Quality Lead, Global QS NC & CAPA Process Owner

CooperVision, a business unit of CooperCompanies (Nasdaq: COO), is a leading global manufacturer of contact lenses dedicated to helping people experience life’s beautiful moments. The company is committed to improving vision through a diverse lens portfolio that addresses astigmatism, presbyopia, and childhood myopia, offering the most complete collection of spherical, toric, and multifocal products.

Job Summary

The Quality Lead, Global QS NC & CAPA Process Owner provides strategic oversight, governance, and continuous improvement of the enterprise Nonconformance (NC) and Corrective and Preventive Action (CAPA) processes. The role ensures global process standardization, regulatory compliance, system effectiveness, and operational excellence through performance monitoring, root‑cause analysis, stakeholder engagement, and digital process optimization.

Essential Functions & Accountabilities

• Serve as the Global Process Owner for NC and CAPA processes across the enterprise Quality Management System, accountable for effectiveness, compliance, and continuous improvement.
• Establish, maintain, and improve global procedures, standards, workflows, templates, and governance requirements.
• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, EU MDR, MDSAP, and other applicable regulations; assess external documents and implement actions to maintain compliance.
• Lead periodic process reviews to assess effectiveness, efficiency, and alignment with business needs; maintain RACI models and process maps.
• Establish governance mechanisms, escalation pathways, decision frameworks, and compliance monitoring activities; remediate gaps and non‑compliance trends.
• Support internal and external audits, regulatory inspections, and management review activities; act as the enterprise NC/CAPA SME during inspections and audits.
• Partner with Quality Systems and IT teams to define and maintain NC and CAPA requirements within the eQMS platform, including workflow design, user acceptance testing, and system enhancements.
• Identify opportunities for automation, digitalization, and simplification while maintaining regulatory compliance; support system deployments, upgrades, and validation.
• Develop and monitor global performance indicators and quality system health metrics; analyze data to identify systemic issues and improvement opportunities.
• Promote enterprise root‑cause analysis methodologies and provide coaching to ensure consistent problem‑solving practices.
• Lead global initiatives to improve CAPA effectiveness, investigation quality, and closure performance; benchmark industry best practices.
• Develop training materials, guidance documents, and user support tools; provide expert consultation and coaching to site and functional stakeholders.
• Facilitate global process owner forums, governance meetings, and stakeholder reviews; build cross‑functional partnerships for effective process execution.
• Create dashboards, scorecards, and management reporting tools; present performance trends, compliance risks, and improvement plans to executive leadership.
• Support Management Review processes through preparation and presentation of process health assessments.

Qualifications

• Minimum 7 years of progressive Quality Assurance, Quality Systems, Compliance, or Quality Engineering experience in a regulated industry (medical device, pharmaceutical, biotechnology, etc.).
• Demonstrated understanding of medical device Quality Management Systems and regulatory requirements (FDA 21 CFR Part 820, ISO 13485, EU MDR 2017/745, ISO 9001).
• Strong expertise in Nonconformance, CAPA, Root Cause Analysis, Risk Management, and Continuous Improvement methodologies.
• Experience with electronic Quality Management Systems (eQMS) such as Veeva Vault, Agile, or equivalent.
• Proven ability to develop KPIs, dashboards, scorecards, and data‑driven performance monitoring systems.
• Advanced analytical and problem‑solving skills with the ability to interpret complex data and identify trends.
• Ability to assess regulatory changes and translate them into process improvements.
• Excellent communication, facilitation, presentation, and stakeholder‑management skills; ability to influence without direct authority.
• Strong project and process management capabilities; advanced proficiency with Microsoft Office and quality reporting tools.
• Fluent in English (written and verbal); additional languages are an asset.
• Preferred: Experience as a Global Process Owner or Lead Process SME; experience implementing or enhancing eQMS workflows; Lean Six Sigma Green Belt or equivalent continuous‑improvement certification; experience in a global, multi‑site medical device organization.
• Education: Bachelor’s degree in Engineering, Quality, Life Sciences, Biological Sciences, Business, or related technical discipline.
• Preferred certifications: ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Certified Manager of Quality/Organizational Excellence (CMQ/OE), Lean Six Sigma Green Belt, PDCA, Kepner‑Tregoe, or equivalent.

Travel

Approximately 10–15% travel, including domestic and international trips, to support global process harmonization, audits, training, workshops, business meetings, and continuous‑improvement initiatives.

Pay

Starting base pay for this role is between $106,506.00 and $142,008.00 per year and may include cost‑of‑living adjustments. Additional compensation and benefits may also be available.