Quality Engineer

hace 3 semanas


Xico, México Ametek A tiempo completo

This is a professional position with responsibilities for elements of the quality program.The Quality Engineer ensures product and process quality throughout the manufacturing cycle, with a strong focus on ISO compliance, incoming material inspections, equipment validation and continuous improvement.This role supports internal audits, root cause analysis and the implementation of corrective and preventive actions.The engineer works closely with cross-functional teams to maintain high standards of quality and productivity and serves as a technical reference and subject matter expert for colleagues with less experience.ResponsibilitiesApply and enforce ISO quality standards across manufacturing processes, incoming materials, and final inspections.Conduct and document First Article Inspections (FAI) and ensure compliance with customer and internal specifications.Perform part inspection, including layout, in-process, final and receiving inspections, using all types of mechanical inspection.Conduct equipment validation using IQ/OQ/PQ methodology by writing and developing protocol validations.Develop and maintain work instructions, quality procedures, and inspection documentation.Support translation of documents from English to Spanish.Lead and support internal audits and assist in external audit readiness.Perform root cause analysis and implement corrective / preventive actions (CAPA).Monitor and improve key quality metrics such as yield, scrap and customer returns.Support Engineering Change Orders (ECOs) and product validation processes.Support engineering and purchasing with historical supplier performance data for evaluation / selection of new products.Collaborate with production, engineering and supply-chain teams to resolve quality issues.Maintain calibration systems for measurement and test equipment.Utilize ERP systems (AS400 / INFOR) for quality documentation and inventory control.Education & ExperienceEducation: Bachelor's degree in industrial engineering, electronics, electrical or mechatronic engineering.Knowledge of medical device regulations / standards, including 21 CFR 820 (QSR) and ISO.Experience: Minimum 1 year in a quality role within an electronics / medical manufacturing environment.Experience working in a Class I and Class II Medical Device environment.Experience with incoming material inspection, FAI and shipping quality control.Background: Proficient in Microsoft Office (Excel, Word, PowerPoint); experience with ERP systems (AS400 / INFOR preferable).English proficiency and ability to travel to the U.S. if required.CompetenciesCritical thinker with good troubleshooting skills.Able to manage several projects concurrently and show results.#J-*****-Ljbffr


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