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