Radiology Quality Assurance Manager
hace 4 semanas
Quality Manager Radiology
The Quality Manager Radiology is responsible for ensuring the quality and performance of radiology services meet established regulatory and accreditation requirements.
Main Responsibilities:
- Demonstrates and promotes the company vision and policy.
- Ensures all radiology institutes maintain current licensure.
- Ensures the quality management system demonstrates regulatory compliance per ISO 9001 and other applicable regulations and standards.
- Follows group policies and procedures.
- Promotes a culture of quality by educating others in quality management system fundamentals, programs, and tools.
- Develops quality goals and objectives in collaboration with Group and local functional heads, assists in execution of these goals and reports results and any need for improvement to hierarchical superiors.
- Maintains and coordinates communications between institutes and sites, provides assistance where indicated on quality-related issues.
- Provides guidance for radiology institutes in implementing policies with respect to regulatory and certification requirements.
- Prepares quality meeting data/presentation.
- Conducts Quality Management Review meeting at least once per year in cooperation with radiology institutes management and Country Leadership Team.
- Ensures non-conformances, adverse events, and complaints are identified and documented, and that timeliness requirements are met. Assesses risk, assists in root cause analysis, and corrective action efforts. Monitors trends and creates reports for periodic quality meetings and management review.
- Manages post-market incident activities (field safety notice, vigilance reporting).
- Reports adverse reactions to Radiographic Contrast Media to the manufacturer and to the national regulatory authority, as applicable per local regulatory requirements.
- Ensures continuous improvement: indicators and dashboards, implementation, and monitoring of preventive and corrective actions.
- Plans and takes part in internal audits. Follows up on actions following audits.
- Participates in the preparation of certification dossiers, accompanies auditors (e.g., ISO quality inspectors) during audits of the radiology institutes, and coordinates responses to audit findings.
- Acts as the liaison between the radiology institutes and regulatory bodies or certification organizations.
- Ensures regulatory compliance of all radiology institutes by maintaining up-to-date knowledge of requirements and coordinating activities to fulfill requirements.
- Ensures appropriate implementation of the risk management procedure in all radiology institutes.
- Facilitates or participates, as applicable, in crisis management with relevant channels to ensure business continuity.
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