Principal II, Research & Development Quality Assurance

Alcon; Fort Worth (TX); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Flexible time off

Job summary

Alcon is seeking a Principal II, Research & Development Quality Assurance in Fort Worth, TX. You will lead QA and compliance for R&D activities, ensuring devices meet regulatory standards and Alcon’s quality requirements.

You’ll influence cross-functional teams and drive innovative solutions in a fast-paced environment. Key responsibilities include overseeing quality for design and development, applying CAPA and risk management, and ensuring successful transfer to manufacturing.

Qualifications

• Bachelor’s degree or equivalent required.
• 5+ years of relevant experience in quality assurance/regulatory affairs.
• Experience with medical devices and design transfer preferred.

Responsibilities

• Oversee QA for R&D activities and ensure compliance with quality systems and regulatory requirements for ophthalmic medical devices.
• Lead design controls, risk management, CAPA, and deviation resolution.
• Provide independent quality oversight and drive continuous improvement across R&D projects.

Skills

CQE certification

FDA 21 CFR 820

ISO 13485

ISO 14971

Design Controls

Risk Management

CAPA

Root Cause Analysis

Regulatory knowledge

Ophthalmic devices

Education

Bachelor’s Degree or Equivalent

Job description

At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers. Are you ready to join us?

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.

Specifics include

• 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.

WHAT YOU’LL BRING TO ALCON

• 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
• Worksite location: Onsite
• Travel: 5%
• Relocation: No
• Sponsorship Assistance: No

PREFERRED QUALIFICATIONS/SKILLS/EXPERIENCE

• 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

HOW YOU CAN THRIVE

• Collaborate with teammates to share standard processes and findings as work evolves
• See your career like never before with focused growth and development opportunities
• Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!
• Alcon provides a robust benefits package including health, life, retirement, flexible time off and much more.

ATTENTION: Current Alcon Employee/Contingent Worker

Alcon is an equal opportunity employer and participates in E-Verify

Alcon takes pride in maintaining an inclusive environment that values different perspectives and our policies are non-discriminatory in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to [e-mail] and let us know the nature of your request and your contact information.