Quality Lead, Global QS NC & CAPA Process Owner

About the role

We are seeking a Quality Lead to own the global Nonconformance (NC) and Corrective and Preventive Action (CAPA) processes for CooperVision. The role provides strategic oversight, governance, and continuous improvement of these quality systems across all sites.

Key responsibilities

• Serve as the Global Process Owner for NC and CAPA, ensuring effectiveness, compliance, and continuous improvement.
• Develop, maintain, and enhance global procedures, standards, workflows, templates, and governance documentation.
• Monitor performance metrics, investigation quality, and CAPA effectiveness, driving data‑driven decision making.
• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, EU MDR, MDSAP and other applicable regulations.
• Lead periodic process reviews, assess efficiency, and align processes with business needs.
• Define and maintain RACI models, process maps, and global ownership documentation.
• Support inspection readiness and overall quality system maturity.

Required profile

• Proven experience in quality management systems within a regulated, global manufacturing environment.
• Strong understanding of NC and CAPA processes and regulatory requirements (FDA, ISO, EU MDR, MDSAP).
• Ability to lead cross‑functional stakeholder engagement and drive continuous improvement.
• Excellent analytical and root‑cause investigation skills.

Required skills