Manager, Quality Operations, R&D Quality Assurance
Core
Design, deploy, and monitor Quality Systems for Alcon Instrumentation R&D to ensure compliance with global, local, and internal regulations.
Role type
Manager, R&D Quality Assurance
Builds
Quality systems and compliance frameworks for medical device instrumentation R&D
Domain
Medical Devices / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Systems design and deployment, Change control management, Non-conformance and investigation handling, CAPA (Corrective and Preventive Actions), Supplier management, Audit execution, Document control, GxP compliance, SOP development and revision, R&D personnel compliance oversight
Preferred skills
Medical device industry experience, Regulated industry background
Technologies
GxP, SOPs, CAPA, Change Control
Responsibilities
Manage individual projects to enhance operational efficiency, Develop and implement quality assurance strategies, Make operational decisions managing resources and timelines, Ensure accurate supporting documentation per design plan, Identify and contribute to SOP revisions, Ensure compliance of R&D activities and direct personnel execution
Seniority
Manager, hands-on leadership
