The Quality Manager is responsible for the Quality programs, systems, processes and procedures and that the performance and quality of services conform to established regulatory and accreditation requirements within the laboratory(ies) of the assigned area(s).
Key responsibilities · Demonstrates and promotes the company vision and policy.
· Ensure all radiology institutes within the assigned area(s) maintain current licensure.
· Ensures that the quality management system demonstrates regulatory compliance per ISO 9001, and other applicable regulations and standards from customers.
· Follows group policies and procedures.
· Promotes a culture of quality by educating others in quality management system fundamentals, programs and tools.
· Develop quality goals and objectives in collaboration with Group and local functional heads, assists in execution of these goals and report 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.
Assess risk, assists in root cause analysis and corrective action efforts.
Monitors trends and create reports for periodic quality meeting 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.
Follow-up of actions following audits.
· Participates in the preparation of certification dossiers, accompany auditors (e.g.
ISO quality inspectors) during audits of the radiology institutes and coordinates responses to audit findings.
· Act 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.
· Performs other duties as assigned.
Requirements Education and Experience · Bachelor's degree, preferred in medical imaging or radiology, with related professional experience within the healthcare environment.
· Fully versed in ISO 9001 and Risk Management.
· Demonstrated in-depth knowledge in quality process mapping and development.
· English fluent as a must (presenting, writing, reading). · Minimum Years Recommended and/or Preferred: 8-10 years.
Personal and professional attributes · Excellent interpersonal, organizational & communication skills with excellent attention to detail.
· Ability to influence and affect change.
· Rigorous, organized, autonomous.
· Ability to work independently and initiate contacts as necessary · Responsive problem solver and action oriented.
· Able to work effectively under pressure.