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Job Description
The Quality Compliance Specialist is responsible for coordinating and executing the regional Quality Compliance program across EMEA. This role leads the planning and performance of internal audits, supports external regulatory and certification audits, prepares Management Review reports, and contributes to the effective operation and continuous improvement of the Quality Management System (QMS) throughout the region.
Key Responsibilities
• Develop and maintain the annual EMEA internal audit program based on risk, regulatory requirements, and business priorities.
• Plan, conduct, document,
and report internal audits across EMEA locations and functions.
• Monitor audit findings and support site management in the timely implementation and closure of corrective and preventive actions (CAPAs).
• Coordinate and support external audits, including notified body, certification body, customer, and regulatory inspections.
• Prepare and consolidate Management Review inputs and reports, ensuring accuracy, completeness, and timely delivery.
• Analyze quality metrics and trends to support Management Review discussions and decision-making.
• Support maintenance and continuous improvement of the Quality Management System in accordance with applicable regulations and standards.
• Provide guidance to functions and sites on quality compliance requirements, audit readiness, and best practices.
• Support Quality activities across the region, including CAPA management, quality risk management, document control, change manageme
📌 Quality Assurance Specialist (España)
🏢 BD
📍 España