Quality Software Engineer Ii - Burlington - Groe Advisors, LLC

    Groe Advisors, LLC
    Groe Advisors, LLC Burlington

    14 hours ago

    Description

    We are seeking a highly skilled Quality Software Engineer II, specialized in GxP systems, to join our team and ensure that our software solutions for medical devices and pharmaceutical products adhere to the highest quality and regulatory standards.


    Responsibilities:


    Develop, implement, and maintain the software quality assurance program for GxP systems in medical device and pharmaceutical products, in accordance with industry standards, regulatory requirements, and company guidelines.

    Collaborate with cross-functional teams, including software development, project management, and regulatory affairs, to ensure quality objectives are met throughout the software development lifecycle.

    Review and approve software documentation for GxP systems, including requirements, design specifications, test plans, and test results, to ensure compliance with applicable regulations and standards.

    Design, execute, and analyze test cases to verify that the GxP systems meet defined requirements and identify defects or deviations from expected performance.

    Conduct root cause analysis of software defects in GxP systems and collaborate with the development team to implement corrective and preventive actions.

    Monitor, analyze, and report on GxP system software quality metrics, such as defect density, test coverage, and pass/fail rates, to identify trends and areas for improvement.

    Participate in internal and external software quality audits, as well as regulatory inspections, as needed.
    Support continuous improvement initiatives by identifying opportunities to enhance GxP system software quality processes and methodologies.
    Provide guidance and training to team members on GxP system software quality assurance best practices and regulatory requirements.

    Stay informed on industry trends, new technologies, and regulatory changes to ensure continued compliance and competitiveness in the medical device and pharmaceutical market.


    Requirements:
    Bachelor's degree in Computer Science, Engineering, or a related field.

    A minimum of 2-5 years of experience in software quality assurance, preferably in the medical device or pharmaceutical industry, with a focus on GxP systems.

    In-depth knowledge of GxP regulations, software development processes, software testing methodologies, and quality management systems (e.g., ISO 13485, ISO 14971, IEC

    Familiarity with FDA and other international regulatory requirements for medical device and pharmaceutical GxP system software (e.g., 21 CFR Part 11, EU Annex 11, GAMP 5).

    Proficiency in various programming languages, such as C++, Java, or Python, and experience with software development tools, such as version control systems, bug tracking systems, and automated testing tools.

    Strong analytical, problem-solving, and decision-making skills, with the ability to identify root causes and implement effective corrective actions.
    Excellent communication and interpersonal skills, with the ability to work effectively both independently and in a team environment.
    Strong attention to detail and a commitment to delivering high-quality GxP system software solutions.
    Certified Software Quality Engineer (CSQE) or other relevant certifications are a plus.

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