Quality Engineer 1 page is loaded## Quality Engineer 1remote type: Onsitelocations: Reynosa, TAMPS, MEXtime type: Full timeposted on: Posted Todaytime left to apply: End Date: November 21, 2025 (30+ days left to apply)job requisition id: R0221286**Quality Engineer****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.**#1 Top Workplace in the area.**
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📌 Quality Engineer 1
🏢 Ch01 Che Fresenius Medical Care (Schweiz
📍 Reynosa