Quality Engineer 1

hace 3 semanas


Reynosa, México Fresenius Medical Care A tiempo completo

**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.- 0-2 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.- Responsible of providing the necessary engineering support and developing process/product/quality improvements and controls to assure a high confidence on the final finished product.- Ability to develop and implement new methods as well as the usage of statistical tools to solve quality problems and detect process behaviors.- Should practice a customer-focused quality approach.- Perform process capability studies.- Bilingual English / Spanish.- U.S.A Visa required.


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