Quality Systems & Compliance Leader – Global Projects

Medline Industries, LP; United States; A distancia; USD 116.000 - 174.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

401(k) contributions

Paid time off

Descripción de la vacante

Medline Industries, LP is seeking a seasoned Quality leader to drive strategic quality initiatives across the organization. You will guide cross‑functional teams, lead regulatory compliance efforts, and optimize the Quality Management System to ensure robust product quality and manufacturing efficiency.

The role requires strong experience in pharmaceutical/medical device quality, risk management, and data‑driven decision making.

Formación

• 7+ years in pharmaceutical manufacturing or medical device quality.
• Strong knowledge of ICH Q10, FDA cGMP, EU GMP is preferred.
• Experience leading quality systems like CAPA, Deviations, Change Control, Audits, Management Review.

Responsabilidades

• Lead quality projects across the organization and present outcomes to leadership.
• Identify and drive improvements to the Quality Management System for efficiency and compliance.
• Lead root cause analyses and implement corrective/preventive actions with proper documentation.
• Evaluate Cost of Quality metrics and propose cost-saving projects.
• Provide process guidance across manufacturing and corporate functions.
• Apply risk management tools (FMEA, fault tree analysis) to identify and mitigate risks.
• Maintain the Management Review program in line with ICH Q10 and site procedures.
• Coordinate data collection and analyses for PQS performance, deviations, CAPAs, audits, and changes.
• Prepare management review reports and dashboards to identify trends and risks.
• Support inspection readiness with defensible records and executive oversight.
• Escalate significant quality and regulatory risks to site and leadership.

Conocimientos

Leadership

QMS

Regulatory compliance

Risk management

Cross-functional collaboration

Data analysis

Project management

Executive communication

Educación

Bachelor’s degree in engineering or related science

Descripción del empleo

Medline Industries, LP is seeking a seasoned Quality leader to drive strategic quality initiatives across the organization. You will guide cross‑functional teams, lead regulatory compliance efforts, and optimize the Quality Management System to ensure robust product quality and manufacturing efficiency.

The role requires strong experience in pharmaceutical/medical device quality, risk management, and data‑driven decision making.