Director of Product Quality & Compliance

Medline; Chicago (IL); On-site; USD 154,000 - 231,000; Full time

Job summary

Medline is seeking a senior Quality leader to provide direction to Quality teams, developing strategy and translating it into functional plans for long‑term goals. You will drive quality and compliance across assigned departments and work with Senior Leadership to ensure on‑time delivery and customer satisfaction.

The role requires a Bachelor’s degree in a technical field, 7+ years in medical device/drug product quality, and 4+ years in management.

Qualifications

• Bachelor’s degree in Engineering, Science, or Technical Field.
• 7+ years experience in medical device or drug product platforms, design controls, risk management and regulated industries.
• At least 4 years of management experience.
• Knowledge of 21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR.
• Advanced Excel skills (pivot tables, data analysis).

Responsibilities

• Lead Quality team(s) and set long-term goals and strategy.
• Direct development of product specifications, testing requirements, and methods for Medline branded products.
• Collaborate with Supplier Audit and Divisions to optimize supplier relationships.
• Implement QA programs and ensure compliance via audits (FDA/ISO).
• Prepare and deliver customer presentations to stakeholders.
• Oversee budgets, staffing, and multi-department coordination.

Skills

Quality leadership

Regulatory compliance

Data analysis

Excel

Project management

Education

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

Job description

Medline is seeking a senior Quality leader to provide direction to Quality teams, developing strategy and translating it into functional plans for long‑term goals. You will drive quality and compliance across assigned departments and work with Senior Leadership to ensure on‑time delivery and customer satisfaction.

The role requires a Bachelor’s degree in a technical field, 7+ years in medical device/drug product quality, and 4+ years in management.