Quality & Compliance Director — MedTech Manufacturing

Medline Industries, LP; Waukegan (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 is seeking a senior Quality leader to provide direction to quality teams, ensuring product quality and regulatory compliance for assigned departments. This role develops strategy, translates it into actionable plans, and guides long-term execution to meet company goals.

The position requires extensive experience in medical device/drug-related QA, strong regulatory knowledge, and proven leadership in managing multiple departments and budgets.

Qualifications

• Bachelor’s degree in Engineering, Science, or Technical Field is typically required.
• 7+ years of experience related to design/operation of medical device or drug combination product platforms, design controls, risk management, with QSR/GMP/ISO compliance.
• 4+ years of management experience.
• Strong knowledge of 21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR; able to analyze data, identify trends, and drive improvements.

Responsibilities

• Direct development of product specifications for Medline branded products, including testing requirements and methods.
• Collaborate with Supplier Audit, Division, Manufacturing, and Operations to ensure quality and on-time delivery.
• Lead strategic planning for Quality dept. with multi-year goals and budget oversight.
• Oversee QA programs and ensure compliance through audits and continuous improvement.
• Hire, develop, and manage staff; set priorities and ensure deadlines are met.

Skills

QSR/GMP/ISO compliance knowledge

Advanced Microsoft Excel

Data analysis & reporting

Education

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

Job description

Medline Industries, LP is seeking a senior Quality leader to provide direction to quality teams, ensuring product quality and regulatory compliance for assigned departments. This role develops strategy, translates it into actionable plans, and guides long-term execution to meet company goals.

The position requires extensive experience in medical device/drug-related QA, strong regulatory knowledge, and proven leadership in managing multiple departments and budgets.