To face our future challenges - We’re hiring a Senior Quality Manager – Medical Software (ISO 13485 / SaMD) based at our HQ at Gosselies (Belgium)
Are you passionate about quality systems and excited by the challenges of medical software ?
Do you enjoy working closely with technical and production teams and having a real impact in a growing organization?
You will be responsible for the daily implementation, maintenance, and continuous improvement of our Quality Management System in compliance with ISO 13485.
Ensure quality procedures are understood and applied across the organization
Train, support, and raise awareness of quality and regulatory requirements
Participate in risk management and regulatory compliance, especially for medical software
Act as a quality partner for software teams, facilitating dialogue between quality and development
&##Higher education (Engineering degree, Master’s, or equivalent) in quality, regulations, or medical devices
Proven experience in quality management for medical devices
Solid understanding of Software as a Medical Device (SaMD) and software quality topics
Comfortable working with IT / software teams (development methods, constraints, vocabulary)
Experience in agile or software development environments
&##Real impact on product quality and compliance
Close collaboration with technical, production and software teams