QA Specialist

QA Specialist CellaVision is a global leader in digital microscopy, delivering complete solutions that combine advanced instruments, reagents, and software to support healthcare services worldwide. Our vision is clear: To elevate healthcare through the evolution of microscopy – in a sustainable way. We work at the forefront of technology and use many of the latest advances in programming, chemistry, digital imaging, and machine learning. Joining our company means that you will play an essential role in elevating healthcare through the evolution of microscopy. Location: Lund, Sweden. Job type: Full Time, Permanent. How you will contribute As QA specialist, you and your team make sure that CellaVision’ s quality management system complies with laws, regulations and standards such as IVDR, 21 CFR Part 820 and ISO 13485. Responsibilities Review quality related documentation Monitor and initiate update of quality procedures Perform/assist in CAPA investigations Perform/assist in nonconformity investigations Participate in projects and activities Perform and assess changes to e.g. QMS and products Release systems/products Perform internal audits and supplier audits Participate in external audits Assist in management reviews Handle quality issues with suppliers Run and participate in quality-related improvement projects Support various QA issues within the company What you will bring You will bring a positive attitude and a “nothing-is-impossible” mentality . When potential for improvement is identified, you are able to initiate and drive changes on a smaller or larger scale, involving internal stakeholders from different departments. At the Quality Department we strive for an open climate and a close collaboration with other departments, hence your ability to communicate and cooperate is highly valued! We also believe that you are a meticulous person who organizes and prioritizes your work efficiently and is committed to achieve set goals. Qualifications You have a B.Sc or equivalent in a relevant field You have experience within Quality Assurance for Medical Device Knowledge of ISO13485, QMSR (21CFR 820) and IVDR or MDR You have advanced level of English and Swedish, written and verbal What we offer 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 100 employees that are both passionate and ambitious. We believe that an open and friendly company culture along with employees that take initiative and responsibility is what makes us grow together. We have created an innovative working environment in a flat organization with an open-minded attitude and ability for our employees to make quick and sound decisions. We can offer you a varied, exciting and occasionally challenging work with a lot of responsibility and a great deal of freedom. This is a full-time position primarily based on-site at CellaVision’s HQ in Lund, Sweden, with the flexibility to work remotely one day per week. Diversity At CellaVision we understand not only the uniqueness of blood cells but also of people. We strongly believe in the power of diversity and recognise it as a driver of innovation. We are committed to building an inclusive culture for all our people. CellaVision is a non-discriminatory workplace where qualified applicants receive consideration for employment without regard to race, nationality, ethnic or social origin, age, religion, political orientation, sexual orientation, gender identity/expression, family or marital status, pregnancy, disability, or any other basis prohibited by law. #J-18808-Ljbffr CellaVision