Global Quality Systems Leader – Compliance & QMS Excellence

CooperSurgical; Trumbull (CT); On-site; USD 140,000 - 190,000; Full time

Job summary

CooperSurgical seeks a Senior Manager, Global Quality Systems to lead governance, metrics, and continuous improvement of the global Quality Management System. You will oversee management reviews, regulatory intelligence, and QMS integration for acquisitions, ensuring alignment with FDA, ISO, MDSAP, and EU MDR requirements.

You will partner with Quality, Regulatory Affairs, Operations, R&D, Supply Chain, IT, and others to drive inspection readiness, risk mitigation, and QMS performance across a

Qualifications

• 8+ years of experience in quality management systems within a regulated medtech environment.
• 7+ years of people leadership and team development.
• Experience managing quality systems with ISO 13485, FDA 21 CFR Part 820, MDSAP, and EU MDR requirements.
• Bachelor’s degree in a relevant field; ASQ certification is a plus.

Responsibilities

• Lead the governance, effectiveness, and continuous improvement of the global QMS.
• Drive harmonization and compliance across global quality system processes.
• Identify and mitigate quality system risks while ensuring inspection readiness.
• Lead the Management Review program and drive continuous improvement.
• Develop and track quality KPIs, dashboards, and executive reporting.
• Support regulatory inspections, audits, and remediation activities as needed.

Skills

MasterControl

Veeva

TrackWise

People leadership

Regulatory knowledge

Communication

Cross-functional collaboration

Education

Bachelor's degree in Engineering/Quality

Job description

CooperSurgical seeks a Senior Manager, Global Quality Systems to lead governance, metrics, and continuous improvement of the global Quality Management System. You will oversee management reviews, regulatory intelligence, and QMS integration for acquisitions, ensuring alignment with FDA, ISO, MDSAP, and EU MDR requirements.

You will partner with Quality, Regulatory Affairs, Operations, R&D, Supply Chain, IT, and others to drive inspection readiness, risk mitigation, and QMS performance across a