Quality & Compliance Manager – Medical Devices

Medline Industries, LP; Northfield (MN); 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 is seeking a Quality & Regulatory Compliance Leader to oversee quality programs across assigned departments. You will adapt plans to meet resource and operational challenges while ensuring compliance with QSR, GMP and ISO standards.

The role requires collaboration with divisions, suppliers, manufacturing, and operations, plus experience solving complaints and driving process improvements. Travel up to 25% is anticipated.

Qualifications

• Bachelor’s degree in engineering, science, or technical field required.
• 4+ years of design/operation experience with regulated medical devices or drug products.
• Strong knowledge of QSR, GMP, ISO regulations and risk management.
• Proficient in data analysis and Excel pivot tables.

Responsibilities

• Ensure quality and regulatory compliance with applicable regulations (QSR, GMP, ISO).
• Liaise with divisions, suppliers, manufacturing, and operations to ensure quality and customer satisfaction.
• Manage complaints and develop corrective actions from investigations.
• Lead continuous improvement projects and coordinate concurrent initiatives.
• Assist in planning design, testing, inspections, and process validations.

Skills

Regulatory compliance

QSR GMP ISO

Data analysis

Advanced Excel

Education

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

Tools

Excel

Regulatory databases

Job description

Medline Industries, LP is seeking a Quality & Regulatory Compliance Leader to oversee quality programs across assigned departments. You will adapt plans to meet resource and operational challenges while ensuring compliance with QSR, GMP and ISO standards.

The role requires collaboration with divisions, suppliers, manufacturing, and operations, plus experience solving complaints and driving process improvements. Travel up to 25% is anticipated.