Lead Quality Engineer, QMS & Compliance (Pharma)

Medline Industries, Inc.; Northfield (MN); On-site; USD 116,000 - 174,000; Full time

Job summary

Medline Industries, LP in Minnesota seeks a senior quality leader to drive and manage quality projects across the organization, collaborating with cross‑functional teams and serving as a subject matter expert to ensure compliance with applicable regulations and standards; support strategic initiatives to improve our global quality system and provide emergency support when challenges arise.

This role bridges conceptual design and practical manufacturing, contributing to cost‑effective production

Qualifications

• Bachelor's degree required.
• 7+ years of experience in pharmaceutical manufacturing or quality assurance preferred.
• Travel up to 30% for business purposes (domestic and international).

Responsibilities

• Lead quality projects across the organization and present deliverables to leadership; train affected groups on changes.
• Identify and drive opportunities to improve the Quality Management System for efficiency and compliance.
• Lead root cause analyses and plan corrective/preventive actions for critical quality concerns with proper documentation.
• Evaluate Cost of Quality metrics and propose cost-saving projects.
• Provide process guidance for manufacturing and corporate functions; ensure cross-divisional consistency.
• Apply risk management tools (e.g., FMEA) to identify and mitigate risks; document risk activities.
• Develop and deploy enterprise cGMP best practices across Medline's pharmaceutical network.
• Design and implement training to strengthen cGMP behaviors and process controls.
• Provide technical leadership to support sustained cGMP compliance; lead investigations, deviations, CAPAs, and continuous improvement initiatives.
• Support inspection readiness and regulatory compliance across the organization.

Skills

Project leadership

Quality management

Regulatory compliance

QMS knowledge

Root cause analysis

CAPA

Risk management

Training and coaching

Cross-functional collaboration

Data analysis

Education

Bachelor's degree

Job description

Medline Industries, LP in Minnesota seeks a senior quality leader to drive and manage quality projects across the organization, collaborating with cross‑functional teams and serving as a subject matter expert to ensure compliance with applicable regulations and standards; support strategic initiatives to improve our global quality system and provide emergency support when challenges arise.

This role bridges conceptual design and practical manufacturing, contributing to cost‑effective production