QA Design Control Specialist
CellaVision AB / Civilingenjörsjobb / Malmö
2019-09-27
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hela Sverige Are you good at taking initiative and are self-driven? Do you have experience in working with qualified QA work, used to working with the full breadth of Quality Assurance and feel ready to take the next step in your career? CellaVision is now looking for a QA Specialist with a focus on Design Control. Does the position sound exciting? Then it could be you we are looking for!
CellaVision's quality department is growing and is now in need of strengthening the team with a QA Design Control Specialist. As a QA Design Control Specialist, your main task is to ensure that work on development projects complies with laws and regulations. You will be part of an experienced team of nine people and report to the QA Manager.
As a QA Design Control Specialist, you will implement, operate and develop the Design Control area towards our development projects. You will work with our research and development department and will be involved in developing strategies in design control. You will also work on the release of CellaVision's products. The job may also involve handling quality issues with suppliers, as well as participating in audits. We conduct a certified ISO 13485 operation where we meet FDA's requirements 21 CFR part 820. Our documentation base is administered via an electronic tool. CellaVision's products are manufactured by contract manufacturer in Sweden.
Key tasks as QA QA Design Control Specialist
• Participate in development projects
• Change management of our existing products
• Support to contract manufacturer
• Initiate and monitor updating of quality procedures
• Participate in investigations of non-conformities, complaints and CAPAs
• Release of products
Qualifications
• MSc or equivalent in the relevant field
• 2-5 years of experience in qualified QA work with similar tasks
• You are used to summarizing your work in report form and express yourself freely in both speech and writing in English and Swedish.
• Knowledge in QSR (21CFR 820)
• You have worked with ISO 13485 before
• Well experienced in both reading and creating quality management documents.
Who you are
As a person you are meticulous, attentive to details and make sure nothing is left to chance. You work with integrity and take responsibility for your own tasks in both success and setbacks. You work independently and we believe you appreciate being part of a team where you work together and share information and solutions. You have a well-developed ability to review complex tasks and prioritize them at a high pace.
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 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 position is fulltime and based at CellaVision HQ in Lund, Sweden with new offices, good infrastructure and commuting possibilities.
Care to join?
Submit your application including CV, attachment letter. We will work with continuous selection and interviews, so please send your application as soon as possible. We do not accept applications via email.
To know more about the position, please contact the responsible recruiting manager Magnus Johnsson, via e-mail:
magnus.johnsson@cellavision.se or telephone +46 46 460 16 48
Questions about the recruitment process contact Caroline Herrlander HR Specialist, at
cahe@cellavision.seWe decline all contact regarding services in advertising, consulting or recruitment.
Varaktighet, arbetstid
Heltid Anställningstid enligt överenskommelse
Publiceringsdatum2019-09-27ErsättningLön enligt överenskommelse
Så ansöker duSista dag att ansöka är 2020-03-15
Klicka på denna länk för att göra din ansökanFöretagCellavision AB
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Cellavision AB (org.nr 556500-0998),
http://www.cellavision.com/en/ Arbetsplats CellaVision
Jobbnummer 4873813
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