Engineer Principal Quality – Nogales Overview Principal Quality Engineer responsible for ensuring quality and compliance of medical products across manufacturing processes. Responsibilities Coordinate development of validation protocols for new and existing equipment using approved procedures. Assist the Quality manager in planning, organizing activities, and work within the quality department, ensuring systems and standards are maintained in accordance with FDA, GMP, ISO 13485, and 21CFR Part820. Ensure maintenance of required certifications and product availability in the global market. Coordinate, review, and apply methods of material and process inspection through approved procedures to maintain quality at all manufacturing stages. Manage, receive, and control customer complaints via the established claims system to maintain timely responses. Analyze process trends, conduct investigations, and use PPM to measure process capacity. Apply industrial engineering principles to process management, machinery calibration, change analysis, and validation. Implement sampling systems in process inspection methods and meet all security requirements across processes. Required Qualifications Engineering background (Quality Engineering preferred). At least 6years of experience in Quality within a manufacturing environment. Proven experience in medical industry manufacturing processes. Solid knowledge of process and product quality (in‑process and final product). Strong background in process validation (acting as technical reference and tutor). Experience supporting internal and external audits. Ability to lead and influence teams, including direct and indirect leadership (M1 level). Advanced professional English communication skills. Preferred Qualifications Experience with FDA regulations for medical products. Lean / Six‑Sigma certification (Green Belt or higher). Experience working across multiple manufacturing platforms or production areas. Equal Opportunity Employment Statement Kimberly‑Clark is a committed equal‑opportunity employer; all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity, age, pregnancy, genetic information, citizenship status, or any other characteristic protected by law. The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. They are not an exhaustive list of duties, responsibilities, and skills required for this position, and employment is subject to verification of local policies. #J-18808-Ljbffr