PROJECT QUALITY ENGINEER

Description

Position Summary: Quality Engineer responsible for participating in project transfers, new product introductions, updating quality documentation, and coordinating related activities. Key Highlights: 1. Active participation in technology transfer and NPI projects. 2. Updating key quality documents such as FMA's and DHF's. 3. Coordination and decision-making in quality projects. Description and Details of Responsibilities * Actively participate in project review meetings for inter-facility technology transfer and new product introduction (NPI) projects. * Update quality documents such as FMA's, DHF's, and DMR documents to support the creation of new manufacturing processes. * Develop and execute Measurement Technique validations and/or coordinate support to complete them. * Participate in Design Review meetings related to Test Techniques and/or quality documentation. * Ensure compliance with the Quality System for Design Control and Process Transfer (Design Control SP-331 and Process Design Transfer SP-445). * Perform all other duties that naturally arise from operational requirements and/or are assigned or requested by the immediate supervisor. * Organize internal project review meetings within the Quality Department. * Fully manage and coordinate quality involvement and activities in related projects. * Serve as a support resource for departments in making decisions related to the designated manufacturing area. * May organize and track activities to be executed between themselves and other Quality Engineers. * Make decisions and participate in defining strategies to complete internal or transfer projects. Experience and Requirements * Advanced computer skills, ability to read drawings and specifications. * Knowledge of ISO 13485, CFR, and/or QSR. * Product knowledge and training in the quality management system. * Knowledge and experience in Product and Process Design Control activities. * Technical knowledge of common manufacturing processes, e.g., (but not limited to) injection molding, plastic extrusion, corrugators, ultrasonic sealing, radiofrequency (RF) sealing, etc. * Intermediate-to-advanced proficiency in MINITAB. * Internship or degree and/or equivalent experience in Industrial Engineering or related field. * 0–2 years of experience in a similar position. * Intermediate English proficiency (spoken, reading, and writing). * Knowledge of ISO 14001 (current version) and identification of environmental aspects and impacts. * Regulations: QSR (21 CFR Part 820), ISO-13485, NOM-241 Benefits * Benefits per Mexican Federal Labor Law (LFT) * Savings Fund * On-site medical services * Cafeteria * Funeral expenses coverage * Motivational events * Monthly Health Program * Life insurance **Number of vacancies** 1 **Department** Quality **Employment type** Permanent **Work modality** In-person **Shift** Day shift **Working hours** Full-time **Schedule*** Full-time * Monday to Friday **Education** Bachelor's degree with professional title **English** Spoken: Intermediate, Written: Intermediate **Willingness to travel** No