Quality Documentation Specialist – Compliance & Analysis

Medline; 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 seeks a Quality professional focused on select areas of the Quality Management System. You will help build and maintain product specifications, tolerances, drawings, testing reports, and related documentation.

The role requires collaboration with internal and external groups, knowledge of FDA/ISO standards, data analysis, and ensuring regulatory compliance; up to 10% travel may be required.

Qualifications

• MS Office Suite (Word, Excel, PowerPoint, Outlook) with intermediate Excel
• Experience developing ways of accomplishing goals with little supervision
• Experience in analyzing data and drawing concise conclusions
• Working knowledge of government and industry quality assurance standards (21 CFR 820, ISO 13485)

Responsibilities

• Assist in developing and implementing processes, reports, data analyses, and procedures within the defined area of specialization.
• Collaborate with multiple groups (internal and external) to solve problems and ensure FDA/ISO compliance.
• Facilitate meetings with global business units, sales, marketing, and branch personnel to manage requirements and deadlines.
• Review all related documentation for completeness, accuracy, and ensure products and reports meet specifications.
• Make recommendations based on analysis to improve quality standards and customer experience.

Skills

MS Office Suite (Excel)

Time management

Documentation & analysis

Quality systems knowledge (21 CFR 820,

ISO 13485

Self-motivation & supervision

Cross-functional collaboration

Education

Bachelor's degree in Engineering, Science, Math or related field

Job description

Medline Industries, LP in Mundelein, IL seeks a Quality professional focused on select areas of the Quality Management System. You will help build and maintain product specifications, tolerances, drawings, testing reports, and related documentation.

The role requires collaboration with internal and external groups, knowledge of FDA/ISO standards, data analysis, and ensuring regulatory compliance; up to 10% travel may be required.