Senior Software Quality Engineer

Shift time - 2pm to 11pm

Location - Bangalore

Tasks and Responsibilities:

Serve as a subject matter expert (SME) in Software Quality Engineering and act as the primary quality partner for assigned projects

• Provide end-to-end software quality support across the software development life cycle (SDLC), with ownership of quality deliverables for assigned areas
• Collaborate with global cross-functional teams (Software Development, Program Management, Product Security, etc.) across time zones to ensure alignment and execution
• Review and approve development 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 strategies, ensuring alignment with regulatory and quality requirements
• Participate in and drive software risk management activities throughout the product lifecycle
• Provide review and approval of software-related orders
• Participate in design reviews to ensure effective development, transfer, and maintenance of software products across the lifecycle
• Provide support for software related issues (Complaints, CAPA, etc.), including investigation, resolution, and identification of systemic improvements
• Identify and make recommendations for continuous improvement of the Software Quality Program
• Assist in the development and delivery of training to employees on quality processes and practices
• Provide support and guidance with new technologies development (e.g., AI/ML, Cybersecurity, Cloud, etc.) as it relates to software systems and tools
• Support internal and external audits related to product software and software quality processes
• Contribute to building and scaling Software Quality Engineering capability within the India team, including standardization of processes and best practices
• Escalate potential risks and issues to management proactively to ensure visibility and timely 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:

• Bachelors degree in Computer Science, Software Engineering, Bioinformatics, Biomedical or related discipline

Job Requirements:

• 5+ years experience in (software) quality engineering or related role in a regulated industry
• Working knowledge of relevant industry standards and regulations (e.g., IEC 62304, ISO 13485, 21 CFR)
• Strong understanding of software development lifecycle (SDLC) processes and software engineering best practices
• Experience working in a global delivery model with cross-functional teams across geographies preferred
• Ability to independently own and execute quality activities for assigned programs with minimal supervision
• Ability to operate effectively in a fast-paced and dynamic environment
• Strong collaboration skills with cross-functional teams (Software Development, Program Management, Product Security, etc.) to drive a culture of quality
• Good interpersonal, verbal and written communication skills
• Ability to apply Quality Engineering principles effectively, including structured development processes and risk management
• Quality and/or Regulatory Certifications (ASQ, AAMI, RAPS, etc.) preferred
• Experience mentoring or guiding junior engineers preferred
• Occasional travel may be required
• Willingness to work in shifts to support the US region (No night shift required)