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*quality engineer i*responsibilities*:- completes projects as assigned by the department manager.
must be able to prioritize responsibilities and establish time lines in order to maintain a balance of support in all projects and execute projects with clear objectives.
communicates project deliverables, objectives, and timelines to team members.- utilize established procedures to perform routine assigned tasks under close supervision.- support the evaluation of customer complaints along with the development of corrective/preventive actions/corrections (capa/nc).- monitor internal nonconformance (nc) and assist developing corrective and preventive actions as part of the quality team.- responsible for making regular walkthroughs throughout the manufacturing area in order to develop and/or participate in projects for process improvement and the overall quality of the product.- responsible for the development and implementation of test methods for medical devices and equipment.- assist the different departments in validations of product, processes as well as on the writing of the validation protocol when needed.- analyze data with statistical software and quality tools such as risk analysis, flow charts, control charts, scatter diagrams and histograms.- conducts correlation and regression analysis, experimental design (doe) and acceptance sampling; as well as conducting and interpreting gage r&r studies.- ensure regulatory compliance to cgmp's of all medical device regulatory agencies (i. e fda, iso and mdd) providing proper documentation corporate regulatory on evaluation and analysis on customer complaint samples as well as fir's when required.- participate in conference calls, presentation and meetings with internal departments, cross site teams and upper management when required.- maintain constant communication with corporate qe/pss, canada or other fmc sites in relation to capas, overall quality improvement projects and customer complaints when required.- this position will be required to support and respond to internal/external audit observations and corrective actions.- support new design transfer activities, engineering changes and savings projects.- initiate and participate in change control activities.
*qualifications*:- bachelor's degree required, preferably in mechanical, industrial, electrical, electromechanical, biomedical or any other equivalent engineering degree.- two years of experience in quality engineering or related field (medical devices preferred).- excellent interpersonal, verbal and written communication skills.- must have good technical and analytical skills.- ability to understand and employ mathematics at an engineering or scientific level.- strong computer skills.- ability to effectively present information to upper management and other groups.- problem solving and root cause analysis.- knowledge of six sigma methodology