Senior Software Quality Engineer

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: 

• Bachelor’s 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)