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    Senior Quality Engineer - Beverly, United States - William H Hunter Recruiting

    William H Hunter Recruiting
    William H Hunter Recruiting Beverly, United States

    2 weeks ago

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    Description
    Job Description

    Job Description

    Summary/Objective

    The primary responsibilities include assisting in examination and approval of components and finished products.

    Utilizing different tools and techniques, the Quality Engineer will help ensure that only the highest quality products are delivered to our customers.

    Essential Functions


    Conducts and supports investigations of manufacturing nonconformities; recommends, develops and implements effective corrective actions


    Coordinates, collects, analyzes and distributes quality monthly and quarterly metrics


    Participates in audits conducted by regulatory agencies and/or customers


    Participates in supplier evaluation and selection assessments


    Ensures appropriate compliance and operational effectiveness in all areas of the QMS including document control, change control, training, complaint handling, CAPA, nonconforming process and auditing (internal and external)


    Works in collaboration with Product Development to ensure that the designs, procedures and outcomes of the project are acceptable in quality.


    Proficient with Microsoft Word, Excel & PowerPoint

    Competencies


    Experience with ISO 13485 certification and FDA's 21CFR 820 preferred


    Demonstrated experience with mechanical measurements and understanding of GD&T required


    Experience in a Good Manufacturing Practice (GMP) environment is required


    Extensive experience writing and implementing policies, processes and procedures is required


    ASQ certified Quality Auditor and/or Quality Engineer is preferred but not required


    CQE, CRE, PE, CRA Certifications are highly desirable


    Lean Six Sigma Green or Black Belt required


    LIMS and ISO 17025 experience is a plus

    Requirements


    • Bachelor's Degree.
    2. 5 or more years of Manufacturing Quality Engineering experience.
    3. 5 or more years of ISO experience.

    William H Hunter Recruiting

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