.Quality Engineer I***:**You see the trees and the forest**:**What some may consider a small oversight can cause a major work problem. That's why we need a keen observer like you who notes the out-of-place crack before it spreads into a disastrous gap. You have a meticulous work ethic, founded on attention to every element of a situation. We hold your skills in high esteem and can't wait to hear from you.***:**Collaboration brings out the best in us**:**The shared celebratory moment when your team has nailed that solution, the mutual respect, the ability to compromise, these are rewards of our collaborative environment — plus, of course —the personal growth and smarter solutions group effort produces. We value our diverse staff for the skills and stimulating perspectives that make our collaborations so successful. Join us.***:**Participation in the change control committee and in the evaluation of suppliers****Management, monitoring, and evaluation of customer complaints.***:- ** Coordinate the development of validation protocols for new and existing equipment through the use of approved procedures to ensure their quality.**:- ** Continue with the best practices and safety guidelines in the area, in order to achieve KC's objectives.**:- ** Participate in planned inspections and accident incident investigations for the SMART system.**:- ** Follow the requirements of the environmental policy.**:- ** Assist the manager of the Quality department in the planning, and organization of the activities and work carried out in the quality department, such as the systems put into practice and maintaining the standards according to the FDA and the GMP, for quality and conformation of the product.**:- ** Contributing to ensuring the maintenance of the required certifications, and ensuring the availability of the product in the global market. This includes ISO 9000 and 46002.**:- ** Review, verify and develop test methods for products and/or processes through the use of applicable procedures to ensure that they meet the established requirements.**:- ** Manage, execute and control the calibration and test equipment based on the requirements to ensure that the tests are performed with reliable measurements based on the standards.**:- ** Generate the necessary statistics to be able to monitor the non-conforming product, the DPM of receipt, process, and packaging with trends that allow us to determine its capacity.**:- ** Ensure compliance with the requirements of quality standards and regulations (ISO-13485, FDA / GMP), according to policies and procedures already established.**:- ** Routinely audit compliance with the specified requirements (Including System, Product, and Process Audits).**:- ** Carry out investigations and corrective actions in response to customer complaints.**:- ** Evaluation and/or validation of software