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    Quality Engineer - Acton, United States - Insulet Corporation

    Insulet Corporation
    Insulet Corporation Acton, United States

    2 weeks ago

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    Description


    Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod product platform.

    In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.

    We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations.

    Our continued success depends on itJob Title:

    Quality Engineer IDepartment:
    QualityFLSA Status: Exempt

    Position Overview:

    This position is responsible for providing Quality Engineering support for commercially manufactured product, as well as working closely with Insulet's suppliers to ensure product quality.

    The role provides insight and guidance to Insulet's Quality Operation processes including non-conformances, corrective and preventive actions, Process Change Order Assessment (PCOA) and resolution of manufacturing quality related issues.


    Responsibilities:

    Maintain company compliance of FDA Quality System Regulations, ISO 13485, and other applicable standards/regulationsWork with Manufacturing and the contract manufacturer to resolve issues that involve quality gaps and production nonconformance'sWork with suppliers to ensure timely response and appropriate investigations for supplier product quality issuesConduct failure investigations, root-cause analysis, and corrective action implementation.

    Develop and document Quality processes, procedures, work instructions, and/or formsDevelop and execute test method validations and equipment qualificationsDevelop/Modify Incoming Quality Assurance sampling plansProvide Quality Engineering support and expertise to Manufacturing, Engineering, Marketing and other company functions, as it relates to Supplier QualityReview and approve protocols/reports for validation activitiesMaterial qualification and material acceptance ownershipPerform other duties as assignedEducation and Experience:

    Minimum Requirements:
    BS degree in engineering, a technical or scientific discipline; and/or equivalent combination of education and experienceExperience with FDA and ISO 13485 inspections preferredPreferred Skills/Competencies: Minimum of 1 year in a Quality Engineering function working with QSR and ISO 13485 preferredEffective verbal and excellent technical writing skillsAbility to communicate and work effectively at multiple levels within the organizationAbility to organize and judge prioritiesExcels at generating and maintaining organized and accurate recordsPC skill, word processing, spreadsheet, database


    NOTE:
    This position requires on-site working (requires on-site office/plant/lab work)

    #LI-Onsite Additional Information:


    The US base salary range for this full-time position is $65, $98, Our salary ranges are determined by role, level, and location.

    The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US.

    Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training.

    Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process.

    Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.

    At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

    (Know Your Rights)
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