Associate, Quality Assurance Engineering

Alcon Research•Johns Creek, GA

1d•Onsite

About The Position

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 Quality Systems Engineer is primarily responsible for leading Quality Operations personnel to ensure compliance with Quality Systems in production areas. The Quality Systems Engineer (QSE) will with minimum guidance work with the Quality and Manufacturing team and support activities during the overall product life cycle of the assigned production platform. The QSE will work product transfers, improvement projects, change requests, quality issue resolution, CAPAs, process control, validations, and low risk e-compliance approvals.

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

Nice To Haves

Manage your own workload and schedule while hitting your set targets.
Build positive working relationships to achieve positive goals and business objectives.
Balance experiencing new environments and working autonomously in a remote sales environment.

Responsibilities

Directly supervise team members, ensuring efficient task completion and adherence to processes
Monitor product quality at various manufacturing and distribution stages
Resolve non-conformances, maintain documentation and records, and review batch production records
Conduct audits, manage inspection and test results, and verify rejected products
Make release decisions and manage supplier relationships
Support Quality Assurance operations and ensure compliance with current Good Manufacturing Practices (cGMP), International Organization for Standardization (ISO) standards, and other regulations
Maintain rigorous quality control and foster a continuous improvement culture
Troubleshoot complex issues with a deep understanding of quality systems, regulatory requirements, and laboratory operations
Collaborate with cross-functional teams to integrate quality control results into the manufacturing process, driving problem-solving and innovation
Ensure all associates adhere to Good Manufacturing Practices (GxP) regulations by following Standard Operating Procedures (SOPs), maintaining accurate documentation, and completing required training
Contribute to the overall compliance of the organization and commit to continuous improvement
All associates must adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training.
Associates are responsible for meeting their individual job requirements and contributing to the overall compliance of the organization.
Compliance with regulatory requirements and a commitment to continuous improvement are essential to our operations.