Medical Device Quality Officer Den Haag • Panda International

On behalf of our client, we are seeking a proactive and detail-oriented Medical Device Quality Officer to join a dynamic medical device organization based near Leiden. In this full-time, office-based role, you will play a key part in supporting and maintaining a robust Quality Management System (QMS) in accordance with ISO 13485 and FDA requirements. You’ll collaborate closely with cross-functional teams and contribute to quality assurance activities that directly impact patient safety and product excellence.

Company Description:
Our client is an innovative, clinical-stage medical device company focused on advancing orthopedic and spinal care. With a commitment to improving patient outcomes, they operate in a fast-paced, international environment that fosters collaboration, continuous learning, and professional development. Based in a modern workspace near Amsterdam, the team thrives on innovation, integrity, and shared success.

Essential Requirements:

• 2–5 years of experience in a Quality Assurance role within the medical device industry

• Hands-on experience with ISO 13485 and FDA

• Familiarity with QMS in a medical device manufacturing environment

• High attention to detail and excellent documentation practices

• Strong communication and interpersonal skills

• Fluent in English 

• Ability to travel within the EU for supplier audits and quality control activities

• Experience supporting audits and post-market surveillance activities

• Ability to collaborate effectively across teams including Supply Chain, Design, Validation, and Clinical

Desirable Requirements:

• Certificate in ISO 13485 and/or FDA training

• Familiarity with electronic document control systems

• Basic technical writing skills and Good Documentation Practice (GDP) knowledge

Additional insights:
This role offers a unique opportunity to make a tangible impact in a growing startup environment, with direct influence on product development and quality improvement. The company provides a work atmosphere with regular team activities, on-site amenities, and access to professional development resources. Employees are expected to work on-site 36–40 hours per week.

For more information please don’t hesitate to get in touch with Cristina Ruiz Senac at via de button "Solliciteer nu" op deze pagina.