Ag-Ingeniero De Calidad Jr

Job ResponsibilitiesEnsure compliance and maintenance of the Quality Management System (QMS).Support internal and external quality system audits, ensuring compliance.Lead investigations, manage non-conformances (NC), and perform CAPA review and approval tasks.Train new employees on AG's procedures regarding quality management systems.Plan and execute internal audits based on the processes of the organization.Coordinate and provide applicable compliance training.Interpret and apply regulations such as FDA, ISO, MDSAP, EU MDR, and AG policies.Support trend analysis on key performance indicators and organize Management Reviews.Minimum QualificationsBS in a science, engineering, or related discipline.0 - 2 years of similar experience in a highly regulated industry.Experience with the following regulations/standards preferred: 21 CFR Part 820, MDSAP, ISO standards (e.G., ISO 13485:2016, ISO 14971:2019).Knowledge of manufacturing processes, statistical techniques, environmental controls, and basic regulatory requirements for medical devices is preferred.Knowledge of quality management system processes (NC/CAPA, Complaints Handling, Management Review, etc.) is preferred.Bilingual (English & Spanish).Utilize proper software to maintain project records, including MS Office, SharePoint, Visio, and/or Power BI.#J-18808-Ljbffr