QA & Regulatory Compliance Manager - Med Devices

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

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP in the United States seeks a Quality & Regulatory Leader to manage quality and compliance for assigned product lines. You will adapt plans to resource and operational challenges and liaise with divisions, suppliers, and manufacturing to ensure quality products and customer satisfaction.

You will drive investigations, continuous improvement projects, and design/validation planning to ensure compliance with QSR, GMP, and ISO standards across regions.

Qualifications

• Bachelor's degree in engineering, science, or technical field, or relevant experience.
• 4+ years in design/operation of medical device or drug combination product platforms with quality/regulatory exposure.
• Knowledge of 21CFR 820, ISO 13485, ISO 14971, MDSAP, MDR and related standards.

Responsibilities

• Ensure quality and regulatory compliance (QSR, GMP, ISO) across product lifecycle and regions.
• Liaise with divisions, suppliers, manufacturing, and operations to ensure quality and customer satisfaction.
• Lead investigations of complaints and drive corrective actions and improvements.
• Identify and manage execution of continuous improvement projects.
• Assist in product evaluation from QA/regulatory perspectives and plan design/testing/validation activities.
• Resolve quality issues to achieve customer satisfaction and timely resolution.
• Oversee staff and budgets as applicable, and enforce organizational policies.

Skills

Regulatory compliance knowledge

Data analysis

Project management

Advanced Excel

Travel up to 25%

Education

Bachelor's degree in Engineering/Science

Job description

Medline Industries, LP in the United States seeks a Quality & Regulatory Leader to manage quality and compliance for assigned product lines. You will adapt plans to resource and operational challenges and liaise with divisions, suppliers, and manufacturing to ensure quality products and customer satisfaction.

You will drive investigations, continuous improvement projects, and design/validation planning to ensure compliance with QSR, GMP, and ISO standards across regions.