Senior Software Quality Assurance Engineer
2 weeks ago
Software Quality Assurance Engineer
The Software Quality Assurance Engineer is tasked with the strategic planning, execution, and documentation of verification processes for software applications and medical devices. This role requires collaboration within a multidisciplinary team to comprehend assigned tasks and enhance product quality. As a proactive contributor, the engineer will foster effectiveness, efficiency, and adherence to compliance standards within the team. The ability to estimate timelines and schedules, along with providing clear and concise updates to management, is essential to demonstrate progress towards overarching project objectives.
Key Responsibilities
• Evaluate and provide insights on existing test verification practices to ensure alignment with FDA/ISO regulations.
• Collaborate with leadership and development teams to implement industry best practices.
• Develop and refine processes and procedures for Design Verification, including the identification of necessary tools.
• Support the clarification of requirements and user stories to integrate verification perspectives.
• Exhibit advanced skills in developing test cases for system-level testing.
• Produce high-quality, compliant test plans and cases using Microsoft TFS/Azure DevOps and associated tools.
• Design, implement, and execute both manual and automated testing protocols.
• Contribute to the formulation of system-level testing strategies.
• Assist in the creation and development of testing systems required for verification.
• Engage in requirements development and system-level document evaluations.
• Manage defect logging, tracking, and reproduction processes.
• Provide constructive feedback to enhance various verification-related processes.
• Conduct bug reproduction, logging, and triage activities.
• Occasionally oversee project management tasks related to development initiatives.
• Identify challenges and meet project deadlines while undertaking additional tasks as assigned.
Qualifications
• A degree or certification in a scientific or technical discipline, or relevant work experience is required.
• Extensive experience in design verification for medical software devices.
• Proficiency with Microsoft Test Manager (MTM) and Microsoft TFS/Azure DevOps.
• Experience in both manual and automated testing environments.
• Familiarity with Agile testing methodologies.
• Experience in testing and troubleshooting peripheral device communication and connectivity (e.g., Bluetooth/USB).
• Background in testing systems within the medical industry.
• Knowledge of FDA's Quality System Regulation (CFR 820) and/or ISO 13485 is preferred.
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