Introduction:
Based in Gembloux, Intressa Vascular is a clinical-stage company developing an innovative medical implant to address life-threatening cardiovascular conditions such as aortic dissection.
Our mission is to help physicians address the devastating effect of aortic dissection by delivering next-generation endovascular treatment.
To strengthen our team, we are looking for a Quality Officer.
Job purpose:
Reporting to the Quality Lead, the Quality Officer will support the implementation and continuous improvement of the Quality Management System (QMS) in accordance with applicable regulatory requirements for medical devices (ISO 13485, EU MDR 2017/745). The role involves participation in quality operations, documentation control, audits, and compliance activities to ensure product and process quality.
Duties and Responsibilities:
He/She is responsible, in a proactive and results-driven manner to:
- Assist in the implementation and maintenance of the QMS in compliance with ISO 13485, MDR, and internal procedures.
- Support the investigation and resolution of nonconformities and deviations.
- Assist in the evaluation and processing of change requests, ensuring impact assessment and appropriate approvals.
- Prepare for and participate in internal audits and inspections by regulatory bodies and notified bodies.
- Promote a culture of quality and regulatory compliance across departments.
- Review batch records and quality control data to support product release.
Profile:
- Bachelor’s or Master’s degree in Life Sciences, Quality, Engineering, or a related field.
- Minimum 2 years of experience in a quality role within the medical device industry.
- Good knowledge of ISO 13485, EU MDR, and QMS principles.
- Familiarity with risk management (ISO 14971), validation, and document control.
- A proactive and trustworthy team player with a problem-solving attitude.
- Detail-oriented with excellent organizational and analytical skills.
- Ability to work collaboratively in cross-functional teams.
- Strong written and verbal communication skills in English and French.
Our offer:
- A challenging and diversified position within a high-potential innovative medical device company.
- A human-sized, collaborative, and respectful work environment.
- An attractive compensation package in line with the position responsibilities and your experience.