Quality QA Specialist - Documentation & Compliance

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

Job summary

Medline Industries, LP seeks a Quality Specialist focused on a subsection of our Quality Management System such as device master records, customer complaints, product holds, recalls, or incoming quality. You will help build and maintain quality documentation and processes including specifications, tolerances, drawings, inspection criteria, testing reports, and ERP data analysis.

You will collaborate with cross-functional teams to ensure FDA/ISO compliance, track progress, review documentation

Qualifications

• Bachelor’s degree in Engineering, Science, Math or related field.
• At least 2 years of experience in Quality.
• Proficient in MS Office with Excel (intermediate).
• Knowledge of 21 CFR 820 and ISO 13485.

Responsibilities

• Assist in developing and implementing processes, reports, data analysis and procedures within the defined area of specialization.
• Collaborate with multiple groups to ensure FDA/ISO compliance and internal requirements.
• Facilitate meetings with global units to manage project requirements and deadlines.
• Track and report progress to management and ensure documentation completeness and accuracy.
• Review related documentation and analyses to certify specifications are met and suggest improvements.

Skills

Time management

MS Office

Excel

Quality assurance

Education

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

Job description

Medline Industries, LP seeks a Quality Specialist focused on a subsection of our Quality Management System such as device master records, customer complaints, product holds, recalls, or incoming quality. You will help build and maintain quality documentation and processes including specifications, tolerances, drawings, inspection criteria, testing reports, and ERP data analysis.

You will collaborate with cross-functional teams to ensure FDA/ISO compliance, track progress, review documentation