Associate I, Quality Operations

Alcon Research•Sinking Spring, PA

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 Associate I, Quality Operations is primarily responsible for applying specialized knowledge to support project goals by monitoring product quality, resolving non-conformances, and maintaining documentation. You will use advanced quality management practices and conduct independent research.

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

Bachelor’s degree in Engineering (e.g., Mechanical, Industrial, Biomedical, or related field) preferred, recent graduates are encouraged to apply
Experience with medical devices or pharmaceuticals
Knowledge of Excel, Power Point and Minitab
Strong analytical, communication, and problem‑solving skills
Ability to work collaboratively in a fast‑paced, regulated environment
Interest in quality systems, manufacturing processes, and continuous improvement

Responsibilities

Interact effectively with other facilities to support product tech transfer.
Support product validations through data collection.
Support/ execute validations, product, equipment, and manufacturing processes.
Ensure adequate product and process controls are in place for identified critical or major quality attributes/process parameters within assigned production areas.
Investigate and/or provide input on non-conformance events (NC), Corrective Actions, and Preventive Actions (CAPA) while providing guidance and approval.
Ensure supplier-related quality issues (i.e. customer complaints, non-conformances) with assigned commodities are corrected to prevent recurrence.
Partner with the supplier on the use of root cause analysis tools paired with a formal corrective action process.
Ensures immediate action, including for cause visits, is taken with suppliers on issues deemed critical.
Track and trend NC and CAPA data with guidance using various statistical and non-statistical problem-solving tools as part of the analysis.
Lead product holds and quarantine when necessary.
Assist Manufacturing, Engineering, and other Quality functions to create a presence on the production floor to support the production process.
Support and promote improvement activities for production areas.
Uses various statistical and non-statistical problem-solving tools to analyze data, issues, or improvement opportunities.
Administer validation protocols associated with product/process changes including writing the initial protocol for qualification, scheduling the logistics of the protocol run with manufacturing, product testing, and evaluation writing a final technical summary to include conclusions drawn from the test data and subsequent recommendations.