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 Control Manager to play a key role in ensuring product quality and compliance throughout our production processes.
Job purpose:
Reporting to the Operations Director, the Quality Control Manager is responsible for implementing and executing inspection and testing activities to ensure components, intermediate products, and final products comply with defined specifications, internal procedures, and regulatory requirements.
Duties and Responsibilities:
He/She is responsible, in a proactive and results-driven manner to:
- Coordinate and monitor subcontracted laboratories for outsourced testing activities to ensure that test requests, specifications, and results comply with internal requirements and regulatory standards.
- Establish and perform incoming, in-process, and final product inspections; define control plans, protocols, and inspection methods to ensure product compliance.
- Implement inspection routines and test protocols according to ISO 13485 and other applicable regulatory standards; support the review of product risks from a quality control perspective and contribute to process monitoring.
- Perform and oversee the use, maintenance, and calibration of inspection and measurement equipment, ensuring reliability and traceability of control activities.
- Author and maintain quality system documentation; manage traceability and archiving inspection records, certificates, and batch files.
- Prepare and provide documentation required for internal and external audits by notified bodies, customers, and suppliers.
Profile:
- Industrial or Civil Engineer in the fields of Mechanics, Electromechanics or Biomechanics.
- A minimum of 5 years of relevant experience in an industrial environment, in the medical device (preferred).
- Strong knowledge and understanding of risk management and quality management system principles (ideally ISO 13485 – ISO 9001 – GMP/GLP).
- Knowledge and practice of product design control and process validation according to medical device regulation (EU and USA).
- Roll-up-your-sleeves attitude, autonomous and hands-on mindset
- Excellent communication skills (written and verbally) and strong problem-solving abilities.
- High level of attention to detail, excellent organizational skills and time management.
- Fluent in French and English, written and spoken.
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.