Senior Quality Systems Manager

The Senior Quality Systems Manager is responsible for overseeing the quality management system (QMS) to ensure compliance with regulatory standards, improve process efficiency, and maintain product quality.

Requirements

• Manage and administer the Electronic Quality Management System (eQMS)
• Chair Change Control and CAPA review boards
• Develop, implement, and maintain robust quality metrics
• Conduct trend analysis of nonconformances, deviations, and complaints
• Ensure compliance with FDA regulations, ISO 13485, Medical Device Directive, and other applicable standards and regulations
• Manage the CAPA system to ensure appropriate investigation, implementation, closure, and effectiveness checks meet required timelines
• Manage the change control system, coordinating the initiation, execution, and completion of changes
• Manage audit planning, scheduling, and execute internal and external audits
• Establish, manage, and track quality system performance metrics

Benefits

• Competitive salary
• Benefits package
• Opportunity for professional growth and development