description du poste

OncoDNA's ultimate mission is to improve all patients' health by empowering healthcare providers, biopharma companies and researchers to deliver the promise of precision medicine. In this relentless pursuit of better care, we have been building an ecosystem of partners involved along the entire value chain – from technology providers and lab professionals to patient treatment, monitoring and reimbursement.

As part of this commitment, we are continuously working to ensure that our solutions — like the OncoDEEP Kit — can support a growing number of configurations and technologies.

Every day, our dedicated efforts focus on enhancing patient access to Precision Medicine

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?

This role might be for you

Your role

You will be responsible for the daily implementation, maintenance, and continuous improvement of our Quality Management System in compliance with ISO 13485.

You will:

• Maintain, develop, and improve the ISO 13485-compliant QMS
• Ensure quality procedures are understood and applied across the organization
• Train, support, and raise awareness of quality and regulatory requirements
• Manage documentation (procedures, records, version control)
• Prepare and support internal and external audits (notified bodies, partners, customers)
• Manage changes, non-conformities, and CAPA
• 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

Your profile

• Higher education (Engineering degree, Master's, or equivalent) in quality, regulations, or medical devices
• Proven experience in quality management for medical devices
• Strong knowledge of ISO 13485
• Solid understanding of Software as a Medical Device (SaMD) and software quality topics
• Familiarity with European regulations (IVDR)
• Comfortable working with IT / software teams (development methods, constraints, vocabulary)
• Rigorous, pedagogical, autonomous, and a strong communicator
• Able to thrive in a small, agile organization
• Based in Belgium only, closed to our HQ (Gosselies)

• Nice to have
• Experience in agile or software development environments

Why join us?

• Real impact on product quality and compliance
• Close collaboration with technical, production and software teams
• A hands-on role in a dynamic and growing structure

Interested? Apply directly only at jobs@oncodna.com

Please note this job is based in Belgium (Walloon Region) and not open to agencies