Associate II, Quality Operations

Alcon Research•Houston, TX

1d•Onsite

About The Position

The Associate II, Quality Operations (Professional Path) is part of Alcon’s Quality & Regulatory Affairs function. The role manages complex quality processes, leads investigations, and contributes to advanced quality management initiatives. It supports product quality monitoring, non-conformance resolution, CAPA management, compliance activities, and continuous improvement across manufacturing and distribution operations, applying advanced knowledge of quality systems. The position is onsite, with working hours Monday through Friday, 8:00 AM to 5:00 PM CST, and no required travel. Sponsorship and relocation are not available. Alcon describes its mission as enhancing sight and helping people see brilliantly. The company offers growth and development opportunities and a benefits package that includes health, life, retirement, flexible time off for exempt associates, and PTO for hourly associates.

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.
Fluency in reading, writing, understanding, and communicating 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 throughout manufacturing and distribution and ensure timely resolution of non-conformances.
Lead and document investigations of 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 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 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 continuous-improvement opportunities and enhance 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.