Inspection-Readiness Quality Leader

Medline Industries, Inc. in; Northfield Township (IL); On-site; USD 134,000 - 201,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP is seeking a Senior Quality Manager for Inspection Readiness & Response Management (Project Management). The role leads quality/compliance across products and regions, coordinates with divisions and suppliers, and shapes policies to ensure readiness for FDA/EMA/ISO inspections.

The position requires extensive regulatory knowledge, leadership, and the ability to manage multiple projects with up to 30% travel.

Qualifications

• Bachelor's degree in Engineering, Science, or Technical Field or equivalent experience.
• 5+ years of experience in medical device or regulated industry.
• 2+ years of management experience.
• Knowledge of 21 CFR 820, ISO 13485, ISO 14971, MDSAP, MDR.
• Advanced Excel skills for data analysis and reporting.

Responsibilities

• Monitor and ensure compliance with QSR, GMP, ISO across products and regions.
• Lead investigations and coordinate cross-functional teams.
• Develop and implement inspection readiness program and prepare for regulatory audits.
• Drive continuous improvement and policy development.
• Oversee inspection responses and CAPA execution.

Skills

Regulatory knowledge

Project management

Data analysis

Leadership

Travel up to 30%

Education

Bachelor's degree in Engineering/Science/Technical Field

Tools

Microsoft Excel

Job description

Medline Industries, LP is seeking a Senior Quality Manager for Inspection Readiness & Response Management (Project Management). The role leads quality/compliance across products and regions, coordinates with divisions and suppliers, and shapes policies to ensure readiness for FDA/EMA/ISO inspections.

The position requires extensive regulatory knowledge, leadership, and the ability to manage multiple projects with up to 30% travel.