Principal II, Research & Development Quality Assurance
On-siteFort Worth, Texas, United States
Job Summary
Oversee quality of R&D activities and ensure compliance with quality engineering support for design and development of surgical ophthalmic medical devices, including new product development and product changes. Review implementation of the quality system to ensure adherence to regulatory requirements in R&D processes for development of products, post-market improvements, lifecycle management, and transfer to Manufacturing. Operate independently to provide oversight of quality and compliance operations, manage individual technical projects, and make operational decisions for projects while assuring successful development, documentation, quality control, and validation of high-quality medical devices. Lead resolution of deviations and Corrective and Preventive Actions, directing R&D personnel to execute appropriately while adhering to GxP regulations and SOPs. This role supports the QA R&D Surgical Team in Fort Worth, TX, ensuring products meet global, local, and internal regulations as part of Alcon's mission to enhance sight.
Required Qualifications
- Bachelor's Degree or Equivalent years of directly related experience (or high school +13 yrs; Assoc.+9 yrs; M.S.+2 yrs; PhD+0 yrs)
- The ability to fluently read, write, understand and communicate in English
- 5 Years of Relevant Experience
- Compliance with regulatory requirements and a commitment to continuous improvement are essential to our operations
Desired Qualifications
- Certified Quality Engineer (CQE) or other relevant ASQ certification
- Knowledge of FDA 21 CFR Part 820, ISO 13485, and ISO 14971
- Experience supporting Design Controls and Risk Management for Class II and Class III medical devices
- Experience with quality engineering support for medical device product development and design transfer
- Knowledge of CAPA, Nonconformance Management, and Root Cause Analysis
- Familiarity with EU MDR, MDSAP, and global regulatory requirements
- Knowledge of surgical ophthalmic medical devices and ISO 11979 standards
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