We are seeking a detail oriented and well organized QA manager with a focus on medical devices and healthcare

About us

Delft Imaging Systems is a leading innovative medical imaging solutions and healthcare technologies provider. Headquartered in ‘s-Hertogenbosch, the Netherlands, we have built a strong reputation for our cutting-edge products and services that contribute to diagnosing various diseases, particularly in resource-limited settings. Our expertise lies in radiology, where we have developed an array of advanced digital X-ray systems that offer reliable and affordable diagnostic capabilities.

Additionally, we provide artificial intelligence software and mobile clinics for various applications, from X-ray clinics to gynaecology clinics. Operating in over 85 countries, we actively collaborate with governments, non-profit organizations, healthcare institutions, and United Nations agencies to implement sustainable screening programs and improve healthcare worldwide.

Role

In this role, you will be responsible for developing, implementing, and maintaining quality management systems in compliance with ISO 13485, and other global medical device standards. You will oversee product quality, risk management, and regulatory compliance, ensuring adherence. Key responsibilities include leading audits (internal and external), driving continuous improvement initiatives, managing CAPA processes, and collaborating with cross-functional teams to ensure product safety and efficacy.

Responsibilities

  • Control and release of documentation into the QMS
  • Change management implementation
  • Investigate country registration options for Delft Imaging products and ensure compliance to third party country registration requirements
  • Responsible for executing and follow up on internal and external audits
  • Administer QMS system for supplier approval, supplier review, CAPA, audit nonconformities, training matrixes, policy and procedure review
  • Ensure all applicable regulatory product documents from suppliers are maintained
  • Declaration of conformity, CE certs, ISO certs, and Quality Agreements
  • Communicate with and external auditors and other regulatory authorities as required
  • Function as the Quality Management representative

Educational background & skills

  • Minimum degree in engineering or business, or 5 years’ experience in the field of quality in lieu of this
  • Minimum 3 years of experience in Quality Management in the medical devices field
  • Knowledge and understanding of ISO13485 and MDR – Article 14, Article 22 and Article 33; and Post Market related obligations under MDR Article 83 to Article 86
  • Fluency in English in writing and speaking is a must, any other languages are a plus
  • Experience with managing third party audits
  • Proficient in use of tools including Atlassian, Jira and MS SharePoint
  • Adaptive with a strong attention to detail
  • Can work independently, but also comfortable working in a small team

Why us?

The opportunity to work in an international, multi-cultural and ambitious team with more than 20 different nationalities. We offer a dynamic work environment in which everyone is encouraged to learn, grow and take ownership. Delft is growing rapidly and with that we foster innovation and personal growth. We encourage following trainings and courses which fit your and the company’s ambition.

What we offer you

  • • We are a dynamic, growing company that encourages innovation and growth
    • Have a direct positive impact on global healthcare
    • 25 vacation days and 1 diversity day
    • An excellent pension schema, completely paid for by Delft
    • Flexibility, ownership, autonomy and freedom in your job
    • Multiple team outings per year and regular informal get togethers

Diversity & Inclusion

At Delft Imaging, we reflect the diverse world we serve. We value equity and inclusion, as our team’s multicultural experiences fuel creativity and broaden perspectives. Together, our inclusivity embodies our vision of global health equity.

We welcome qualified applicants of all backgrounds, especially those from diverse and underrepresented ethnicities and groups.

Do you recognize yourself in the above profile? We would love to schedule an introductory meeting! Send your CV and mandatory motivation letter to hr@delft.care.