Software Quality Engineer - SaMD

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Written by AI from the job title and company, not by Fission Consulting Services, so some details may not match this job. The employer's own page has the real description.

Job Overview

Fission Consulting Services is seeking a dedicated and detail-oriented Software Quality Engineer specializing in Software as a Medical Device (SaMD). The ideal candidate will be responsible for ensuring quality in software products, particularly those used in the medical field. This role involves designing, implementing, and executing tests to validate software functionality and performance against user requirements. In addition, the Software Quality Engineer will collaborate with cross-functional teams to promote a culture of quality within the organization, ensuring compliance with regulatory standards and guidelines.

Job Responsibilities

• Develop and execute comprehensive test plans, test cases, and test scripts for SaMD applications.
• Identify, record, and track software defects and issues through systematic testing processes.
• Collaborate with software developers and product managers to ensure quality standards are integrated into the software development lifecycle.
• Perform risk assessments and contribute to the hazard analysis of SaMD to ensure compliance with regulatory requirements.
• Develop and maintain automated testing frameworks and tools.
• Participate in peer reviews of testing documentation and processes.
• Prepare and present testing reports and provide insights on quality metrics to stakeholders.
• Stay current with industry standards, practices, and emerging technologies related to software quality assurance.

Qualifications

• Bachelor's degree in Computer Science, Software Engineering, Biomedical Engineering, or a related field.
• Minimum of 3 years of experience in software quality assurance, with a focus on medical device software preferred.
• Proven experience in developing and executing test plans and automated testing using appropriate tools.
• Strong knowledge of FDA regulations and ISO standards applicable to medical devices.
• Excellent analytical and problem-solving skills.
• Familiarity with programming languages such as Python, Java, or C#.
• Strong communication and collaboration skills to work effectively within cross-functional teams.

Technologies & Tools

The Software Quality Engineer will utilize a variety of technologies and tools including automated testing frameworks such as Selenium or TestComplete, continuous integration tools like Jenkins or GitLab CI, bug tracking systems like JIRA, and version control tools such as Git. Proficiency in programming languages, specifically for developing scripts for automated tests, is essential for this position.

Ideal Candidates

The ideal candidate for the Software Quality Engineer position will be detail-oriented, proactive, and possess a strong commitment to quality. They should exhibit effective communication skills, fostering collaboration among diverse teams. A successful candidate will demonstrate a keen analytical ability to assess software performance and functionality, along with a robust understanding of regulatory standards in the medical device industry. The ability to adapt to evolving technologies and a passion for ensuring patient safety through software quality will set a candidate apart.