Senior Quality & Regulatory Compliance Leader

Medline Industries, Inc.; Northfield (MN); On-site; USD 134,000 - 201,000; Full time

Benefits offered by this job

Health insurance

Life and disability insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP is seeking a seasoned Quality Assurance and Compliance leader to oversee product quality, regulatory readiness, and process improvements across assigned departments. You will drive investigations, CAPA execution, and policy implementation with cross-functional teams.

The role requires 5+ years in regulated environments (medical devices/pharma), 2+ years of management, and strong expertise in QSR/GMP/ISO standards. Travel up to 30% is expected as part of the role.

Qualifications

• Bachelor’s degree in Engineering, Science, or a technical field.
• 5+ years in design/operation of medical device or drug product platforms.
• 2+ years of management experience.
• Strong knowledge of QSR/GMP/ISO standards.
• Travel up to 30% for business purposes.

Responsibilities

• Monitor and maintain compliance with QSR, GMP, ISO for life cycle and distribution regions.
• Lead investigations and drive CAPA with cross-functional teams.
• Develop and implement communication strategies with executives and stakeholders.
• Oversee quality issues resolution and readiness for regulatory audits.
• Lead inspection preparation, risk evaluations, and readiness activities.
• Collaborate with Quality, Manufacturing, Regulatory Affairs, and Operations to mitigate compliance risks.

Skills

Quality management

Regulatory compliance

Leadership

Risk management

Education

Bachelor's degree in Engineering/Science/Technical field

Tools

Microsoft Excel

Job description

Medline Industries, LP is seeking a seasoned Quality Assurance and Compliance leader to oversee product quality, regulatory readiness, and process improvements across assigned departments. You will drive investigations, CAPA execution, and policy implementation with cross-functional teams.

The role requires 5+ years in regulated environments (medical devices/pharma), 2+ years of management, and strong expertise in QSR/GMP/ISO standards. Travel up to 30% is expected as part of the role.