Global NC & CAPA Quality Lead | Process Excellence

CooperVision Limited; Juana Díaz (PR); On-site; USD 130,000 - 170,000; Full time

Job summary

CooperVision is seeking a Quality Lead, Global QS NC & CAPA Process Owner to provide strategic oversight, governance, and continuous improvement of the enterprise Nonconformance (NC) and CAPA processes across the organization.

You will drive standardization, regulatory compliance, and data-driven decision making across global sites, enabling effective identification, investigation, correction, and prevention of quality issues.

Qualifications

• Experience leading NC & CAPA programs
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485
• Ability to drive global process standardization and audits

Responsibilities

• Serve as Global Process Owner for NC & CAPA
• Maintain governance, templates, and workflows
• Ensure regulatory compliance across sites
• Lead internal and external audits and inspections
• Drive CAPA effectiveness and investigation quality
• Collaborate with IT to optimize eQMS platform

Skills

Quality management

CAPA leadership

Regulatory compliance

Root cause analysis

Process ownership

Cross-functional collaboration

Education

Bachelor's degree in quality/engineering

ISO 13485 training

Tools

eQMS

Job description

CooperVision is seeking a Quality Lead, Global QS NC & CAPA Process Owner to provide strategic oversight, governance, and continuous improvement of the enterprise Nonconformance (NC) and CAPA processes across the organization.

You will drive standardization, regulatory compliance, and data-driven decision making across global sites, enabling effective identification, investigation, correction, and prevention of quality issues.