With over 45'000 consultants around the world and revenue of EUR. 2.9 Bn, the Altran Group is the undisputed global leader in Engineering and R&D services (ER&D).
In Switzerland, Altran employs more than 250 consultants and aims towards large growth with offices located in Zürich, Basel, Lausanne and Geneva.
Altran deploys its expertise particularly in : - Life Sciences (Pharma, Biotech, and Medical Devices),- Industry, Aerospace, Automotive, Energy, Railways,- Financial Services : P&C Insurance, Health Insurance, Reinsurance, Banking- Telecoms- Public sectorOur offerA permanent contract with the leader in innovation and high-tech engineering consulting A multi-stage model with career opportunities through specialization prospects with over 250'000 consultants around the world and a Group revenue (Altran / CapGemini) of EUR.
17 Bn, the Altran Group is the undisputed global leader in Engineering and R&D services (ER&D) In Switzerland, Altran employs more than 400 consultants and aims towards large growth with offices located in Zürich, Basel, Lausanne and GenevaYour roleResponsible for the successful delivery of MDR Change projectsImplement activities related to Quality, Design, Verification and Validation Lead all areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Complaints, Nonconforming Materials, Risk Management, etc.
Improve the Design Control and Risk Management processes Conduct Process Failure Mode and Effects Analysis (PFMEA)Apply statistical methods and process / design excellence tools, in order to establish test plans and evaluate test data and processes.
Perform Gage R&R studiesSupport the definition and the clarification of MDR supplier requirements related process Being a cross-departmental communicator of MDR and Quality, among the Product Development, Regulatory Affairs, Manufacturing, and Marketing divisionsYour profileBachelor’s degree in Engineering or technical / scientific related field More than 7 years of experience in a quality engineering role within the medical device and / or pharmaceutical industry Strong background in Medical Device Regulatory Compliance and AffairsProfound knowledge of Design Controls, GMPs, QSR, 21 CFR 820, MDD 93 / 42 / EEC, ISO13485 and ISO14971 quality requirements Skilled in Quality Engineering, as well as in design process verification / validation, in addition to design / process Failure Mode and Effects AnalysisExperienced in Development and Manufacturing, with knowledge of material science and mechanical productsSkilled in Microsoft OfficeFluency in English is required.
German knowledge will work as an assetIf your profile matches the requirements of the position, we will contact you within the next fifteen (15) days of submitting your application.
Otherwise, please kindly consider that your application is unsuccessful. Please note, that we only accept applicants with Swiss or EU / EFTA citizenship or applicants with an existing and valid residence and work permit for Switzerland.
Altran is an EEO and Affirmative Action Employer of Females / Minorities / Individuals with Disabilities. Job TitleMDR / Quality EngineerVacancy Reference Number22987Work SiteSwitzerland / CHE - All Regions / Basel Contract TypePermanent Full-Time Minimum number of years of experience required5 years of experience and more