Director, Quality & Compliance - Medical Devices

Medline Industries, LP; United States; On-site; USD 154,000 - 231,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP is seeking a senior Quality leader to direct the Quality team(s) ensuring compliance for assigned products and processes. You will translate strategy into action, lead long-term planning, and partner with senior leadership to drive quality and customer satisfaction across Medline branded products.

You will oversee QA programs, manage multiple departments, and drive continuous improvement while aligning with FDA/ISO requirements and internal audits.

Qualifications

• Bachelor’s degree in Engineering, Science, or Technical Field.
• 7+ years of experience in medical device or drug product platforms design/operations, with QSR/GMP/ISO compliance.
• 4+ years of management experience.
• In-depth knowledge of 21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR.
• Advanced Excel skills and data analysis abilities.

Responsibilities

• Direct the development of product specifications for Medline branded products and testing methods.
• Collaborate with Supplier Audit department and Division to optimize supplier relationships.
• Lead QA strategy development and management review outputs to guide long-term goals.
• Communicate with senior leadership, suppliers, manufacturing, and operations to ensure quality, on-time delivery, and customer satisfaction.
• Oversee QA programs across assigned departments and ensure compliance with audits.

Skills

Leadership

Regulatory compliance

Quality systems

Data analysis

Excel proficiency

Project management

Communication

Education

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

Tools

Microsoft Excel

Job description

Medline Industries, LP is seeking a senior Quality leader to direct the Quality team(s) ensuring compliance for assigned products and processes. You will translate strategy into action, lead long-term planning, and partner with senior leadership to drive quality and customer satisfaction across Medline branded products.

You will oversee QA programs, manage multiple departments, and drive continuous improvement while aligning with FDA/ISO requirements and internal audits.