Software Quality Engineer 2

Position Summary

Tasks and Responsibilities

• Provide software quality support across the Software Development Life Cycle (SDLC) for assigned program (s)
• Collaborate with cross-functional teams (Software Development, Program Management, Product Security, etc.) to support execution of quality activities
• Provide support on software development projects through review and approval of deliverables , including :
• Software Development Plans, Verification Plans, Validation Plans
• Product/Software Requirements
• Software Architectural and Design Documents
• Test Protocols, Requirement Traceability Matrix, Test Reports
• Cybersecurity and risk-related documentation
• Assist teams in determining verification and validation needs and requirements
• Participate in software risk management activities throughout the product lifecycle
• Participate in design reviews to support effective development, transfer, and maintenance of software products
• Provide support for software-related quality issues (e.g., complaints, CAPA), including investigation and resolution activities
• Identify opportunities for process improvements and support implementation of continuous improvements in the Software Quality Program
• Support development and delivery of training on software quality processes and practices
• Provide support for new technology areas (e.g., AI/ML, Cybersecurity, Cloud) as applicable to software systems and tools
• Support internal and external audits related to product software and software quality processes
• Escalate risks and issues as appropriate to ensure timely visibility and resolution
• Support other areas of the Quality System and perform additional tasks as defined by management
• All listed tasks and responsibilities are deemed essential functions to this position; however, business conditions may require reasonable accommodation for additional tasks and responsibilities.

Preferred Education

Job Requirements

• 2+ years’ experience in (software) quality engineering or related role in a regulated industry
• Working knowledge of applicable industry standards and regulations ( e . g ., IEC 62304, ISO 13485 , 21 CFR )
• Basic understanding of software development lifecycle (SDLC) processes and software engineering best practices
• Ability to execute assigned quality tasks with guidance and direct ion
• Experience working with cross-functional teams in a collaborative environment
• Good interpersonal, verbal, and written communication skills
• Ability to apply core Quality Engineering principles, including documentation and risk management basics
• Ability to work in a fast-paced and dynamic environment
• Experience in a global delivery model preferred
• Occasional travel may be required
• Willingness to work in shifts to support the US region (No night shift required )