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    LEAD QE Consultant - New York, United States - Insight Global

    Insight Global
    Insight Global New York, United States

    3 weeks ago

    Insight Global background
    Description
    Job Description

    Preparation of HW engineering technical documentation (Desing History File) for medical device including accessories for clinical trials and FDA 510K Submission

    Establish Verification & Validation testing plan/protocol in cooperation with Engineers based on existing development data

    Coordinate with Product development teams to create development documents that reflect Product Requirements

    As a Project Manager, Cooperation with necessary personnel and departments and project management in creating DHF


    We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day.

    We are an equal opportunity/affirmative action employer that believes everyone matters.

    Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances.

    If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to .

    To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy:
    .

    Skills and Requirements

    Experience in taking the lead in writing technical documents, FDA 510K submission

    Strong understanding of relevant regulatory requirements (21 CFR 820.30, ISO 13485 Design and Development, etc.)

    Minimum 5+ years' experience in a regulated product development/systems environment

    Working experience with the following standards: IEC , IEC , ISO 14971, ISO 13485

    Bachelor's degree in Electronics, Mechanical engineering

    Able to work during Korean working hours

    Preferred Qualifications Experienced in RF and EMC testing and troubleshooting

    Experience in optical devices development/RA

    Able to communicate in Korean null


    We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day.

    We are an equal employment opportunity/affirmative action employer that believes everyone matters.

    Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances.

    If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to
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