QUALITY ASSURANCE LEAD

CooperVision®, Inc., a unit of The Cooper Companies, Inc. (NYSE: COO), is one of the world's leading manufacturers of soft contact lenses. The Company produces a full array of monthly, two-week and daily disposable contact lenses, all featuring advanced materials and optics. CooperVision has a strong heritage of solving the toughest vision challenges; such as astigmatism, presbyopia and ocular dryness; and offers the most complete collection of spherical, toric and multifocal products available. QUALITY ASSURANCE LEAD MISSION: The Quality Assurance Lead for the CooperVision Madrid Distribution Centre is responsible for ensuring the consistent delivery of quality standards across all operations. This role oversees the development, implementation, and continuous improvement of quality systems, processes, and programmes, driving the effective governance, maintenance, and ongoing enhancement of the site’s Quality Management System (QMS). KEY RESPONSIBILITIES: · QMS Management and Maintenance: Maintain and continuously improve the ISO 13485-aligned QMS.. Ensure all quality procedures, policies, forms, and work instructions are controlled and up to date. · Regulatory Compliance with applicable regulations EU MDR 2017/745 ISO 13485 requirements relevant to distributors - Develop and maintain an annual internal audit schedule. - Non-Conformance and CAPA Management. Manage product, process, and QMS non-conformities. - Qualify and approve suppliers, logistics providers, and service providers. · Oversee customer complaint management processes · Product Traceability and Distribution Controls · Storage and Environmental Control. Ensure storage conditions meet requirements. - Ensure employees are trained on quality procedures. · Risk Management. Identify quality and compliance risks within the distribution process. · Manage quality-related change controls - Maintain recall and field safety corrective action procedures. · KPI and Quality Reporting · Certification Readiness (ISO 13485 Certification) REQUIREMENTS Around 5 years’ experience in Quality Assurance in Medical Device manufacturing or Pharma industry. Proven experience working with local and international regulations including Risk Management principles. Proven experience of working in an operations environment and with external suppliers and service providers. Bachelor’s degree required; engineering or technical field is preferred but will consider QA, Regulatory Affairs (RA) or equivalent relevant experience in a related environment. Certified Quality Engineer or Manager, Six Sigma Green Belt / Black Belt certification, Lean training a plus.