Operation Quality 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 an Operation Quality Engineer I you will be conducting audits of personnel and process in manufacturing areas for practice versus procedures and against current regulatory requirements (FDA, ISO, etc.) at our facility HOUSTON, TEXAS, (US).

In this role, a typical day will include:

• Audits personnel and processes in manufacturing areas for practice versus procedures and against current regulatory requirements (FDA, ISO, etc.). Analyze audit results for trends and provide feedback to QA Ops Management and QA team.
• Actively participates in Production Triage team as the lead Quality member by providing direction and support on the nonconformance process, product impact assessment, root cause analysis, and product quarantine as non-conformances arise.
• Ensures non-conformance reports are initiated per established requirements and applicable activities are identified and implemented.
• Responsible for performing Product Quarantine activities, such as entering product into quarantine/MRB, completing quarantine documentation, reviewing/disposition non-conformance records for quarantine release and removal of product from quarantine area.
• Performs real time Quality review for correctness and completeness on assigned in-process documentation to support QA release decisions/activities.
• Ensures all required documentation is accounted for and ensures that the documentation is an accurate representation of activities on the production floor.
• Initiates and leads QA Ops process improvements from start to implementation including creating/revising procedures using the Change Control process.
• Interact in a team environment with Operations, Quality Engineering, Compliance, and Engineering personnel and participate in work groups to help improve the process and increase product quality while keeping within compliance with site Quality Systems procedures.
• Lead and/or support other duties as assigned.

WHAT YOU'LL BRING TO ALCON:

• Bachelor's Degree or Equivalent years of directly related experience (or high school +8 yrs; Assoc.+4 yrs) - Preferably degree in Biomedical Engineering/Medical Device Development.
• The ability to fluently read, write, understand and communicate in English
• Excellent oral and written communication, organizational, and teamwork skills are required
• Proficient in MicroSoft Office (Word, PowerPoint, Excel, etc.), TEAMS, SAP.
• Ability to work through complex issues and differences in a creative, constructive, and diplomatic manner.
• Ability to manage multiple tasks with limited supervision

Work hours: A shift - Mon-Wed, and every other Thursday (4:00 am -4:30 pm)

Travel Requirements: None

Relocation assistance: No

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

2 Years of Relevant Experience

Travel Requirements: 0 to 10%

Relocation assistance: Yes

• Sponsorship available: No

PREFERRED QUALIFICATIONS / SKILLS / EXPERIENCE: TBD

• Microsoft Office,Word, Excel, PowerPoint
• SAP knowledge
• Process Audit experience
• Root Cause analysis

HOW YOU CAN THRIVE AT ALCON:

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

Alcon Careers

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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.