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Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most significant health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

Software Quality Assurance Engineer II

About The Role

The Software Quality Assurance (SWQA) Engineer II provides quality and compliance support for medical device software development programs. This role partners with cross-functional teams to ensure software products are developed, verified, validated, and maintained in accordance with company procedures, regulatory requirements, and industry standards. Responsibilities include software design controls, risk management, verification and validation reviews, change assessments, and quality oversight throughout the product lifecycle.





Key Responsibilities

• Provide Quality Assurance support for software development and sustaining engineering projects.
• Review software lifecycle deliverables including requirements, design documentation, traceability artifacts, verification and validation protocols/reports, and release documentation.
• Participate in software risk management activities, including hazard analysis, risk assessments, and verification of risk controls.
• Review software verification and validation activities to ensure appropriate coverage, traceability, and objective evidence.
• Support Software Change Assessments (SCA), impact assessments, CAPA, remediation, and post-market quality activities.
• Partner with R&D;, Systems Engineering, Regulatory Affairs, and Program teams to ensure compliance with software design control requirements.
• Support compliance with applicable standards and regulations, incl

📌 Engineer II, Software Quality Assurance (Gurugram)
🏢 BOSTON SCIENTIFIC
📍 Gurugram