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    Senior Quality Engineer - Billerica, United States - Lumicity

    Lumicity
    Lumicity Billerica, United States

    2 weeks ago

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    Description


    My client is driven by a singular purpose: to transform the landscape of healthcare through groundbreaking innovations in medical device diagnostics.

    As a premier leader in the MedTech industry, they harness cutting-edge technology and unwavering commitment to usher in a new era of precision diagnostics.


    Duties:


    Fulfill responsibilities in sustaining engineering through operational quality tasks – including material oversight, process enhancement, inspection/validation procedures, management of noncompliant materials, equipment validation, and oversight of suppliers.

    Engage in risk management activities - involving analysis and documentation implemented across the product development continuum.
    Examine and verify materials, machinery, processes, and final products to ensure adherence to quality standards.
    Assist in the development and validation of testing methods.

    Assist design engineering teams in the oversight of catheter, hardware, and system development within the framework of design control procedures.

    Devise and execute processes within the quality system to align with regulatory protocols.

    Requirements:
    Bachelor's degree in mechanical engineering, biomedical engineering, or a relevant engineering discipline.
    3-5 years of experience in quality engineering, quality assurance, or a comparable capacity within a regulated sector.
    Background in catheter, hardware, and system production, or analogous medical devices, operating within a Quality Management System.
    Proficient knowledge of 21 CFR 820 and ISO 13485:2016.
    Demonstrated proficiency in Process Validation, Product Validation, and Statistical Methods.
    Experience with risk management and design control procedures.

    Strong verbal and written communication skills, adept at formal documentation (protocols, reports), meticulous attention to detail, and proficient project management abilities.

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