About the ICRC
The International Committee of the Red Cross (ICRC) works worldwide to provide protection and humanitarian assistance to people affected by conflict and armed violence. We take action in response to emergencies and at the same time promote respect for international humanitarian law. We are an independent and neutral organization, and our mandate stems essentially from the Geneva Conventions of 1949. We work closely with National Red Cross and Red Crescent Societies and with their International Federation in order to ensure a concerted, rational and rapid humanitarian response to the needs of the victims of armed conflict or any other situation of internal violence. We direct and coordinate the international activities conducted in these situations.
Your Role
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.
Accountabilities & Functional 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, 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 activities including but not limited to providing Quality Assurance support in a timely manner and efficiently addressing complaints, change requests and deviations,
- “Statutory responsibility for the superintending and licensing of identified medical warehouse”,
- Conducting regulatory intelligence.
What we will look for in your profile
- University Degree in Pharmacy from a recognized university,
- Must be a registered pharmacist with the pharmacy and poisons board, Ministry of Medical Services, Republic of Kenya
- Minimum 10 years overall professional experience work experience in a similar field mandatorily involving medical devices,
- Experience in item selection for hospital practice; in-depth experience in the use of medical devices in a hospital environment
- 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) as amended, 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.
What we offer
- Diverse and humanitarian-minded workforce,
- An opportunity to contribute to institutional efforts to protect and assist conflict victims worldwide,
- Training opportunities,
- Flexible work schedule.
The interested candidates should submit their applications on or before 10th December 2024 at 4:30 pm with the CV, motivation letter, including references details, supporting documents (Certificates, Diplomas, Degree etc) and current and expected remuneration to ICRC Logistics Support Centre, HR Department via**:**
– E-mail : [email protected]
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 considered.
Only shortlisted candidates will be contacted.
Applicants must have the permanent right to work in Kenya.
The ICRC values diversity and is committed to creating an inclusive working environment. We welcome applications from all qualified candidates.
At the ICRC, we value impact, collaboration, respect, and compassion. We seek candidates who demonstrate behaviors based on these shared values. For more information on the ICRC values, please visit this page.
ICRC does not charge a fee at any stage of the recruitment process. All applications are free for all candidates, and no one should require any payment or compensation during the recruitment process. May the candidate be asked for any fee, they must report to ICRC HR Department through the recruitment contact.
More Information
- Job City Nairobi
