QA/RA Specialist

XEOS is a start-up that is active in the field of intraoperative imaging in surgical oncology. The company is currently in the process of designing state-of-the-art PET-CT imaging systems that will be used by surgeons, oncologists, pathologists and other physicians to visualize specimens resected during surgery. The XEOS technology helps patients to avoid the need for reoperations after cancer surgery.

The XEOS team has expertise in PET-CT system design, image acquisition, image reconstruction and image processing. To support quality and regulatory activities, we are looking for a QARA specialist.

Job description

As QARA specialist you will be part of a team led by the QARA manager. You will, among others, be responsible for creating and maintaining the technical documentation of our medical device portfolio and function as the link between the QARA and R&D department.

Essential skills and experience

• Bachelor of Science (e.g. engineering, technical or scientific) or equivalent based on experience. Knowledge of statistics is a plus;
• 2 years of experience in a regulated industry;
• Knowledge or interest in international standards and regulations (e.g. ISO 13485, EU IVDR,
• FDA CFR 21);
• Experience with regulatory submissions, registrations and other compliance documentation;
• Experience with configuration management and change management processes;
• Computer literate (MS Office);
• Organization skills, multi-tasker, able to work autonomously, detail oriented;
• Fluent in English, written and spoken. Knowledge of Dutch is an advantage.

Responsibilities

• Creating and keeping up-to-date the technical documentation and related records (e.g. specifications, labelling, training);
• Regulatory product submissions and follow-up of registration processes (e.g. FDA 510(k), CE, Free Trade Certificates, testing, etc.);
• Quality system activities, including root cause analysis, CAPA, non-conformance, change management, document management, configuration management, software tool validation.

Proposal

• Competitive remuneration
• Dynamic work environment (MeetDistrict – Ghelamco Arena – Ghent)
• Become part of an enthusiastic and energetic team
• Make the difference in the start-up phase of a promising venture

Do you want to get to know us?
Please apply for this function with your most recent CV attached.