Principal I, Research & Development Quality Assurance (T)

Overview

Provide QA oversight for Digital Health software tools and customer-facing supporting software systems and infrastructure within a regulated environment, working with IT, software development and business teams to keep systems compliant and validated under an Agile delivery model.

What you'll do

• Provide QA oversight for Digital Health software tools and customer-facing supporting software systems and infrastructure
• Apply CSV and CSA risk-based approaches to review and assess validation and testing strategies
• Perform GxP and impact assessments to help determine validation scope and testing needs
• Assess and support change control activities, including validation and risk impact assessments
• Ensure systems remain in a validated state throughout their lifecycle through oversight and governance
• Integrate QA and validation oversight activities into Agile sprints and releases
• Review requirements and user stories for quality, testability, and traceability
• Review and approve testing evidence, defect assessments, and retesting outcomes as appropriate
• Collaborate with IT and development teams to support compliant system delivery
• Support audit and inspection readiness activities as needed
• Provide strategic guidance for post-market support activities
• Operate independently on complex tasks and contribute to critical QA technical decisions

What you'll need

• Bachelor's degree in engineering, computer science, life sciences, or a related field
• 5+ years relevant experience
• Experience in software QA or validation within a regulated environment
• Working knowledge of CSV, CSA, and 21 CFR Part 11
• Experience performing change control and impact assessments
• Experience supporting GxP systems
• Experience working in an ISO 13485 medical device environment
• Familiarity with Agile development environments
• Ability to work effectively with global, cross-functional teams

Nice to have

• Experience supporting systems used in IT development or cloud operations
• Familiarity with Agile tools such as Jira or ServiceNow
• Experience supporting audits or regulatory inspections
• Strong communication and collaboration skills

Details

• Location: Bangalore, India
• Supports global teams across the USA (Central and Pacific time zones) and India (IST) and requires flexibility to collaborate across time zones
• Work hours: 1 PM to 10 PM IST
• Relocation assistance: Yes