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  • Posted: Sep 26, 2022
    Deadline: Oct 7, 2022
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    Established in 1863, the ICRC operates worldwide, helping people affected by conflict and armed violence and promoting the laws that protect victims of war. An independent and neutral organization, its mandate stems essentially from the Geneva Conventions of 1949. We are based in Geneva, Switzerland, and employ some 14,500 people in more than 80 countries. T...
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    Medical Quality Assurance Office

    Overall Responsibility

    The Medical Quality Assurance Officer is responsible for ensuring that medical devices and IVDs (In-vitro diagnostic devices) are of suitable quality before purchase and remain so up to final delivery, including compliance to relevant regulations, international and ICRC standards.

    Tasks and responsibilities

    • Validate suppliers and items (global / regional / local purchase) for new items or replacement, including Quality Comparison Table (QCT) handling; ensures alignment with the procurement strategy for products under his/her portfolio regarding regulatory and quality requirements;
    • Manages relevant quality documentation on medical devices and IVDs based on international norms and standards, including but not limited to International Standards Organization (ISO) certificates, CE Certificates, EU type examination Certificates, Declaration of Conformity, Sterilisation certificates, Certificates of analysis (CoAs), free sale certificates (FSCs), material safety data sheets (MSDs), Instruction For Use leaflets (IFUs) and user manuals;
    • Coordinates the creation or update of ICRC item specifications with relevant stakeholders;
    • Assess and audit (documentary or physically) suppliers and manufacturers against any applicable requirements (for example good distribution practices (GDP) and/or good manufacturing practices (GMP), ISO 13485, ISO 9001, 14001 and 45001, Personal Protective Equipment regulations);
    • Identify risks and root causes associated with item quality and safety issues (proactively and/or reactively), and proposes/approves mitigation measures or solutions;
    • Manage or provide support in case of Recall / Field Safety Corrective Action;
    • Participate in Quality Management System lifecycle including but not limited to providing Quality Assurance support in a timely manner and efficiently addressing change requests and deviations;
    • Conducting regulatory intelligence.

    Minimum Requirements and competencies

    • University Degree in sciences or relevant Degree from a recognized university;
    • Minimum 10 years overall professional work experience in a similar field;
    • 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, GDSP, knowledge of ISO 9001, 14001 and 45001;
    • Previous experience in assessments/audits;
    • Experience working in an international organization will be an added advantage;
    • Advanced computer skills (Word, Excel, Power Point, SharePoint) with experience in ERPs;
    • Strong negotiation and communication skills;
    • Excellent command of written and spoken English;
    • Must be a Kenyan Citizen.

    Method of Application

    The interested candidates should fill up a form by clicking the link below on or before 07th October 2022 at 4:30 pm then submit their CV, motivation letter, including references details, supporting documents (Certificates, Diplomas, Degree etc) and current and expected remuneration to ICRC Nairobi Delegation, HR Department via the email address provided below:

    E-mail: nai_hrrec_services@icrc.org

    For Medical Quality Assurance Office

    The interested candidates should submit their applications on or before 07th October 2022 at 4:30 pm with the CV, motivation letter, including references details, supporting documents (Certificates, Diplomas etc) and current and expected remuneration to ICRC Logistics Support Centre, HR Department viaE-mail : lon_hr_rec_services@icrc.org

    The reference Medical Quality Assurance Officer must be stated in the application to be valid. If you do not clearly state the position for which you are applying & attach the required Degree & other supporting documents, your application will not be considere

    Send your application to lon_hr_rec_services@icrc.org

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