Quality Assurance Specialist

The Quality Assurance team

You will be a key part of the Quality Assurance team, currently consisting of four QA Specialists. Together they make sure that CellaVision’s s quality work complies with laws and regulations. This position offers a unique opportunity to take on tasks independently and to plan your activities with a great amount of freedom. You will work in close collaboration with your team and be encouraged to bring new ideas to the table to drive change.

The Quality department consists of nine dedicated colleagues that are all passionate about quality. The Quality department is divided into three different functions; Quality Assurance, Regulatory Affairs, and Clinical Affairs supporting the global CellaVision organization.



What you will do as a Quality Assurance Specialist at CellaVision:

- Design Control support in ongoing development projects
- Monitor and initiate updating of quality routines
- Release of products
- Change Management
- CAPA investigations
- Non-conformity investigations
- Perform internal audits




What can we offer you?
CellaVision has a world-leading position in digital cell morphology and we see our employees as our primary resource for our ongoing innovation and success. Joining CellaVision means that you will surround yourself with over 200 passionate and ambitious colleagues and that you will be part of developing products that do not only help patients worldwide but also contribute to reduced environmental impact through more efficient workflows in and between laboratories.



We believe you have:

- MSc or equivalent in the relevant field
- Experience in qualified QA work within Med-tech or pharmaceuticals. If you are newly graduated, you need a strong interest in working in the Quality Assurance area.
- Knowledge within QSR (21CFR 820) and ISO 13485
- Excellent communication and English writing skills




Meritorious

- Design Control experience
- Internal auditing experience




Who you are
We believe you are a result-oriented, and ambitious person, who is dedicated to achieving set goals. You are not afraid to take initiative and contribute to your team with ideas. Because the QA team is a small team, we give our colleagues both a lot of freedom but also a lot of responsibility when it comes to independent work and owning your tasks in both success and setbacks. We apply an open climate and have a close collaboration between departments, so your ability to cooperate is something we value highly. We believe you have a well-developed ability to take on complex tasks. We believe you appreciate being part of a team where we work together and share information and solutions. We also believe you are a meticulous person who organizes and prioritizes your work efficiently and who is passionate about producing high-quality work.



Are you ready to make a difference?
Join CellaVision, put your quality skills to greater use, and help us contribute to lab efficiency and improved patient value worldwide. We need your expertise to do the job!

Apply to this job by filling in the application form and attaching your CV/personal letter. Please prepare to have your documents, such as certificates, credentials, and recommendations, for a potential interview. We review applications continuously, so please send us yours as soon as possible but no later than February 25, 2022.

This is a full-time position with start as soon as possible, based at CellaVision HQ in Lund, Sweden with new offices, good infrastructure, and commuting possibilities. To know more about the position contact Magnus Johnsson, Director Quality, at magnus.johnsson@cellavision.com. Questions about the recruitment process are answered by Caroline Herrlander, HR Specialist, at caroline.herrlander@cellavision.se. We do not accept applications via email.

Please note that you need a valid working permit in Sweden for this role.

We respectfully decline all contacts regarding additional channels, campaigns or recruitment support.