.We are growing and expanding our Manufacturing Site in Mexico! In the job as Quality System Engineer, you will have the opportunity to actively support the organization by ensuring that our manufacturing site runs as needed to have the growth expected of the products we make in Mexico, excel in your own daily tasks and responsibilities, and experience a very varied working day in a dynamic environment.Objective:The Quality System Engineer is responsible for performing quality systems duties, including maintenance of corrective action and preventive action (CAPA), Nonconformance process, planned deviation process among others. Ensures and maintains a state of inspection readiness. Performs in various quality functional areas and maintains expertise.Duties/Responsibilities:Ensures compliance of the Corrective Action and Preventative Action (CAPA), NCR, and Planned Deviation processes.Serves as site trainer for the Corrective Action and Preventative Action (CAPA) and Nonconformances systems and Planned Deviation process.Provide coaching and guide teams to follow QMS processes.Leads quality projects with cross-functional teams.Maintains quality records on product testing, nonconformance, project outcomes, and stakeholder input filed in an accurate and timely manner.Makes proposals and assists in the development of corrective and preventative action plans and monitors implementation.Facilitates and works with CAPA owners to support the identification of issues, investigations, root cause analysis, action plan development and completion, and verification of the effectiveness.Facilitates the tracking and closure of corporate Nonconformances (NCs) to ensure consistency in compliance in areas of evaluation, risk, corrections, timeliness, quality, and thoroughness of content.Facilitates quality metrics gathering, analyzing, and reporting on a regular basis.Supports the development and rollout of standardized QMS data sources and metrics across all levels of the organization of key quality system processes (i.E., Management Review, Corrective and Preventative Actions, monitoring meetings, etc.)Conducts investigations, collects data, analyzes trends and prepares reports for assigned quality processes.Assesses current quality systems and recommends improvements in order to enhance quality and reduce cycle time.Monitors trends, identifies issues, recommends, and implements appropriate actions.Assists in the development, implementation, and review of standard operating procedures.Maintains current knowledge of the regulations and ISO 13485.Has thorough understanding of process criteria and regulations and business impact of decisions and actions.Knows and follows all laws and policies that apply to one's job, and maintains the highest levels of professionalism, ethics, and compliance always.Conducts internal audits as needed and supports external audit