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    Software Quality Engineer III - Santa Clarita, United States - TotalMed, Inc.

    TotalMed, Inc.
    TotalMed, Inc. Santa Clarita, United States

    1 month ago

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    Description

    Software Quality Engineer III

    Location: Valencia, CA

    Shift: M-F / 8am-4:30pm

    Pay: $67.00 /hour

    Experience Requirements

    • BS degree in Computer Science or Software/Electrical Engineering
    • 5-8 years with BS degree, 3-6 years with MS degree, 0-3 years with PhD
    • Minimum of 3 years of Software testing in commercial products
    • Working knowledge of testing process and methodologies
    • Manual testing and documentation experience in a regulated environment
    • Understanding of Software Development Life Cycle Processes per IEC 62304
    • Some experience in Programming Languages such as C#, C++, Swift, Java/JavaScript, Cloud, Windows, iOS, Android, Python, LabView

    Preferred qualifications:

    • MS degree in Computer Science or Software/Electrical Engineering
    • Must possess excellent organizational, clear verbal and written communication skills
    • Must be team-oriented with people skills and positive attitude
    • Must be detail oriented and passionate about building quality into products
    • Experience working in highly regulated environments
    • Basic academic knowledge of principles of Neuromodulation
    • Experience with CAPA, Complaint Handling, and External Audit
    • Experience/Understanding of Risk Management as per ISO 14971
    • Understand Premarket and Post Market Cybersecurity Guidance
    • Understand Bluetooth technology and Mobile applications development
    • Understand aspects of HIPAA and GDPR compliance practices
    • ASQ Certified Quality Engineer (CQE) or ASQ Certified Software Quality Engineer (CSQE)

    Job Description

    • Actively working within a team of Product Software Quality Assurance Engineers
    • Contributing to all aspects of Software/Firmware Quality Assurance activities
    • Ensuring quality of software systems, validating product software and firmware requirements
    • Overseeing design, development, and test of software related to client Neuromodulation product lines
    • Creation and execution of Design Validation Plan, Protocols, and Reports
    • Reviewing design, development, and testing of software and firmware for Neuromodulation products
    • Supporting Automated Test Equipment validation activities
    • Participating in various validation activities including User Needs Requirements, Cybersecurity, Usability, and Risk Management assessments

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