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    Sr. QA Software Engineer - Irvine, United States - Prismatik

    Prismatik
    Prismatik Irvine, United States

    2 weeks ago

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    Description

    Job Description

    Key Responsibilities:

    • Offering expertise and guidance in interpreting policies, regulations, and internal rules to ensure compliance.
    • Collaborating with software development teams on Software Development Lifecycle (SDLC) documentation, such as development plans, verification and validation, requirements specifications, architecture and design documents, and code reviews.
    • Participation in Quality Management System (QMS) activities following US FDA Quality System Regulations and ISO standards.
    • Engaging in software risk management, including cybersecurity risks, by providing input to development teams.
    • Staying informed on both existing and new regulations to uphold compliance of current software.
    • Using knowledge and expertise to assist the development team in finding solutions to meet regulatory requirements.
    • Performing testing to evaluate the effectiveness and accuracy of software against operational standards.

    Minimum Qualifications:

    • Bachelor's degree in Computer Science, Software Engineering, Informatics, Biomedical, or related field, or equivalent education and experience demonstrating comparable skills and capabilities.
    • At least eight (8) years of software engineering experience in FDA QSR/ISO 13485 within the medical device sector.
    • Proficiency in applying IEC Medical Device Software Lifecycle Processes, ISO Risk Management, Medical Electric Equipment standards, and Usability Engineering.
    • Experience with Agile methodologies like Scrum and Kanban, as well as non-embedded software development areas such as web development.
    • Previous exposure to cloud-based software is a plus.
    Pay range: $100,000-$130,000 per year. Actual compensation may vary depending on individual skills and background.
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