Senior QA Leader, Manufacturing & Regulatory Compliance

Medline Industries, LP; Northfield (MN); On-site; USD 234,000 - 351,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Life and disability

Job summary

Medline Industries, LP is seeking a Quality Assurance leader to oversee QA across divisions, ensuring proper controls, resources, and qualified staff while maintaining compliance with regulatory requirements. You will set strategic directions and collaborate with Corporate Quality and division leadership.

The role emphasizes mentoring staff, developing training, maintaining timelines for new products and supplier qualification, and ensuring excellent service to internal and external customers.

Qualifications

• 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).
• Bachelor’s degree is required.

Responsibilities

• Oversee, lead and set strategic direction for the assigned divisions’ QA functions.
• 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 leadership

People management

Computer skills

Education

Bachelor’s degree

Job description

Medline Industries, LP is seeking a Quality Assurance leader to oversee QA across divisions, ensuring proper controls, resources, and qualified staff while maintaining compliance with regulatory requirements. You will set strategic directions and collaborate with Corporate Quality and division leadership.

The role emphasizes mentoring staff, developing training, maintaining timelines for new products and supplier qualification, and ensuring excellent service to internal and external customers.