Summary of Position:
We are seeking a Quality Assurance Engineer to provide QA oversight for Digital Health software tools and customer‑facing supporting 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, changed, migrated, and maintained in compliance with 21 CFR Part 11, GAMP, Computerized System Validation (CSV) / Computer Software Assurance (CSA), ISO 13485, and applicable GxP expectations, using an Agile delivery model.
This role focuses on quality oversight, review, assessment, and approval of testing and validation activities, rather than execution of hands‑on testing.
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:
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Provide QA oversight for Digital Health software tools and customer‑facing supporting software systems and infrastructure
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Apply CSV and CSA risk‑based approaches to review and assess validation and testing strategies
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Perform GxP and impact assessments to help determine validation scope and testing needs
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Assess and support change control activities, including validation and risk impact assessments
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Ensure systems remain in a validated state throughout their lifecycle through oversight and governance
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Integrate QA and validation oversight activities into Agile sprints and releases
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Review requirements and user stories for quality, testability, and traceability
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Review and approve testing evidence, defect assessments, and retesting outcomes as appropriate
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Collaborate with IT and development teams to support compliant system delivery
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Support audit and inspection readiness activities as needed
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Provides strategic guidance for post-market support activities
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Operates independently on complex tasks and contributes to critical QA technical decisions.
Key Requirements/Minimum Qualifications:
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Bachelor’s degree in engineering, computer science, life sciences, or a related field
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5+ years relevant experience.
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Experience in software QA or validation within a regulated environment
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Working knowledge of CSV, CSA, and 21 CFR Part 11
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Experience performing change control and impact assessments
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Experience supporting GxP systems
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Experience working in an ISO 13485 medical device environment
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Familiarity with Agile development environments
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Ability to work effectively with global, cross functional teams
Preferred Qualifications/Skills/Experience
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Experience supporting systems used in IT development or cloud operations
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Familiarity with Agile tools such as Jira or ServiceNow
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Experience supporting audits or regulatory inspections
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Strong communication and collaboration skills
Work hours: 1 PM to 10 PM IST
Relocation assistance: Yes
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