Principal I, Research & Development Quality Assurance

Responsibilities

• 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 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
• Collaborate with IT and development teams to support compliant system delivery
• Support audit and inspection readiness activities and provide strategic guidance for post-market support

Requirements

• Bachelor’s degree in engineering, computer science, life sciences, or a related field
• 5+ years of relevant 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 and working in an ISO 13485 medical device environment
• Familiarity with Agile development environments
• Ability to work effectively with global, cross-functional teams

Preferred Qualifications

• 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

About the Company

Alcon is a global leader in eye care, developing and manufacturing innovative devices to serve the full life cycle of eye care needs. From surgical equipment for cataract removal to consumer products like Opti-Free contact lens solutions, Alcon is committed to helping people see better across 180 countries worldwide.