Quality Lead, Global QS NC & CAPA Process Owner

At CooperVision, a division of CooperCompanies, we're driven by a unifying purpose to help people to experience life's beautiful moments.

We are connected through our shared values - dedicated, innovative, friendly, partners, and do the right thing.

As a leading global manufacturer of contact lenses, we are committed to helping improve the way people see each day.

Through our diverse lens portfolio, we tackle the toughest vision challenges - including astigmatism, presbyopia, and childhood myopia.

We offer the most complete collection of spherical, toric, and multifocal products available, enabling us to fit 99% of all contact wearers.

Learn more at www.coopervision.com .


* This position requires full-time onsite work (5 days per week) in Juana Diaz, PR and is not eligible

for relocation assistance

Job Summary:

The Quality Lead, Global QS NC & CAPA Process Owner is responsible for the strategic oversight, governance, and continuous improvement of the enterprise Nonconformance and CAPA processes.

This role ensures global process standardization, regulatory compliance, system effectiveness, and operational excellence through process ownership, performance monitoring, root cause analysis, stakeholder engagement, and digital process optimization.

The position serves as the primary authority for NC and CAPA process design and execution, driving consistent implementation across global sites while enabling effective identification, investigation, correction, and prevention of quality issues.

The role also supports inspection readiness, quality system maturity, and data-driven decision-making through effective process governance and performance management.

Essential Functions & Accountabilities:

Global Process Ownership - NC & CAPA


* Serve as the Global Process Owner for Nonconformance and CAPA processes across the enterprise Quality Management System.


* Accountable for the effectiveness, compliance, and continuous improvement of the global NC and CAPA processes, including performance metrics, investigation quality, CAPA effectiveness, and timely execution.


* Establish, maintain, and continuously improve global procedures, standards, workflows, templates, and governance requirements.


* Ensure NC and CAPA processes remain compliant with applicable regulations and standards including FDA 21 CFR Part 820, ISO 13485, EU MDR, MDSAP, and other applicable regulatory requirements by assessing documents of external origin and implementing necessary actions to maintain ongoing compliance.


* Lead periodic process reviews to assess effectiveness, compliance, efficiency, and alignment with business needs.


* Define and maintain global process ownership documentation, RACI models, and process maps.


* Ensure process harmonization and adoption across all sites, functions, and business units.

Process Governance & Compliance


* Establish process governance mechanisms, escalation pathways, decision frameworks, and ...