Senior Quality & Regulatory Manager (Medical 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 is seeking a Quality/Regulatory leader responsible for managing quality and regulatory compliance for assigned departments. The role adapts departmental plans to address resource and operational challenges to ensure product quality and customer satisfaction.

The position requires collaboration with divisions, suppliers, and manufacturing, plus oversight of complaint handling, continuous improvement, and design validation processes.

Qualifications

• Broad knowledge of 21CFR 820, ISO 13485, ISO 14971, MDSAP, MDR.
• Ability to analyze data to identify issues and drive improvements.
• Experience coordinating multiple projects with competing priorities.
• Advanced Excel skills (AVERAGE, pivot tables, formatting).
• Willingness to travel up to 25% of time for business purposes.

Responsibilities

• Ensure quality and regulatory compliance for products and processes.
• Liaise with divisions, suppliers, manufacturing, and operations to secure quality and satisfaction.
• Manage complaints and drive investigations to resolve issues.
• Lead continuous improvement projects and support QA/regulatory assessments.
• Assist in design, testing, inspection, and process validations to ensure quality.
• Resolve quality issues and communicate with customers and stakeholders.

Skills

Regulatory knowledge

Data analysis

Project coordination

Excel proficiency

Travel 25%+

Education

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

Job description

Medline Industries, LP is seeking a Quality/Regulatory leader responsible for managing quality and regulatory compliance for assigned departments. The role adapts departmental plans to address resource and operational challenges to ensure product quality and customer satisfaction.

The position requires collaboration with divisions, suppliers, and manufacturing, plus oversight of complaint handling, continuous improvement, and design validation processes.