Engineer II, Software Quality Assurance

Overview

The Software Quality Assurance (SWQA) Engineer II provides quality and compliance support for medical device software development programs, partnering with cross-functional teams to ensure software is developed, verified, validated and maintained in accordance with company procedures, regulatory requirements and industry standards.

What you'll do

• 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, including IEC 62304, ISO 13485, ISO 14971, and FDA QSR.
• Participate in continuous improvement initiatives and support audit readiness activities.

What you'll need

• Bachelor's degree in Computer Science Engineering, Software Engineering, or equivalent.
• 3+ years of experience in Software Quality, Software Development, Software Verification & Validation, or related engineering function.
• Knowledge of Software Development Lifecycle (SDLC) processes.
• Strong analytical, problem-solving, and communication skills.
• Ability to work effectively in a cross-functional environment.

Nice to have

• Experience in a regulated industry such as Medical Devices, Healthcare, Aerospace, or Automotive.
• Knowledge of IEC 62304, ISO 13485, ISO 14971, and FDA Design Controls.
• Experience with software design controls, risk management, and software validation.
• Familiarity with Agile development methodologies and lifecycle management tools such as Windchill, Jira.
• Exposure to cybersecurity, CAPA, remediation, or post-market quality activities.

Details

• Location: Gurgaon, India.
• Requisition ID: 635987.