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    Sr. Software Quality Engineer - Tulsa, United States - Insight Global

    Insight Global
    Insight Global Tulsa, United States

    3 weeks ago

    Insight Global background
    Description
    A client in the Medical Device industry is seeking a Sr.

    Software Quality Assurance Engineer to support the full product development life cycle for their commercial implantable pain management device group.

    The role will entail development, testing, and validation of software + firmware products within a highly regulated medical device environment.

    This resource will be responsible for maintaining quality standards of their software systems, validating firmware requirements, and adhering to security compliance requirements throughout the product life cycle from requirements gathering through retirement phases.

    The ideal candidate will be comfortable creating and executing Design Validation Plans, Protocols, and Reports for system level testing and be detailed regarding documentation of user requirements, hazard analysis, risk assessment, etc.

    This resource will be joining a team of Product Quality Engineers helping support validation activities encompassing User Needs Requirements, Design Requirements, Functional, Architectural, Module Design Details, Code and Design reviews, Unit tests, Integration tests, System level (black box), Structural (white box), Test Automation, Ad-Hoc/Exploratory test activities, Cybersecurity, Usability, and Risk Management, Design FMEAs, and Hazard Analysis.

    This role is hybrid, onsite 3 days a week in Valencia, CA.


    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:


    .
    Nice to Have Skills & Experience

    Medical Device, Highly Regulated Industry, or Neuromodulation/Implantable device experience.
    Experience with CAPA, Compliant Handling and External Audit, Risk Management (ISO14971), Pre/Post Market Cybersecurity.
    Experience with Mobile Application development or Bluetooth technology
    Understanding of HIPAA and GDPR Compliance
    ASQ Certified Quality Engineer (CQE) or ASQ Certified Software Quality Engineer (CSQE) certs.

    Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching.

    Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.

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