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    • Junior Validation Engineer - Tijuana, B.C. - ICU Medical

    ICU Medical
    ICU Medical Tijuana, B.C.

    hace 2 semanas

    Default job background
    Descripción

    Job Summary

    Ensure that company operations comply with all applicable laws, regulations, standards, and good business practices, as well as documented procedures. This includes knowledge of governmental health, occupational, and environmental standards, regulations, and statutes related to the site.

    Key Responsibilities

    • Develop and maintain validations (IQ, OQ, and PQ) for all SHM processes and equipment.
    • Achieve specific objectives and goals according to assigned areas.
    • Identify and execute projects to improve processes and reduce product cost.
    • Use specialized manufacturing tools (pFMEA, SPC, Lean Manufacturing, Six Sigma) to resolve issues related to the area.
    • Document and improve manufacturing processes to meet requirements (Cpk, Gage R&R, T-Test).
    • Lead interdisciplinary teams to achieve project objectives and resolve chronic problems.
    • Complete activities on time to ensure compliance with Engineering and Plant department goals.
    • Procure, design, and validate safe process tools and equipment to reduce losses based on QRS and ISO 13485 requirements.

    Minimum Qualifications, Education, and Experience

    • Bachelor's degree in engineering or similar field (4 years). 2-5 years of experience or 1-2 years with a postgraduate degree.
    • Medical Device manufacturing experience (1-3 years).
    • Fluent Spanish/English communication skills (verbal and written).
    • Strong understanding and application of technical principles, theories, and concepts in engineering. General knowledge of disciplines (GPM, GQR, sales, and operations).
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