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    Principal Quality Engineer - Irvine, United States - Meet

    Meet
    Meet Irvine, United States

    6 days ago

    Default job background
    Upper Management / Consulting
    Description

    Key Responsibilities:

    • Oversee the effectiveness of the design control process, ensuring compliance with regulatory requirements and meeting customer expectations.
    • Collaborate with Development and Engineering teams to ensure adherence to design control requirements, encompassing design verification, validation, risk management, and design review.
    • Provide input on Design History File (DHF) deliverables, including material specifications, drawings, and manufacturing procedures, to ensure product manufacturability and testing adequacy.
    • Review and approve design control-related Change Notices (CNs) within the documentation system.
    • Develop and enhance processes to ensure consistent compliance with internal requirements and external regulations and standards.
    • Represent the design quality functions in reviewing and approving designated design outputs.
    • Serve as a subject matter expert in design control processes and Quality Engineering, including Risk Management, Test Method Validation (TMV), Statistics, Reliability Engineering, and Process Validation (PV).
    • Support the quality management system as needed.

    Requirements:

    • Bachelor's degree in Engineering with at least 8 years of relevant experience, or an equivalent combination of education and experience.
    • Prior experience in medical device development control is essential.
    • Proficient understanding and practical application of 21 CFR Part 820, ISO 13485, and ISO 14971 standards.
    • Experience in process validation, including IQ/OQ/PQ, is a plus.
    • Excellent communication skills with the ability to convey ideas clearly and concisely.
    • Strong attention to detail, organizational skills, and ability to prioritize tasks effectively.

    Education:

    • Bachelor's degree in Engineering or a related technical discipline.
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