Associate I - Complaints

Alcon Research•Irvine, CA

7d•$71,400 - $92,400•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 Associate I, Complaints is primarily responsible for processing and investigating complaints, ensuring compliance with regulatory requirements, and supporting project goals at our Manufacturing Facility in Irvine, CA. 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.

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

Process, investigate, and monitor trending and reporting of product defect complaints, serving as the primary contact.
Align with Medical Safety and/or Research and Development on adverse events.
Address and expedite product complaints under the company's complaint policy and procedures.
Ensure compliance with regulatory agencies' reporting requirements.
Follow procedures with some decision-making authority, requiring job-related training, attention to detail, and reliability.
Support complaint activity monitoring and provide suggestions to modify existing manufacturing or packaging processes.
Maintain unified product defect investigation operating procedures.
Collaborate with cross-functional teams to drive problem-solving and innovation through scientific principles.
Maintain accurate and complete documentation and ensure rigorous quality control.
Complete all required training and meet individual job requirements to contribute to the overall compliance of the organization.
Commit to continuous improvement in operations.