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Software Quality Assurance Engineer
2 months ago
We are seeking a highly skilled Software Quality Engineer to join our team at Amerit Consulting. As a Software Quality Engineer, you will play a critical role in shaping the process for defining and documenting software-centric design control elements and deliverables, ensuring alignment with regulatory requirements such as FDA guidance, and meeting both user and business needs.
Key Responsibilities:- Software Process Definition: Develop and implement software processes that comply with industry standards and regulations (e.g., IEC 62304, FDA guidance, IEEE standards), with a focus on the complete software development lifecycle.
- Software Design Documentation Remediation: Develop or modify and implement software design documentation templates within the Quality Management System that comply with industry standards and regulations. Clearly demonstrate end-to-end traceability where software design control elements are included, and remediate gaps and errors as needed.
- Leadership: Translate business and regulatory requirements into comprehensive software development processes. Conduct back testing and work collaboratively to ensure alignment with additional stakeholders, development teams, and business objectives. Maintain frequent and clear communication with team members and leaders working in all areas of the project. Identify risks and issues early on and implement mitigations as necessary.
- Cross-Functional Collaboration: Facilitate effective knowledge sharing and collaboration across departments (e.g., Systems Engineering, Hardware Engineering, Test Engineering, Quality, and others) to resolve alignment or feasibility issues. Communicate relevant project information effectively (verbal and written) including project status, technical concepts and design details, and functional demonstrations to key internal and external stakeholders of varying technical abilities.
- Continuous Improvement: Identify and drive opportunities for process improvement within the Software Engineering function to enhance efficiency, quality, clarity, and compliance.
- Technical Expertise: Serve as a resource for addressing and resolving issues of process and documentation. Apply best practices from methodologies like DFSS (Design for Six Sigma) and Critical Parameter Management to all projects. Review and remediate software design control documentation.
- Education: Bachelor's degree in Science or Engineering is required; a postgraduate degree is preferred
- Experience: Minimum of 5 years of related work experience in software engineering, medical device development, or similar fields; experience with regulatory standards (e.g., IEC 62304, FDA guidance, IEEE standards) in a regulated industry is highly preferred
- Leadership and Technical Skills: Demonstrated ability to lead multi-disciplinary engineering teams and serve as a technical leader within the organization. Strong background in software engineering and test, and requirements management
- Additional Requirements: Experience in software product development, including user needs assessment, software system analysis, architectural design, integration and testing, Reliability Engineering, Project Management, and Failure Modes Effects Analysis. Extensive experience in the creation and maintenance of design and development documentation is preferred. Knowledge and experience with methodologies like DFSS or statistical test design and analysis is preferred. Experience in Quality engineering and design control management is a plus. Experience with ALM/PLM tools is a plus. Experience working in an agile development environment is a plus.
Amerit Consulting is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating a workplace that is inclusive and respectful of all employees. If you are a motivated and experienced Software Quality Engineer looking for a new challenge, please submit your application.
