QA Specialist

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. As QA Specialist you will for example: · 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. 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. Ready to apply? Apply as soon as possible via our career site. We will work with continuous selection and interviews, so please send your application as soon as possible. We do not accept applications via email. Diversity is in our blood 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. More about us CellaVision® was established in Sweden in 1994 with a vision to simplify, standardize, and digitize the manual analysis of blood cells in hematology laboratories. The company’s long-term success is a result of our commitment to innovation. Our goal is to provide value to patients, customers and distributors by incorporating smart solutions into everything we do. Our research and development focus on offering superior analytical and diagnostic certainty by creating an ecosystem that combines reagents with hardware and software. Today CellaVision has 250 employees, with global Headquarters in Lund, Sweden. The company has market support offices in 16 markets and a presence in over 40 countries with reagent development and manufacturing performed in Martillac, France. For more information visit www.cellavision.com To know more about the position, please contact hiring manager Sofie Månsson, via e-mail: sofie. [email protected] We decline all contact regarding services in advertising, consulting or recruitment. Department Quality CellaVision' s Headquarters About CellaVision CellaVision offers the latest innovations for analyzers, instruments, reagents, and software used in hematology laboratories. Our automated workflows cover blood and body fluid samples from humans and animals in hematology laboratories of every size. With CellaVision, you leap into the future of healthcare. Founded in 1994