Strategic Leader, Product Quality & Compliance

Medline Industries, Inc.; Northfield (MN); On-site; USD 154,000 - 231,000; Full time

Benefits offered by this job

Health insurance

Life and disability insurance

401(k) contributions

Paid time off

Employee Assistance Program

Job summary

Medline Industries, LP seeks a senior Quality leader to provide direction for Quality teams, ensuring compliance with regulatory standards for assigned products and processes. You will translate strategy into concrete plans and guide long-term execution.

The role involves directing QA programs, collaborating with suppliers and product managers, and managing multiple departments with a focus on quality, on-time delivery, and customer satisfaction.

Qualifications

• Bachelor’s degree in Engineering, Science, or Technical Field.
• 7+ years in medical device or drug product platforms with design controls and regulatory compliance.
• 4+ years of management experience.
• Deep knowledge of 21 CFR 820, ISO 13485, ISO 14971, MDSAP, MDR.
• Strong data analysis and reporting to drive improvements.
• Excel proficiency including pivot tables and data analysis.

Responsibilities

• Direct development of product specifications for Medline branded products, including testing requirements and qualification methods.
• Partner with Supplier Audit and Division to optimize supplier relationships.
• Develop and implement QA strategy based on Quarterly Management Review.
• Prepare and deliver customer presentations.
• Coordinate with Senior Leadership, suppliers, manufacturing, and operations to ensure quality and on-time delivery.

Skills

Regulatory knowledge

Data analysis

Project management

Advanced Excel

Travel up to 30%

Education

Bachelor's degree in Engineering/Science/Technical Field

Job description

Medline Industries, LP seeks a senior Quality leader to provide direction for Quality teams, ensuring compliance with regulatory standards for assigned products and processes. You will translate strategy into concrete plans and guide long-term execution.

The role involves directing QA programs, collaborating with suppliers and product managers, and managing multiple departments with a focus on quality, on-time delivery, and customer satisfaction.