Job Title QMS Specialist Job title QMS Specialist Your role Takes ownership of moderately complex processes in the assigned area areas Audits Document Control Training CAPA to ensure that QMS is efficient and meets the regulatory requirements Analyzes and interprets QMS performance data to identify trends process inefficiencies and potential areas for improvement and presents findings to management with recommendations for action Acts as a key liaison between the QMS team and other departments to ensure effective communication collaboration and alignment of QMS activities with business objectives and regulatory requirements Provides expert guidance and support to project teams in developing quality plans risk assessments and process validations to ensure compliance with QMS and regulatory expectations Leads cross-functional problem-solving sessions to address significant quality issues utilizing structured methodologies like root cause analysis and driving the implementation of cutting-edge solutions Prepare for and participate in external regulatory audits and inspections by ensuring readiness of documentation processes and records and provide responses to audit findings in collaboration with stakeholders Operates autonomously and contributes to development modification and execution of organizational policies impacting immediate operations of a business and or region and or function and potentially organization wide Conducts comprehensive risk assessments and management activities identifying potential risks to regulatory compliance quality and QMS integrity and developing and implementing robust mitigation strategies Champions continuous improvement initiatives within the QMS leading efforts to enhance processes tools and systems and driving a culture of quality excellence and operational efficiency throughout the organization Mentors a group of diverse talent to develop their skills and ensure achievement of individual and team goals and networks with key contacts