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    Quality Engineer II - Corona, United States - Agili

    Agili
    Agili Corona, United States

    3 weeks ago

    Default job background
    Upper Management / Consulting
    Description

    The Quality Engineer II will utilize and maintain quality engineering systems and practices in collaboration with Agiliti manufacturing and design centers that meet and exceed internal, customer, and regulatory requirements.

    PRIMARY DUTIES AND RESPONSIBILITIES

    • Perform quality engineering tasks for new & existing products and process development and improvement initiatives.
    • Applies systematic problem-solving and SPC methodologies in identifying, prioritizing, communicating, and resolving quality issues.
    • Develops and maintains product control plans, models and inspection methods for raw materials, materials in process, and final release.
    • Collaborates with Design, Manufacturing, and Supply Chain teams to monitor supplier performance.
    • Monitor and analyze supplier performance data, detecting trends, and collaboratively addressing any deviations or issues with suppliers.
    • Collaborates in planning, execution, and maintenance of equipment validation activities. (IQ, OP and PQ)
    • Participates in and may lead plant Material Review Boards (MRB) to assist with investigations and disposition of product nonconformances.
    • Lead review activities to maintain medical device files, resulting from engineering change orders, such as Risk Management, Process FMEA, and Quality Control Plans.
    • Participates in execution of verification and validation protocols.
    • Participates in projects and cross functional teams. May lead mid-scale projects.
    • Lead CAPA investigations and action item implementation.

    EXPERIENCE

    • Bachelor's Degree (BS) in Engineering, Scientific, or Technical related subject required.
    • 3-7 yrs. of relevant experience, preferably in an ISO regulated manufacturing environment.
    • Experience in Design Controls Management (Design & Development Planning, Design Input, Design Output, Design Review, Design Verification & Validation, Design Transfer, Design Changes, and Design History File).
    • Experience in FDA 21 CFR Part 820 Quality System Regulation preferred.
    • Experience in ISO 13485:2016 Medical Devices, preferred.
    • Experience in ISO14971 Risk Management preferred, but not required.
    • Experience with metrology equipment and lab preferred, but not required.
    • Experience with working and qualifying automation equipment.
    • Use of statistical analysis software for SPC & CPk Analysis
    • Tooling and fixturing qualification experience (FAI and Gage R&R)

    SKILLS & ABILITIES

    • Electrical engineering background preferred.
    • Bilingual in Spanish is a plus.
    • Proficient computer skills in MS Office Suite, including MS Project and Visio.
    • Working knowledge of CAD software preferred (i.e., SolidWorks, Autodesk, etc.)
    • Strong analytical skills and attention to detail
    • Strong technical writing skills and effective communication skills
    • Strong presentation, facilitation, and project management skills
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