QA Documentation Specialist — Specs & Compliance

Medline Industries, Inc.; Mundelein (IL); On-site; USD 67,000 - 101,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP in Mundelein, IL is seeking a Quality Associate to specialize in a subsection of our Quality Management System, such as device master records, customer complaints, recalls, or product holds. You will help build and maintain quality documentation, specifications, tolerances, drawings, inspection criteria and test reports while ensuring compliance with FDA/ISO standards.

The role emphasizes collaboration with internal and external teams, data analysis, and adherence to

Qualifications

• Experience implementing quality processes and documentation with minimal supervision.
• Strong data analysis, prioritization, and reporting skills.
• Familiarity with FDA/ISO 21 CFR 820 and ISO 13485 standards.

Responsibilities

• Assist in development and implementation of processes, reports, and procedures within area of specialization.
• Collaborate with internal and external groups to maintain compliance with FDA, ISO and internal requirements.
• Facilitate meetings with global units to manage project requirements and deadlines; track progress.
• Review documentation for completeness, accuracy, and conformance to specifications.
• Make recommendations based on analysis to improve quality and customer experience.

Skills

Self-motivation

Time management

MS Office

Analytical thinking

Quality standards knowledge

Travel up to 10%

Education

Bachelor’s degree in Engineering/Science/Math or related field

Tools

MS Excel

ERP systems analysis

Quality management software

Job description

Medline Industries, LP in Mundelein, IL is seeking a Quality Associate to specialize in a subsection of our Quality Management System, such as device master records, customer complaints, recalls, or product holds. You will help build and maintain quality documentation, specifications, tolerances, drawings, inspection criteria and test reports while ensuring compliance with FDA/ISO standards.

The role emphasizes collaboration with internal and external teams, data analysis, and adherence to