Principal II, Research & Development Quality Assurance

Alcon Research•Fort Worth, TX

6d•Onsite

About The Position

This role is part of Alcon's Quality & Regulatory Affairs function, a team that ensures our products are in compliance with global, local, and internal regulations and meet the strictest standards of quality as we help people see brilliantly. As Principal II, Research & Development Quality Assurance supporting the QA R&D Surgical Team in Fort Worth, TX, you will be responsible for leading quality assurance and compliance for research and development functions, ensuring products and processes meet regulatory standards and Alcon’s quality requirements. You’ll use scientific expertise to solve complex problems, drive innovation, and influence cross-functional teams.

Requirements

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

Nice To Haves

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

Responsibilities

Responsible for overseeing the quality of R&D activities and ensuring compliance with quality engineering support and consultation for design and development of surgical ophthalmic medical devices, including new product development and product changes.
Focuses on reviewing the implementation of the quality system ensuring adherence to regulatory requirements in R&D processes for development of products / processes, post-market improvements, lifecycle management, ensuring successful implementation of design control and risk management processes, and transfer to Manufacturing.
Operates with independence from business partners to provide oversight of quality and compliance operations
Manage individual technical projects, applying specialized knowledge to achieve objectives and drive innovation.
Oversee quality assurance processes, ensuring compliance with technical standards and supporting continuous improvement initiatives.
Make operational decisions for projects, managing resources and technical aspects.
Assure successful development, documentation, quality control, validation, and transfer of high-quality and reliable medical devices.
Lead the resolution of individual deviations and Corrective and Preventive Actions.
Ensure compliance of all Research and Development activities within product development and direct Research and Development personnel to execute appropriately.
Adhere to Good Practice (GxP) regulations by strictly following Standard Operating. Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training.
Commit to continuous improvement and compliance with regulatory requirements.
Responsible for meeting their individual job requirements and contributing to the overall compliance of the organization.
Compliance with regulatory requirements and a commitment to continuous improvement are essential to our operations.