Associate I, Complaints
Alcon
Summary
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.
Job description
The Associate I, Complaints is primarily responsible for processing and investigating product complaints, supporting project goals, and ensuring compliance with regulatory requirements through accurate documentation and collaboration at our site in Irvine, CA.
Specifics Include:
- Apply specialized knowledge to complete tasks and achieve objectives in the Complaints discipline.
- Serve as the primary contact to process, investigate, and monitor trending and reporting of product defect complaints, addressing and expediting them in alignment with company policy and procedures.
- Collaborate with Medical Safety and Research and Development teams on adverse events.
- Ensure compliance with regulatory agencies' reporting requirements and adhere to Good Practice (GxP) regulations by strictly following Standard Operating Procedures.
- Support complaint activity monitoring, provide suggestions to modify existing manufacturing or packaging processes, and maintain unified product defect investigation operating procedures.
- Collaborate with cross-functional teams to drive problem-solving and innovation using scientific principles.
- Maintain accurate and complete documentation, ensure rigorous quality control, and complete all required training to meet individual job requirements.
- Contribute to the overall compliance of the organization and support continuous improvement.
What You'll Bring to Alcon:
- 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
- Location: Onsite
- Travel Requirements: Up to 10%
- Relocation Assistance: None
- Sponsorship Available: No
Requirements
- Bachelor's degree or equivalent years of directly related experience (or high school +8 yrs; Assoc. +4 yrs)
- Ability to fluently read, write, understand and communicate in English
- Onsite work in Irvine, CA
- Travel up to 10%
Benefits
- Health Insurance
- Life Insurance
- Retirement Planning
- Flexible Time Off
- Paid Time Off
Company overview
Alcon Inc. is the global leader in eye care, dedicated to helping people see brilliantly. Founded in 1945 as a small pharmacy in Fort Worth, Texas, the company has grown into the world's largest eye care device company with complementary businesses in Surgical and Vision Care. As a Swiss-American multinational corporation headquartered in Geneva, Switzerland with major operations in Fort Worth, Texas, Alcon operates in 60 countries and serves patients in over 140 countries. The company's Surgical segment focuses on ophthalmic products for cataract surgery, vitreoretinal surgery, refractive laser surgery, and glaucoma surgery, including implantables, consumables, and surgical equipment. The Vision Care segment comprises daily disposable, reusable, and color-enhancing contact lenses, along with a comprehensive portfolio of ocular health products for dry eye, contact lens care, and ocular allergies. With over 75 years of heritage, Alcon has a long history of industry firsts and makes substantial annual investments in research and development to meet evolving customer needs and advance patient care. The company became an independent publicly-traded entity in 2019 after spinning off from Novartis.