QA Officer

Delft Imaging | BCorp™; 's-Hertogenbosch; On-site; EUR 50,000 - 70,000; Full time

Benefits offered by this job

25 vacation days

Paid pension scheme

Team outings and informal gatherings

Job summary

Delft Imaging | BCorp™ is seeking a dedicated Quality Management Specialist to oversee their Quality Management System (eQMS). This role focuses on maintaining eQMS documentation, leading audits, and ensuring compliance with ISO13485 and MDR requirements.

With a strong emphasis on international collaboration and innovation, Delft offers a vibrant work environment that encourages professional growth and diversity.

Qualifications

• Minimum degree in engineering or business, or 5 years experience in quality.
• Minimum 3 years of experience in Quality Management in medical devices.
• Knowledge of ISO13485 and MDR obligations.

Responsibilities

• Manage the Quality Management System (eQMS) record and document control.
• Lead internal and external audits for ISO 13485, MDR, and IEC 62304.
• Ensure regulatory and quality documentation are maintained.

Skills

ISO13485 knowledge

English fluency

Attention to detail

Audit management

Experience with Atlassian tools

Ability to work independently

Education

Degree in engineering or business

5 years experience in Quality Management

Tools

Atlassian

Jira

Confluence

MS SharePoint

Job description

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 maintain and improve the quality management system. You will lead internal and external audits, manage and guide the QMS processes, and work with cross‑functional teams.

Responsibilities

• Manage the Quality Management System (eQMS) record and document control and release system
• Lead the execution, coordination, and follow‑up of internal and external audits, covering ISO 13485, MDR, and IEC 62304.
• Administer eQMS requests and tickets for country registration, supplier qualification, tool validation, supplier performance review, CAPA, change management, audit nonconformities, training matrices, and policy/procedure lifecycle management.
• Lead development and incorporation of AI and improvements into the eQMS. Identify and implement changes in terms efficiency and usability on the existing Atlassian platform for the eQMS
• Function as process owner for Quality processes and procedures
• Ensure all required regulatory and quality documentation are maintained, including medical device development and release records, Declarations of Conformity, CE/MDR certificates, ISO certificates, and Quality Agreements.
• Function as the Quality Management Representative
• Perform CAPA and Quality related ticket scrubs and follow up at regular intervals

Educational background and 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 in terms of Article 10. Article 14, Article 22 and Article 33 obligations and responsibilities
• 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 Confluence 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.