Responsibilities Represent Quality in cross-functional projects, ensuring compliance with regulatory and internal quality standards. Participate in the execution of quality functions in compliance with FDA QSR, ISO 13485, and ISO 4971, and other national and international standards. Support process verification and validation activities (IQ/OQ/PQ), including documentation and reporting. Collaborate in the development and update of manufacturing documentation, including procedures, work instructions, and risk management (e.g., FMEA). Analyze manufacturing issues and non-conformities to identify root causes and drive continuous improvement actions. Support supplier quality activities (audits, validations, changes) and participate in internal and external audits. Qualifications Fluent in English (bilingual). 5–10 years of experience in the medical manufacturing industry as a quality engineer. Bachelor’s degree in engineering. Knowledge of ISO 13485 and ISO 14971. Knowledge of statistical techniques. Proficient in Excel, databases, and word processing software. Experience in Lean Manufacturing (Kaizen, Continuous Improvement, Standard Work, Kanban, 5S, SMED, VSM, Poka-Yoke). #J-18808-Ljbffr
Senior Quality Engineer (Medical Manufacturing )
OFERTA CONFIDENCIAL
tijuana, tijuana
Publicado hace 26 días
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