id: MzMwMjggMTIx

reference: 33028

documentId: 7773641

connectionPointId: 121

lastModificationDate: 1533033499106

Jobbtitel: Quality Engineer - ALTEN Life Science

Arbetsbeskrivning:
We are looking for a driven and ambitious person with a bachelor of science or equivalent. You are result-oriented, driven and have the ability to work independently as well as in teams. A quick learner is needed for this assignment as the project is ongoing with tight deadlines. The ability to handle multiple tasks is an additional success factor in this role. As a quality engineer you will work proactively with the development team to plan, develop, and deliver medical devices and combination products that are of the highest quality and also satisfies user needs. You will also ensure that the project team follow processes, procedures, ways of working and templates. As a quality engineer, you will be a link between the QA, Medical Device Regulatory Affairs and the project team and also work with other Quality engineers to drive harmonization across project and execute quality engineering initiatives. MINIMUM REQUIREMENTS: 5+ years’ experience working in development of medical devices or other relevant regulated industry 3+ years´ experience working in a Medical Device Quality or Regulatory department Extensive understanding of process for development of Medical Devices and Combination Products; MDD, ISO 13485, FDA 21 CFR 820 and FDA 21 CFR 4 Experience in establishing DHFs, Technical Files and Dossiers Good understanding for medical device technical standards; ISO, IEC FDA guidelines Excellent organizational and communication (oral and written) skills.  Ability to work on teams as well as individually Ability to be pragmatic but still be compliant to solve problems Good leadership and interpersonal skills Good technical and regulatory writing skills Fluent in English   ABOUT ALTEN At ALTEN we develop and deliver competence for world-leading companies through the most committed engineering and IT consultants. Our customers are found in industries such as Energy, Telecom, Automotive, Defence & Aerospace, Life science and Industry and we are active throughout the whole product lifecycle. As part of the ALTEN Group, we have over 24.000 employees and operations in 20 countries. It is our belief that genuine commitment is created through possibility of free choice and the opportunity to influence your own personal development. Our business model provides that possibility and this allows us to offer our customers the most committed consultants, regardless of assignments. Contact person: Group Manager Simon Levén, +46723 532 465 Please note! During the weeks 28-34, we will not be able to answer any questions. WE LOOK FORWARD TO YOUR APPLICATION!

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C3522

jobCategoriesCodes_1: http://data.europa.eu/esco/isco/C3114

jobCategoriesCodes_2: http://data.europa.eu/esco/isco/C3113

abstractJV_contact_0:
Link to the vacancy on the Swedish job board

requiredEducationLevelCode: 0

requiredYearsOfExperience: 0

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbetsgivare Namn: Alten Sverige AB

source: PES-SWEDEN