Associate II, Quality Operations

Alcon•Houston, TX

3d•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 quality systems knowledge. The position makes independent decisions within assigned project areas to drive quality outcomes and operational effectiveness. The role works with Manufacturing, Quality, Engineering, and Regulatory Affairs teams to investigate quality events, implement sustainable corrective and preventive actions, maintain compliant quality records, and support audits and regulatory inspections. Work is onsite, Monday through Friday, 8:00 AM to 5:00 PM CST, with no travel required. Sponsorship and relocation are not available.

Requirements

Bachelor’s degree or equivalent years of directly related experience; alternatively, high school diploma plus 8 years of experience or 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 in manufacturing and distribution.
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 into deviations, non-conformances, and quality events according to established procedures.
Conduct root cause analyses using methodologies such as 5 Whys, Fishbone Analysis, and FMEA.
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 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.