CAPA Coordinator

Job Description

Job Title : CAPA Coordinator

Location : Gurnee, IL

Hire Type : Open-Ended Contract, In-Office

Target Pay Rate : $25.00 – $30.00 / hour (W2)

Work Schedule : Monday–Friday, 8 : 00 a.m.–5 : 00 p.m.

Overview :

Sterling has helped build careers for thousands of professionals like yourself. Our expert recruiters support you at every step in the process and as a Best of Staffing company, Sterling provides exciting work with exceptional employers across the U.S. As a contract employee of Sterling, you are eligible to receive a Full Employee Benefits Package that includes paid time off, paid holidays, 3 medical plans to choose from, dental & vision plans, 401(k), and an Employee Stock Ownership (ESOP) plan.

Job Summary :

The CAPA (Corrective and Preventive Action) Coordinator is responsible for managing and monitoring the quality management system to ensure nonconformities, issues, and customer complaints are effectively investigated, documented, and resolved. This role supports compliance with FDA QSR and ISO 13485 standards while driving continuous improvement initiatives.

Job Duties :

• Manage daily CAPA program activities and track CAPAs to completion.
• Facilitate root cause investigations using tools such as 5 Whys, Ishikawa diagrams, and process mapping.
• Maintain CAPA database, generate reports, and track metrics for management review.
• Analyze CAPA data to identify trends and recommend process improvements.
• Coordinate CAPA meetings and collaborate with cross-functional teams to ensure timely resolution.
• Ensure CAPA documentation is complete, audit-ready, and regulatory compliant.

Qualifications :