R&D Principal Quality Operations Engineer I

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you'll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.

We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As a R&D PRINCIPAL QUALITY OPERATIONS ENGINEER I supporting our QUALITY TEAM, you will be Responsible for supporting the design of new product development (NPD) projects and overseeing the quality operations activities as required for pilot line production at FORT WORTH MAIN, IN FORT WORTH, TX. USA.

• Support design of new product development (NPD) projects by:.

  • Ensuring global product development activities are in full compliance with Alcon and 21 CFR/ISO requirements as well as associated international regulations/standards.

  • Developing design control and quality strategies for projects.

  • Reviewing, approving and/or being actively involved in the development of NPD process protocols and final reports (including but not limited to master validation plans, cleaning validation, test method validation, process validation, computer system validation, and product development plans, specifically components that focus on design reviews, quality plans, design transfer and design verification/validation)

  • Participation in project core teams to provide Quality guidance to development phases of designated projects.

  • Provide Quality support to ensure Design History File is complete and accurate during the development stages. Strongly participate in the design review process including but not limited to: Developing design review documentation.

• Oversee and guide the pilot manufacturing areas to comply with Quality System requirements and review/approve proposed product, process, and document changes. Supports product development and validations through data collection, review, and approvals of protocols/reports, etc.

• Ensure there are adequate product and process controls in place for identified critical or major quality attributes/process parameters within pilot manufacturing area. Complete GAP analysis against local, global, and industry standards, as needed, and support development/execution of actions to close gaps with little to no management guidance.

• Manage, control and disposition of incoming material, including release, and nonconforming materials.

• Partner with pilot, process engineering, Quality Engineering and, other functions to ensure a QA presence in the pilot areas to support the process. Complete routine walkthrough of the areas and evaluate processes and systems for conformance to local, global and industry standards/requirements.

• Provide Quality oversight to Clinical lots manufacturing and Clinical distribution activities

• Bachelor's Degree or Equivalent years of directly related experience (with high school diploma +13 yrs; with Assoc. degree +9 yrs; M.S.+2yrs; PhD+0 yrs)

• The ability to fluently read, write, understand and communicate in English

• 5 Years of Relevant Experience

• Work hours: Monday through Friday - 8:00am - 5:00pm

• Travel Requirements: 0 to 10%

• Relocation assistance:No

• Sponsorship available: No

• B.S. degree in scientific/engineering discipline, Certified Quality Engineer (CQE), Six Sigma Certification

• Experience in a Quality role in a FDA regulated industry for Medical Device, Pharmaceuticals or equivalent

• Knowledge of quality standards and application, including ISO 13485, 21CFR820, 21CFR210-211 and associated product / process standards.

• Knowledgeable in Design Control, Risk Management, manufacturing (aseptic experience preferred) and validation principles, statistics and/or process capability

• Independently scopes and implements technical solutions, making well-reasoned design quality decisions.

• Ability to interpret, analyze, and present technical information using practical judgment.

• Ability to lead teams and become a role model for change management and continuous improvement activities.

• Ability to organize and manage concurrent activities.

• Capable of functioning effectively in a team environment.

• Excellent written and oral communication skills.

• Demonstrated problem solving skills.

• Collaborate with teammates to share standard processes and learnings as work evolve.

• 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 robust benefits package including health, life, retirement, flexible time off for exempt associates; PTO for hourly associates, and much more!

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Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, 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 alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.