Head of Manufacturing Quality & Compliance

Medline; Northfield Township (IL); On-site; USD 234,000 - 351,000; Full time

Job summary

Medline Industries seeks a QA leader to oversee and direct the Quality Assurance functions for assigned divisions, ensuring proper controls, capable staff, and compliance with US FDA, EU MDR and cGMP requirements. You will mentor staff, coordinate with corporate QA and division leadership, and drive quality for new products and suppliers.

The role requires at least 7 years in QA and 5 years in people management, with awareness of regulated industries and the ability to travel up to 20% for

Qualifications

• 7+ years of QA-related experience in a business environment.
• 5+ years of experience managing people, including hiring, developing, motivating and directing staff.
• Willing to travel up to 20% of the time.
• Knowledge of QA practices in regulated industries (Device, Pharma, Personal Care or Food).
• Intermediate skill level in relevant computer programs.

Responsibilities

• Oversee, lead and set strategic direction for the assigned divisions’ QA functions.
• Coordinate with Corporate Quality and division leadership to ensure FDA, EU MDR and cGMP compliance.
• Develop and mentor staff through onboarding, training, and performance management.
• Facilitate communication between QA Directors, Managers, and Specialists and their divisional personnel.
• Direct quality efforts for new product development and supplier qualification.
• Develop training programs and approve process and procedural changes.
• Ensure systems support smooth product/service launches and communicate with customers and vendors (20% travel).

Skills

Quality Assurance leadership

People management

Regulatory knowledge

Project coordination

Education

Bachelor's degree

Job description

Medline Industries seeks a QA leader to oversee and direct the Quality Assurance functions for assigned divisions, ensuring proper controls, capable staff, and compliance with US FDA, EU MDR and cGMP requirements. You will mentor staff, coordinate with corporate QA and division leadership, and drive quality for new products and suppliers.

The role requires at least 7 years in QA and 5 years in people management, with awareness of regulated industries and the ability to travel up to 20% for