Medical Quality Assurance Officer

The Medical Quality Assurance Officer undertakes the following activities for medical supplies:

• Validates suppliers and items (global / regional / local purchase): for new items or products replacement (mostly medical devices, in-vitro diagnostic devices, medical equipment, veterinary products, personal protection equipment, biocides), including handling of the quality comparison table (QCT); ensures alignment with the procurement strategy for products in scope regarding regulatory and quality requirements.
• Enters and maintains the item code master data in JD Edwards software or equivalent logistic information system; ensures that all relevant data is kept up to date.
• Manages documentation on medical supplies by collecting, assessing and filing the relevant technical and quality documents, such as International Standards Organization (ISO) certificates, European Conformity (CE) Certificates, European Union-type examination certificates, declarations of conformity, sterilization certificates, certificates of analysis, free sale certificates, material safety data sheets, instruction-for-use leaflets and user manuals etc.
• Oversees the quality aspects of product testing: review of protocols / plans and reports to ensure their alignment with ICRC specifications and regulatory requirements; and approval
• Coordinates the creation or update of ICRC item specifications with relevant stakeholders
• Assesses and carries out audits (documentary or in-person) internally and for suppliers and manufacturers against any applicable requirements, e.g., good distribution practices (GDP) and/or good manufacturing practices (GMP), ISO 13485, ISO 9001, 14001 and 45001, personal protective equipment regulations.
• Leads or participates in quality assurance activities such as: identification of risks, investigation of root causes for quality incidents or complaints, proposal/approval of mitigation measures, corrective and preventive action (CAPA) plans, coordination of activities aimed at meeting quality standards, implementation of quality-control processes and participation to medical QMS lifecycle; perform quality controls when appropriate.
• Manages or provides quality assurance support to ensure that change requests and deviations are handled in an efficient and timely manner.
• Manages or provides support in event of recalls / field safety corrective action.