وظائف تنقيب الاردنوظائف في الاردن
Medical Quality Assurance Officer
Medical Quality Assurance Officer
PURPOSE, SCOPE AND IMPACT
The Medical Quality Assurance Officer ensures that:
– the products in scope are of suitable quality before purchase and remain so up to final delivery
– items under ICRC control comply with relevant regulations as well as international and ICRC standards (including GXP and ISO 13485 requirements)
– appropriate and timely support is provided to the Quality Assurance and Regulatory Specialist and Medical Quality team as well as buyers worldwide for assessing products, manufacturers and suppliers.
S/he also supports the development, implementation, maintenance and improvement of the logistics medical quality-management system (QMS) for products within her/his portfolio and ensures that QMS performance objectives are met.
MAIN ACCOUNTABILITIES, DUTIES AND RESPONSIBILITIES
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.
- Monitors any changes to existing regulations or the introduction of new ones (regulatory intelligence) and informs relevant stakeholders.
- Acts as a back-up for the Quality Assurance and Regulatory Specialist when required.
- Ensures that risks are mitigated by performing the controls assigned to his/her role as described in the Logistic Risk and Control Matrix.
RELATIONSHIPS
- Internally, interacts with logistics staff at headquarters and in the field, Health and Forensic specialists and project teams.
- Externally, interacts with local medical and hospital management staff and other humanitarian players; with medical suppliers’ quality assurance team and with health ministry / relevant national authorities.
GENERAL DUTIES
- Be aware of the delegation’s objectives and activities
- Understand the three components of the Red Cross/Red Crescent Movement
- Apply the security rules at all times
- Respect and observe the staff regulations of the ICRC in Jordan.
- The employee may be asked to perform other duties not covered in this job description as well as to provide support to other departments when and if necessary.
- Understands and adheres to the seven Fundamental Principles of the International Red Cross and Red Crescent Movement
- Understands and adheres to the ICRC Code of Conduct
- Understands the roles of the components of the International Red Cross and Red Crescent Movement
- Respects and observes staff regulations and security rules at all times
- Represents the ICRC in a professional manner at all times
- Develops and maintains a pleasant and conducive working environment with colleagues and line managers
- Performs all duties with the highest level of confidentiality in the interest of the employees and the ICRC
- May be asked to perform tasks not covered in this job description and to provide support to other departments when necessary
PROFESSIONAL EXPERINCE AND EDUCATION REQUIRED
- Unversity degree in related field
- Typically, ten years of overall professional experience.
- At least 4 years of relevant experience in a position related to medical devices.
- Operating theatre nurse or hospital pharmacist, with good knowledge of medical devices and in-vitro diagnostics (IVD) and an interest in quality assurance.
- Experience in item selection for hospital practice; in-depth experience in the use of medical devices in a hospital environment and/or quality assurance management background in a medical device / pharmaceutical company.
- Strong knowledge of regulations, guidelines, and standards such as ISO 13485, MDR (regulation (EU) 2017/745), IVDR (regulation (EU) 2017/746, GMP, GDS, knowledge of ISO 9001, 14001 and 45001.
- Previous experience in assessments/audits.
- Excellent command of spoken and written of Arabic and English; good command of French or Spanish is an asset.
- Computer proficiency in Microsoft Office, including in Excel and good command of SharePoint.
- Experience working in an international context.
Interested to join? Apply now! The ICRC values diversity and is committed to creating an inclusive working environment. We welcome applications from all qualified candidates.
Please Note: "The position will be filled once we find the right candidate and the post is open for Jordanian nationals"
