Quality & Regulatory Lead — Medical Devices

Medline Industries, Inc. in; Northfield Township (IL); On-site; USD 116,000 - 174,000; Full time

Benefits offered by this job

Health insurance

Life and disability

401(k) contributions

Paid time off

Job summary

Medline Industries, LP is seeking a Quality & Regulatory Compliance professional to manage product quality and regulatory adherence across assigned departments. The role requires collaboration with divisions, suppliers, manufacturing, and operations to ensure high-quality, compliant products and customer satisfaction.

Responsibilities include handling complaints, driving continuous improvement, and planning design/testing/validations.

Qualifications

• Bachelor’s degree in Engineering, Science, or Technical Field.
• At least 4 years of experience related to the design/operation of medical device or drug combination product platforms, design controls, risk management.
• Broad technical knowledge of relevant standards and regulations (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR).

Responsibilities

• Ensure quality and regulatory compliance with applicable regulations (ex. QSR, GMP, ISO) pertaining to the product lifecycle and regions of distribution.
• Liaise with Divisions, Suppliers, Manufacturing, and Operations to ensure quality products and customer satisfaction.
• Manage complaints and develop new approaches to solve problems identified during investigations.
• Identify and manage execution of continuous improvement projects.
• Assist in planning design, testing, inspection, and process validations to assure quality products or components.

Skills

Regulatory compliance

Data analysis

Project coordination

Excel advanced

Education

Bachelor’s degree in Engineering, Science, or Technical Field

Job description

Medline Industries, LP is seeking a Quality & Regulatory Compliance professional to manage product quality and regulatory adherence across assigned departments. The role requires collaboration with divisions, suppliers, manufacturing, and operations to ensure high-quality, compliant products and customer satisfaction.

Responsibilities include handling complaints, driving continuous improvement, and planning design/testing/validations.