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    Quality Engineer 3 - Washington, United States - Open Systems Inc

    Open Systems Inc
    Open Systems Inc Washington, United States

    1 week ago

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    Description

    Job Description

    Job DescriptionQuality Engineer 36 Months Contract Washington, DC 20004Description:

    Position Description:

    Remote opportunity for a Medical Device Risk Manager that will be leading a Risk Management Team focused on remediating existing Risk Management Files for the Digital Oncology portfolio.

    We are looking for candidates in Central and Eastern time zones.

    Summary:

    Leads Risk Management efforts and processes for the Varian software Product portfolio, with a main focus on Varian's Digital Oncology Information system (OIS) software products.

    Remediate existing clinical software Risk Management Files that include risk management plans, hazard analyses, risk assessments and post market surveillance.

    Collaborates as risk management file owner with healthcare software development teams to ensure the comprehensive implementation of risk control measures in the clinical software in accordance with Varian's risk management procedure and international standard ISO 14971Minimum Required Skills and Knowledge:
    Bachelor's degree in Healthcare, Science or Engineering with several years of related experience. At least 5 years of relevant experience in medical device risk management or digital electronic health record system. At least 5 years of relevant experience in Healthcare Software Development.

    Knowledge in ISO 13485, ISO 14971, FDA CFR 820, EU 2017/745, IEC 62304, IEC 82304 and IEC/TR Medical Device Risk analysis, risk control measure evaluation, implementation and validation testing experience.

    Good written and verbal communication in English language. Strong interpersonal skills Knowledge and understanding of international safety standards for medical devices. Related experience with US Class II or III (EU class IIb or III) medical devices is highly desired. Related experience with Software as a Medical Device (SaMD), Risk analysis and Cybersecurity Risk management.

    Proficient in utilizing business tools such as:
    Outlook, Microsoft Office.
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