Principal II, Research & Development Quality Assurance

At Alcon were passionate about enhancing sight and helping people see brilliantly. With more than 25000 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 Alcons 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 Alcons quality requirements. Youll 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 YOULL BRING TO ALCON:

• Bachelors Degree or Equivalent years of directly related experience (or high school 13 yrs; Assoc.9 yrs; M.S.2 yrs; PhD0 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 Alcons 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

If you are currently an active employee/contingent worker at Alcon please click the appropriate link below to apply on the Internal Career site.

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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 and let us know the nature of your request and your contact information.