Senior Design Assurance Quality EngineerLocation: GalwayDuration: 12 month contractNon negotiables:Requires a Bachelors degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.Ability to identify root causes and implement corrective actions.Strong technical writing ability and strategic/ critical thinking ability.Fluent written and spoken English.My client are a medical device organisation based in Galway looking to hire a Senior Quality Engineer to join their team on a 12 month contract basis. Ideally you will have your own Ltd Company but arrangements can be made once you are open to contract roles.ResponsibilitiesSupport sustaining commercial projects from a Design Assurance perspective. You will be directly involved in making sure products are maintained through the full product lifecycle and that these products comply with global standards.Support the introduction/implementation of product/process/materials changes to the manufacturing operation. You will assess the patient risk appropriately for these design changes. You will provide QA technical direction/input to qualification and validation activities in conjunction with R&D and Mfg. Engineering.Responsible for generation of Design Verification protocols & will participate in the compilation of design verification and shelf life data for regulatory submissions to support design change approval.Interface with Regulatory Affairs to ensure information is clearly presented to minimise Regulatory Agency questions.Contribute to establishing strong working cross functional relationships across the organisation and with partners within a complex technical environment.As part of ongoing professional development, you will maintain expert, up to date knowledge of developments in regulatory compliance requirements for product design, development, and commercialisation activities. You will generate and approve change requests.Lead investigation analysis and timely completion of same.Collaborates with engineering and manufacturing functions to ensure quality standards are in place.Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specificationsEnsures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.May specialise in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.RequirementsExperience applying Statistical AnalysisDesign Verification experienceDynamic team player who can work effectively and proactively on cross-functional teamsGood communicator and fluent in English, both in writing and speaking.Initiates and Leads Change, Collaborates and Creates Alignment, Drives Accountability and Thinks Critically and Makes Sound Decisions.Provide input to design and manufacturing deliverables including material specifications, drawings, inspection procedures, and manufacturing proceduresFor more information, contact Alan on alan@accpro.ie
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