Quality Manufacturing Leader — Medical Devices & Compliance

Medline Industries, LP; Mankato (MN); On-site; USD 154,000 - 231,000; Full time

Job summary

Medline Industries, LP in Minnesota is seeking a senior Quality leader to direct the Quality team(s) and drive compliance across medical device and drug products. You will translate strategy into functional plans and guide long-term execution of quality initiatives.

You will develop QA programs, oversee audits (FDA/ISO), manage multiple departments, and partner with senior leaders, suppliers, and manufacturing to ensure on-time delivery and customer satisfaction.

Qualifications

• Bachelor’s degree in Engineering, Science, or Technical Field is required.
• At least 7 years of experience in design/operation of medical device or drug combination product platforms and related regulations (21CFR 820, ISO 13485, ISO 14971, MDSAP, MDR).
• At least 4 years of management experience.

Responsibilities

• Lead Quality team(s) to ensure product quality and regulatory compliance.
• Develop specifications and testing requirements for Medline products.
• Collaborate with suppliers, manufacturing, and product managers on QA programs.
• Oversee QSR and internal audits for compliance with FDA/ISO requirements.
• Present to customers and liaise with senior leadership.

Skills

Data analysis

Pivot tables

Excel advanced

Education

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

Tools

Microsoft Excel

Job description

Medline Industries, LP in Minnesota is seeking a senior Quality leader to direct the Quality team(s) and drive compliance across medical device and drug products. You will translate strategy into functional plans and guide long-term execution of quality initiatives.

You will develop QA programs, oversee audits (FDA/ISO), manage multiple departments, and partner with senior leaders, suppliers, and manufacturing to ensure on-time delivery and customer satisfaction.