QA Risk & Compliance Leader — Medical Devices

Medline; Chicago (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 is seeking a Quality and Regulatory leader in the Chicago area to oversee quality and regulatory compliance for assigned products and processes across lifecycle and distribution regions.

You will adapt departmental plans to address resource and operational challenges, collaborating with divisions, suppliers, manufacturing, and operations to ensure quality and customer satisfaction. Travel up to 25% may be required.

Qualifications

• Bachelor’s degree in Engineering, Science, or Technical Field, or relevant experience.
• At least 4 years of experience in medical device or drug combination product design/operation with design controls and risk management.
• Knowledge of QSR, GMP, ISO (21CFR 820, ISO 13485, ISO 14971, MDSAP, MDR).
• Advanced Excel skills and ability to analyze data to drive improvements.

Responsibilities

• Ensure quality and regulatory compliance across lifecycle and regions.
• Act as liaison with divisions, suppliers, manufacturing, and operations to ensure quality and customer satisfaction.
• Manage complaints and drive investigations to develop corrective actions.
• Identify and manage execution of continuous improvement projects.
• Assist in planning design, testing, inspection, and process validations to assure quality.
• Resolve quality issues to customer satisfaction in a timely manner.

Skills

Regulatory compliance

Excel proficiency

Project coordination

Education

Bachelor’s degree in Engineering/Science/Technical Field

Job description

Medline Industries, LP is seeking a Quality and Regulatory leader in the Chicago area to oversee quality and regulatory compliance for assigned products and processes across lifecycle and distribution regions.

You will adapt departmental plans to address resource and operational challenges, collaborating with divisions, suppliers, manufacturing, and operations to ensure quality and customer satisfaction. Travel up to 25% may be required.