QA Risk & Compliance Manager (Medical Devices)

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

Benefits offered by this job

Health insurance

Life and disability insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP seeks a quality and regulatory leader to oversee compliance for assigned products and processes. You will adapt plans to address resource and operational challenges while coordinating with divisions, suppliers, and manufacturing to ensure high-quality, compliant products.

The role involves managing investigations, driving continuous improvement, and ensuring timely resolution of quality issues across life-cycle stages and distribution regions.

Qualifications

• Bachelor's degree in Engineering, Science, or Technical Field or relevant experience.
• At least 4 years of experience related to design/operation of medical device or drug products in regulated environments.
• Travel up to 25% of the time for business purposes.

Responsibilities

• Ensure quality and regulatory compliance with applicable regulations (QSR, GMP, ISO) for product life cycle and distribution regions.
• Act as liaison 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 product evaluation from a quality assurance and regulatory compliance standpoint, including design, testing, inspection, and process validations.
• Ensure all quality issues are resolved to customer satisfaction in a timely manner.
• Interface with internal and external customers to resolve product or production quality issues.

Skills

Regulatory compliance

Quality Assurance

QSR/GMP/ISO knowledge

Data analysis

Excel proficiency

Education

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

Tools

Microsoft Excel

Job description

Medline Industries, LP seeks a quality and regulatory leader to oversee compliance for assigned products and processes. You will adapt plans to address resource and operational challenges while coordinating with divisions, suppliers, and manufacturing to ensure high-quality, compliant products.

The role involves managing investigations, driving continuous improvement, and ensuring timely resolution of quality issues across life-cycle stages and distribution regions.