**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. + Knowledge of sampling distributions, Binomial, Poisson, Normal and Exponential distributions and be able to apply statistical inference in each. + 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. + Apply and incorporate risk management techniques throughout the product life cycle. + 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. + 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.