Senior Software Quality Assurance Engineer

Position Overview :

Senior Software Quality Engineer will be responsible for leading Quality Assurance and Quality Engineering activities throughout the Software Development Lifecycle for new product development projects, supporting manufacturing and production process improvements. The SWQE is responsible for ensuring the software development process is compliant with applicable standards, regulations and guidance documents for medical devices.

Key Responsibilities :

• Drive Design Control and software development initiatives to create Design History File (DHF) documentation in compliance with FDA and EU regulations.
• Lead risk management activities per ISO 14971 and IEC 62304 software risk requirements.
• Collaborate with cross-functional teams (software, hardware, UX, marketing, manufacturing, QA) on requirements generation, documentation, verification, and validation.
• Support development and validation of non-device software and software tools.
• Plan and execute validation testing for computerized systems used in production or quality systems.
• Provide guidance on, and participate in software development activities including design and code reviews, requirements analysis and tracing, defect tracking and configuration management
• Review requirements, specifications, product design documents, validation protocols, test plans, test cases, and other documentation as required and provide timely feedback.
• Establish and maintain software quality assurance programs, processes, procedures and controls to ensure compliance with FDA regulations and established standards such as IEC 62304
• Participate in audits, CAPA programs, and review DHFs and technical files for regulatory conformance.
• Provide expertise in software requirements, specifications, design, verification, and validation planning.
• Other duties as assigned.

Required Experience :

Skills & Abilities :