Global QA Manufacturing Leader - Regulatory & Growth

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

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP in Northfield, Illinois seeks a strategic QA leader to oversee and direct quality assurance across assigned divisions. The role ensures proper controls, staff qualifications, and compliance with US FDA, EU MDR and other cGMP requirements, while delivering outstanding service to customers.

The incumbent will mentor staff, coordinate with Corporate Quality and division leaders, manage new product development quality efforts and supplier qualification, and travel as needed

Qualifications

• Bachelor’s degree.
• At least 7 years of QA related experience in a business environment.
• At least 5 years of experience managing people, including hiring, developing, motivating and directing people as they work.
• Knowledge of Quality Assurance practices in regulated industry (Device, Pharma, Personal Care or Food).

Responsibilities

• Oversee, lead and set strategic direction for the assigned divisions’ QA functions.
• Work with and coordinate with Corporate Quality as well as with division leadership to assure adherence to US FDA, EU MDR and other applicable requirements/cGMP’s.
• Develop and mentor staff through on-boarding, open communication, training and development opportunities and performance management processes; build and maintain employee morale and motivation; ensure the team is appropriately staffed with required competencies.
• Facilitate communication between Quality Assurance Directors, Managers and Specialists and their respective divisional personnel.
• Direct quality efforts for new product development, new supplier qualification.
• Assure appropriate communication between all related functions, assure project timelines and objectives are met.
• Develop training programs, approve process and procedural changes.
• Ensure proper systems are in place to facilitate a smooth and efficient process for new products and services.
• Assure all internal and external customers receive outstanding service from the department.
• Travel as necessary to facilitate communications with external customers and vendors. (10% travel minimum)

Skills

QA management

Regulated industry QA

Computer skills

Education

Bachelor’s degree

Job description

Medline Industries, LP in Northfield, Illinois seeks a strategic QA leader to oversee and direct quality assurance across assigned divisions. The role ensures proper controls, staff qualifications, and compliance with US FDA, EU MDR and other cGMP requirements, while delivering outstanding service to customers.

The incumbent will mentor staff, coordinate with Corporate Quality and division leaders, manage new product development quality efforts and supplier qualification, and travel as needed