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 compliance monitoring activities.
• Monitor adherence to process requirements and drive remediation of identified gaps and noncompliance trends.
• Evaluate the impact of new regulatory requirements and industry best practices on NC and CAPA processes.
• Support internal audits, external audits, regulatory inspections, and management review activities related to process performance and compliance.
• Serve as the enterprise NC/CAPA Subject Matter Expert during regulatory inspections, Notified Body audits, MDSAP audits, customer audits, and certification assessments, ensuring effective process representation and inspection readiness.

eQMS Process Management

• Partner with Quality Systems and IT teams to define and maintain NC and CAPA requirements within the eQMS platform.
• Lead business process requirements, workflow design, user acceptance testing, and system enhancement activities.
• Assess opportunities for automation, digitalization, and simplification while maintaining regulatory compliance.
• Support system deployments, upgrades, and validation activities impacting NC and CAPA functionality.
• Ensure process and system alignment throughout the lifecycle of the eQMS platform.

Continuous Improvement & Process Effectiveness

• Establish and monitor global performance indicators and quality system health metrics.
• Analyze process data and trends to identify systemic issues, recurring failures, and opportunities for improvement.
• Establish and promote enterprise root cause analysis methodologies and provide coaching to ensure effective and consistent problem-solving practices across the organization.
• Drive implementation of corrective and preventive improvements to enhance process performance, cycle times, and quality outcomes.
• Benchmark industry best practices and integrates appropriate improvements into the process framework.
• Lead global initiatives to improve CAPA effectiveness, investigation quality, and closure performance.

Training, Change Management & Stakeholder Engagement

• Develop and maintain process training materials, guidance documents, and user support tools.
• Provide expert consultation and coaching to site and functional stakeholders regarding NC and CAPA requirements.
• Support organizational change management related to process updates and system enhancements.
• Facilitate global process owner forums, governance meetings, and stakeholder reviews.
• Build strong cross-functional partnerships to ensure effective process execution and continuous compliance.

Metrics & Reporting

• Develop dashboards, scorecards, and management reporting tools to monitor process performance.
• Analyze leading and lagging indicators to identify risks and improvement opportunities.
• Own enterprise reporting of NC and CAPA process performance and present performance trends, compliance risks, systemic issues, and improvement plans to executive leadership and governance bodies.
• Support Management Review processes through preparation and presentation of process health assessments

Qualifications

Knowledge, Skills, and Abilities:

• Demonstrated understanding of medical device Quality Management Systems, regulatory requirements, and applicable standards. (FDA 21 CFR Part 820, ISO 13485, EU MDR 2017/745, ISO 9001).
• Strong expertise in Nonconformance, Corrective and Preventive Action (CAPA), Root Cause Analysis, Risk Management, and Continuous Improvement methodologies.
• Strong understanding of business process management, process governance, and process performance management principles.
• Experience working with electronic Quality Management Systems (eQMS) such as Veeva Vault, Agile, or equivalent systems.
• Experience developing KPIs, dashboards, scorecards, and data-driven performance monitoring systems.
• Strong analytical and problem-solving skills, with ability to interpret complex data and identify meaningful trends.
• Ability to assess regulatory changes and industry best practices and translate them into process improvements.
• Ability to influence stakeholders across multiple functions and global locations without direct reporting authority.
• Excellent communication, facilitation, presentation, and stakeholder management skills.
• Strong project and process management capabilities.
• Advanced proficiency with Microsoft Office applications and quality reporting tools.
• Fluent in English, both written and verbal. Additional languages are considered an asset.

Experience:

Required:

• Minimum 7 years of progressive Quality Assurance, Quality Systems, Compliance, or Quality Engineering experience within the medical device, pharmaceutical, biotechnology, or other regulated industry.
• Demonstrated experience managing or leading Quality System processes such as CAPA, Nonconformance, Complaints, Audits, Change Control, or Risk Management.
• Experience leading cross-functional improvement initiatives and driving process standardization efforts.
• Experience supporting regulatory inspections, certification audits, or internal audit programs.
• Proven ability to manage complex issues involving multiple stakeholders and business functions.

Preferred:

• Prior experience serving as a Global Process Owner or Lead Process Subject Matter Expert.
• Experience implementing or enhancing eQMS workflows and solutions.
• Operational Excellence, or Continuous Improvement experience.
• Experience working in a global, multi-site medical device organization.

Education:

• Bachelor''s degree required in Engineering, Quality, Life Sciences, Biological Sciences, Business, or related technical discipline.
• ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Certified Manager of Quality/Organizational Excellence (CMQ/OE), or equivalent certification preferred.
• Lean Six Sigma Green Belt, PDCA, Kepner and Tregoe or equivalent continuous improvement certification preferred.

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.

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Travel:

This position requires approximately 10-15% travel, including domestic and international travel, to support global process harmonization activities, audits, training, workshops, business meetings, and continuous improvement initiatives.

Travel:

This position requires approximately 10-15% travel, including domestic and international travel, to support global process harmonization activities, audits, training, workshops, business meetings, and continuous improvement initiatives.