Associate II, Quality Operations

Alcon Research•Houston, TX

2d•Onsite

About The Position

The Associate II, Quality Operations role is part of Alcon’s Quality & Regulatory Affairs function, which ensures products comply with global, local, and internal regulations and meet quality standards. This professional-path position handles complex quality tasks and contributes to advanced quality management projects across manufacturing and distribution processes. The associate monitors product quality, resolves non-conformances, maintains compliant documentation, and applies advanced quality management knowledge. The role is onsite, with a Monday–Friday schedule from 8:00 AM to 5:00 PM CST and no travel required. Sponsorship and relocation are not available.

Requirements

Bachelor’s degree or equivalent years of directly related experience; alternatively, high school education plus 8 years of experience or an associate degree plus 4 years of experience.
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 independent decisions within assigned project areas to drive quality outcomes and operational effectiveness.
Monitor product quality across manufacturing and distribution stages and ensure timely resolution of non-conformances.
Lead and document investigations related to deviations, non-conformances, and quality events in accordance with established procedures.
Conduct root cause analyses using methodologies such as 5 Whys, Fishbone Analysis, FMEA, and other problem-solving tools.
Develop, implement, and monitor corrective and preventive action (CAPA) plans to mitigate risk, prevent recurrence, and improve process performance.
Collaborate with Manufacturing, Quality, Engineering, and Regulatory Affairs teams on investigations and sustainable CAPA implementation.
Communicate investigation status, findings, risks, and scope updates to leadership and key stakeholders.
Prepare and present investigation reports, CAPA summaries, and supporting documentation for management reviews and regulatory inspections.
Maintain accurate quality records and documentation in compliance with GxP regulations and internal procedures.
Ensure adherence to Standard Operating Procedures (SOPs), training requirements, and applicable industry regulations.
Participate in internal and external audits, providing quality system support, CAPA documentation, and responses as required.
Analyze quality data and trends to identify opportunities for continuous improvement and enhanced process performance.
Conduct independent research and apply critical thinking to support quality initiatives and optimize business outcomes.
Meet individual performance expectations while contributing to organizational quality and compliance objectives.