Quality Assurance Leader, Manufacturing & Compliance

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

Benefits offered by this job

Bonus eligible

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP seeks a seasoned Quality Assurance leader to oversee QA functions across divisions, ensuring proper controls, qualified staff, and compliance with US FDA, EU MDR and cGMP standards.

The role directs QA for new product development, supplier qualification and training. It requires effective communication with Quality Directors, Managers and divisional teams and may involve up to 20% travel.

Qualifications

• 7+ years of QA related experience in a business environment.
• 5+ years of experience managing people, including hiring, developing, motivating and directing people.
• 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 compliance with US FDA, EU MDR and other cGMP requirements.
• Develop and mentor staff through onboarding, training and performance management processes.
• Direct quality efforts for new product development and supplier qualification; ensure timely project timelines and objectives.
• Develop training programs and approve process and procedural changes.
• Ensure systems are in place to facilitate smooth processes for new products and services.
• Travel as necessary to communicate with external customers and vendors (20% travel).

Skills

QA leadership

Regulatory compliance

Travel readiness

Computer proficiency

Education

Bachelor's degree

Tools

MS Office

Job description

Medline Industries, LP seeks a seasoned Quality Assurance leader to oversee QA functions across divisions, ensuring proper controls, qualified staff, and compliance with US FDA, EU MDR and cGMP standards.

The role directs QA for new product development, supplier qualification and training. It requires effective communication with Quality Directors, Managers and divisional teams and may involve up to 20% travel.