Global Quality Systems Lead – Compliance & Continuous Improvement

CooperSurgical; Livingston (NJ); On-site; USD 120,000 - 160,000; Full time

Job summary

CooperSurgical’s Senior Manager, Global Quality Systems leads the global Quality Management System, ensuring compliance with FDA QMSR, ISO 13485, MDSAP, EU MDR and other requirements. The role oversees management review, metrics, reporting, regulatory intelligence, and merger/acquisition integration, driving governance and continuous improvement.

You will partner with cross-functional leaders, develop KPIs, support eQMS deployment, and guide quality system enhancements, inspections, and

Qualifications

• 8+ years in quality management within regulated medtech.
• 7+ years in people leadership and team development.
• Experience with ISO 13485, FDA 21 CFR Part 820, MDSAP, EU MDR.

Responsibilities

• Lead governance and continuous improvement of the global QMS.
• Develop quality system KPIs, dashboards, and reports.
• Ensure inspection readiness and regulatory readiness across functions.
• Support eQMS implementation and regulatory inspections.

Skills

MasterControl

Veeva

TrackWise

Team leadership

Regulatory compliance

Education

Bachelor’s degree in Engineering or Life Sciences

Tools

MasterControl

Veeva

TrackWise

Job description

CooperSurgical’s Senior Manager, Global Quality Systems leads the global Quality Management System, ensuring compliance with FDA QMSR, ISO 13485, MDSAP, EU MDR and other requirements. The role oversees management review, metrics, reporting, regulatory intelligence, and merger/acquisition integration, driving governance and continuous improvement.

You will partner with cross-functional leaders, develop KPIs, support eQMS deployment, and guide quality system enhancements, inspections, and