Senior Director, Quality & Manufacturing (Med Device)

Medline Industries, LP; Mundelein (IL); 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 in Mundelein, IL, seeks a senior leader to direct the Quality team(s) and ensure compliance for the applicable products and processes. You will translate strategy into functional plans and guide execution of long-term goals.

The role requires extensive experience in QSR/GMP/ISO, collaboration with divisions, suppliers, and manufacturing, and a track record of improving quality and on-time delivery.

Qualifications

• Bachelor’s degree in Engineering, Science or a technical field.
• 7+ years in design/operation of medical device or drug products with QA focus.
• 4+ years of management experience in regulated environments.

Responsibilities

• Direct development of product specs, 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.
• Liaise with senior leadership to ensure quality, on-time delivery, and customer satisfaction.
• Collaborate with suppliers, manufacturers and product managers on QA programs.
• Oversee QSR and ensure compliance with FDA/ISO/internal audits.
• Manage departments, budget, policies and staffing decisions.

Skills

Technical standards

Data analysis

Project coordination

Advanced Excel

Travel 30%

Education

Bachelor’s degree in Engineering/Science/Technical Field

Job description

Medline Industries, LP in Mundelein, IL, seeks a senior leader to direct the Quality team(s) and ensure compliance for the applicable products and processes. You will translate strategy into functional plans and guide execution of long-term goals.

The role requires extensive experience in QSR/GMP/ISO, collaboration with divisions, suppliers, and manufacturing, and a track record of improving quality and on-time delivery.