europe, within easy reach of several European Capitals.

To strengthen the team, we’re looking for a (m/f):Quality Engineer

Your role

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 (see job purpose).

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.

Your responsibilities

• 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.

Requirements

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

We offer

• 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.
• To apply please send your CV with short covering letter by e-mail to info@synergiam.com. For more
• information, contact us or visit our website at synergiam.com