Principal I, Research & Development Quality Assurance (T)

Summary of Position:

We are seekingaQualityAssurance Engineer to provide QA oversight for Digital Health software tools andcustomerfacingsupporting software systems and infrastructure within a regulated environment.

In this role you will work closely with IT software development and business teams to ensure systems are developed tested changedmigratedand maintained in compliance with 21 CFR Part 11 GAMP Computerized System Validation (CSV) / Computer Software Assurance (CSA) ISO 13485 and applicableGxPexpectations using an Agile delivery model.

This role focuses on quality oversight review assessment and approval of testing and validation activities rather than execution ofhandsontesting.

This role supports global teams across the USA (Central and Pacific time zones) and India (IST) and requires flexibility to collaborate across time zones.

Key Responsibilities:

• Provide QA oversight for Digital Health software tools andcustomerfacingsupporting software systems and infrastructure

• Apply CSV and CSAriskbasedapproaches to review and assess validation and testing strategies

• PerformGxPand impact assessments to helpdeterminevalidation scope and testing needs

• Assess and support change control activities including validation and risk impact assessments

• Ensure systemsremainin 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

• Providesstrategic guidance for post-market support activities

• Operates independently on complex tasks and contributes to critical QA technicaldecisions.

Key Requirements/Minimum Qualifications:

• Bachelors degree in engineering computer science life sciences or a related field
• 5yearsrelevant 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 andimpactassessments

• Experience supportingGxPsystems

• Experience working in an ISO 13485 medical device environment

• Familiarity with Agile development environments

• Ability to work effectively with globalcross functionalteams

Preferred Qualifications/Skills/Experience

• Experience supporting systems used in IT development orcloudoperations

• Familiarity with Agile tools such as Jira or ServiceNow

• Experience supporting audits or regulatory inspections

• Strong communicationand collaboration skills

Work hours: 1 PM to 10 PM IST

Relocation assistance: Yes

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