Senior Director, Manufacturing Quality

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

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Employee Assistance Program

Bonus eligible

Job summary

Medline Industries, LP is seeking an experienced Quality leader to direct the Quality teams, develop strategy, and guide execution of long-term goals for assigned departments. You will oversee QA programs, supplier relations, and compliance with QSR/GMP/ISO standards, while communicating with senior leadership and delivering customer-focused results.

The role requires 7+ years in medical device/drug platforms and 4+ years of management, with deep regulatory knowledge and strong data analysis.

Qualifications

• Bachelor's degree in Engineering, Science, or Technical Field.
• 7+ years in design/operation of medical device or drug combination product platforms with QSR/GMP/ISO compliance.
• At least 4 years of management experience.
• Deep knowledge of 21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR.
• Strong data analysis to identify issues and drive improvement.
• Ability to manage multiple projects and deadlines.
• Travel up to 30% of the time.

Responsibilities

• Direct the development of product specifications for Medline branded products and testing requirements.
• Partner with Supplier Audit department and Division to determine optimal supplier relationships.
• Develop and implement QA strategy based on Quarterly Management Review.
• Prepare and deliver customer presentations.
• Collaborate with senior leadership to ensure quality, on-time delivery and customer satisfaction.
• Work with suppliers, manufacturing partners and product managers on QA programs.
• Oversee QSR compliance and audits (FDA/ISO/internal).
• Strategic, tactical and operational planning for the function (12+ months).
• Direct budgeting for departments/projects.
• Interpret and execute policies; hire, train, and review staff.
• Manage multiple departments with system-wide accountability.

Skills

Quality leadership

Regulatory compliance

QSR/ISO/MDR knowledge

Data analysis

Strategic planning

Vendor management

Excel advanced

Education

Bachelor's degree in Engineering/Science/Technical Field

Tools

Microsoft Excel

Job description

Medline Industries, LP is seeking an experienced Quality leader to direct the Quality teams, develop strategy, and guide execution of long-term goals for assigned departments. You will oversee QA programs, supplier relations, and compliance with QSR/GMP/ISO standards, while communicating with senior leadership and delivering customer-focused results.

The role requires 7+ years in medical device/drug platforms and 4+ years of management, with deep regulatory knowledge and strong data analysis.