Principal II, Research & Development Quality Assurance

Role: Principal II, Research & Development Quality Assurance at Alcon, leading QA and compliance for ophthalmic research and development activities. Responsibilities: oversee quality of R&D design, development, and post-market processes; ensure adherence to regulatory standards such as GxP, ISO 13485, ISO 14971, and FDA 21 CFR Part 820; manage deviations, CAPA, and risk management; support design controls and product transfer for Class II/III medical devices; lead quality assurance support for medical device innovation. Requirements: Bachelor’s degree or equivalent, 5+ years relevant experience, proficiency in quality engineering, and understanding of medical device regulations. Preferred: CQE or ASQ certification, experience with EU MDR, MDSAP, and standards like ISO 11979, strong knowledge of surgical ophthalmic devices, and quality systems. Work setup: Onsite in Fort Worth, TX with 5% travel; relocation and sponsorship not provided. High-Value: Medical devices, ophthalmic surgical products, GxP compliance, design control, risk management, regulatory standards, and lifecycle quality assurance.