Principal I, Research & Development Quality Assurance (T)
Alcon (company site, opens in a new tab)5+ yrsBengaluruOn-siteDirect career pageEst. 12–22 LPA
Posted 11h ago
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Job description
Structured overview of role & requirements
About This Role
- Provide QA oversight and governance for Digital Health software tools and related supporting systems to ensure compliance with regulatory standards (21 CFR Part 11, GAMP, CSA/CSV, ISO 13485, GxP).
- Lead review, assessment, and approval of testing and validation strategies, evidence, defect evaluations, and change control activities within an Agile delivery framework.
- Support global teams across USA and India time zones, contribute to audit readiness, and provide strategic guidance for post-market quality assurance activities.
Minimum Requirements
- Bachelor’s degree in engineering, computer science, life sciences, or related field.
- 5+ years of relevant experience in software QA or validation within a regulated environment.
- Working knowledge of CSV, CSA, 21 CFR Part 11, change control, GxP systems, and ISO 13485 medical device environment.
- Ability to work flexible hours from 1 PM to 10 PM IST, collaborating with cross-functional global teams.
Ideal Candidate Profile
- Experienced in risk-based validation and testing assessments within regulated digital health or medical device software environments.
- Skilled at integrating QA activities into Agile development processes, working independently on complex tasks and key technical decisions.
- Comfortable supporting audits, regulatory inspections, and coordinating across multiple time zones with IT, development, and business stakeholders.