Kvalitetsingenjör/Quality engineer to innovative medtech company
C-Rad Positioning AB / Logistikjobb / Uppsala
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hela Sverige Visa alla jobb hos C-Rad Positioning AB i Uppsala Your contribution to our success: The Quality Engineer is responsible for reviewing and analyzing complaint data, performing root-cause-investigations to establish corrective action plans and implement corrective actions, developing and performing test methods for product testing and investigations, writing and updating procedures as required to ensure the quality system is compliant with regulations including the FDA Quality System Requirements (QSR), ISO 13485, Canadian Medical Device Regulations (CMDR), and the Medical Devices Directive (MDD) / Medical Device Regulation (MDR). Perform all job duties while adhering to HIPAA requirements.Qualification: 2 to 3 years' experience as a Quality Engineer in the medical device industryBA/BS degree in science or another technical fieldMedical Device Quality System Knowledge Including 21 CFR Part 820 (QSR) & ISO 13485Demonstrated skills in statistical analysisStrong computer skillsIndividual must have a hands-on approachExperience participating in internal and external audits (e.g., FDA, Notified Body, Supplier)Strong organizational and time management skillsExperience with CAPA, complaint investigation, field action processes and risk managementTeam PlayerRecognized as a technical leader within the company and engenders trust when working with customers or suppliersCapable of leading a Continuous Improvement Team, CAPA team, or working with a customer or supplier to resolve product quality issuesWorks effectively on cross functional teams to establish appropriate processes pertaining to qualityExcellent written and oral communication skills Ability to formulate responses to common inquiries or complaints from customers and regulatory agenciesAbility to review, analyze, summarize, and interpret data; draw conclusions and make appropriaterecommendations and decisions; write reports; and give oral presentationsFluent in English and SwedishWhat we offer you:Interesting position in an innovative, fast growing companyYoung team within a global positioned organizationShort decision-making processes supporting an efficient working environmentHigh level of individual responsibility and attractive possibilities for self-developmentOur core values are: Professional, Organized and HonestyC-RAD is a global Medtech Company with its headquarter in Uppsala. We are developing and selling innovative solutions for cancer treatment. The focus is on a cutting-edge technology for patient positioning, monitoring and imaging within radiation therapy. We are market leader in our field and have established a global presence. C-RAD is a stock listed company at NASDAQ Stockholm.We are looking for a Quality Engineer to strengthen our team.Candidate assessment is done on a rolling basis.
Publiceringsdatum2019-04-04Så ansöker duSista dag att ansöka är 2019-05-03
Ange följande referens när du ansöker: Quality Engineer
FöretagC-RAD POSITIONING AB
KontorsadressBREDGRÄND 18
Jobbnummer 4712769
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