Associate I, Quality Operations

Alcon

Fort Worth (TX)

On-site

USD 55,000 - 75,000

Full time

5 days ago
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Benefits offered by this job

Health insurance
Retirement plan
Paid time off
Flexible time off for exempt
PTO for hourly associates

Job summary

Alcon is seeking an Associate I, Quality Operations to monitor product quality, resolve non-conformances, and maintain documentation. You will apply advanced quality management practices, support tech transfers, and participate in validation activities across production areas.

Qualifications include a Bachelor’s degree or equivalent, English fluency, and experience with Excel, PowerPoint, and Minitab. Travel 5-10% and onsite work are expected.

Qualifications

  • Bachelor's degree required or equivalent years of related experience.
  • Fluent English reading/writing/communication.
  • Experience in medical devices/pharmaceuticals preferred.
  • Knowledge of Excel, PowerPoint and Minitab.
  • Strong analytical and problem-solving skills.

Responsibilities

  • Interact with other facilities to support product tech transfer.
  • Support product validations through data collection and execution.
  • Maintain validation protocols and write final technical summaries.
  • Investigate non-conformances, CAPA, and corrective actions.
  • Track NC and CAPA data using statistical and non-statistical tools.
  • Assist on production floor to support processes and improvements.

Skills

Quality assurance
Data analysis
Statistical tools
Communication
Regulatory knowledge

Education

Bachelor's degree in Engineering or related

Tools

Excel
PowerPoint
Minitab

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.

The Associate I, Quality Operations is primarily responsible for applying specialized knowledge to support project goals by monitoring product quality, resolving non-conformances, and maintaining documentation. You will use advanced quality management practices and conduct independent research.

In this role, a typical day will include:
  • Interact effectively with other facilities to support product tech transfer.
  • Support product validations through data collection.
  • Support/ execute validations, product, equipment, and manufacturing processes.
  • Ensure adequate product and process controls are in place for identified critical or major quality attributes/process parameters within assigned production areas.
  • Investigate and/or provide input on non-conformance events (NC), Corrective Actions, and Preventive Actions (CAPA) while providing guidance and approval.
  • Ensure supplier-related quality issues (i.e. customer complaints, non-conformances) with assigned commodities are corrected to prevent recurrence. Partner with the supplier on the use of root cause analysis tools paired with a formal corrective action process.
  • Ensures immediate action, including for cause visits, is taken with suppliers on issues deemed critical.
  • Track and trend NC and CAPA data with guidance using various statistical and non-statistical problem-solving tools as part of the analysis.
  • Lead product holds and quarantine when necessary.
  • Assist Manufacturing, Engineering, and other Quality functions to create a presence on the production floor to support the production process.
  • Support and promote improvement activities for production areas.
  • Uses various statistical and non-statistical problem-solving tools to analyze data, issues, or improvement opportunities.
  • Administer validation protocols associated with product/process changes including writing the initial protocol for qualification, scheduling the logistics of the protocol run with manufacturing, product testing, and evaluation writing a final technical summary to include conclusions drawn from the test data and subsequent recommendations.
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: Exempt
  • Work Location: Onsite
  • Travel Requirements: 5-10%
  • Relocation assistance: None
  • Sponsorship available: No
PREFERRED QUALIFICATIONS, SKILLS, & EXPERIENCE
  • Bachelor's degree in Engineering (e.g., Mechanical, Industrial, Biomedical, or related field) preferred, recent graduates are encouraged to apply
  • Experience with medical devices or pharmaceuticals
  • Knowledge of Excel, Power Point and Minitab
  • Strong analytical, communication, and problemsolving skills
  • Ability to work collaboratively in a fastpaced, regulated environment
  • Interest in quality systems, manufacturing processes, and continuous improvement
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 a robust benefits package including health, life, retirement, flexible time off for exempt associates, PTO for hourly associates, and much more!

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.

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