Associate II, Quality Operations

AlconHouston, TX
Onsite

About The Position

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. 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 II, Quality Operations (Professional Path) is primarily responsible for handling complex tasks and contributing to advanced quality management projects. This role involves monitoring product quality, resolving non-conformances, and maintaining documentation while applying advanced quality management knowledge. Alcon is committed to helping people see better, providing access to quality eye care, and developing innovative devices to serve the full life cycle of eye care needs. Its surgical group is one of the largest makers of equipment used for cataract removal and laser vision correction. Its consumer products include the well-known Opti-Free line of contact lens solutions and related products. Alcon, which was founded in 1945, sells its products in 180 countries worldwide.

Requirements

  • 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

Responsibilities

  • Handle complex tasks and contribute to advanced quality management projects within manufacturing and distribution processes
  • Make significant decisions within your project area to influence outcomes
  • Monitor product quality at different stages and resolve non-conformances promptly
  • Maintain relevant documentation and records
  • Conduct independent research and thought leadership activities to optimize outcomes
  • Ensure compliance with industry standards and regulations, adhering to Good Practice (GxP) regulations by following Standard Operating Procedures (SOPs), maintaining accurate documentation, and completing required training
  • Meet individual job requirements and contribute to overall organizational compliance
  • Lead and document CAPA investigations for non-conformances and deviations
  • Conduct thorough root cause analyses using appropriate methodologies (e.g., 5 Whys, Fishbone Analysis, FMEA, etc.)
  • Develop corrective and preventive action plans to mitigate risks and improve processes
  • Collaborate with cross-functional teams, including manufacturing, quality, engineering, and regulatory teams, to ensure thorough deviation investigation and CAPA effectiveness
  • Communication of status of investigation to leaders in organization, including update to deviation scope(s)
  • Prepare and present investigation reports and CAPA summaries to management and regulatory auditors
  • Participate in internal and external audits, providing CAPA-related documentation and responses as needed
  • Identify trends in quality issues and recommend continuous improvement initiatives

Benefits

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