Associate, Quality Assurance Engineering - A Shift

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 Associate, Quality Assurance Engineering, you will be trusted to lead activities involving assigned routine product inspections, product impact assessments for events, product quarantine activities, non-conformance reporting/issue resolution, auditing of production areas, and procedural updates to ensure the process and documentation is compliant with 21CFR820, ISO, and other regulatory requirements, as well as internal requirements at our Manufacturing Facility in Houston, TX!

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.). Analyzes audit results for trends and gives feedback to the QA Operations Management and QA team.

• Actively participates in the Production Triage team as the lead Quality member by providing direction and support on the non-conformance 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.

• Performs Product Quarantine activities, such as entering product into quarantine, completing quarantine documentation, reviewing and disposition of non-conformance records for quarantine release, and removal of product from the 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 Operations process improvements from start to implementation, including creating/revising procedures using the Change Control process.

• Collaborates with Operations, Quality Engineering, Compliance, and Engineering personnel and participates in work groups to help improve the process and increase product quality while keeping within compliance with site Quality Systems procedures.

• Leads and/or supports 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)

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

• Work Hours: A Shift (12 hours): Monday – Wednesday and every other Thursday, 4:00 AM – 4:30 PM CST

• Location: Onsite

• Travel Requirements: 0 – 10%

• Relocation Assistance: None

• Sponsorship Available: No

Preferred Qualifications:

• Experience in Medical Device/Pharmaceutical regulated industry.

• Excellent oral and written communication, and organizational and teamwork.

• Proficient in Microsoft Office (Word, PowerPoint, Excel, etc.).

• Ability to work through complex issues and differences in a creative, constructive, and diplomatic manner.

• Ability to manage multiple tasks with limited supervision.

How You Can Thrive at Alcon:

• Collaborate with teammates to share standard processes and learnings 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 and life insurance, retirement, flexible time off for exempt associates, paid time off 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 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 alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.