USP seeks Quality Assurance & Quality Control (QA/QC) Consultant with expertise in quality control of Medical Devices (eg rapid diagnostic test kits, condoms, surgical gloves ) for a potential 3-year project in DRC, where USP will provide assistance towards strengthening the maturity level of the National Pharmaceutical Regulatory Authority (ACOREP), strengthening capacities of the National Quality Control Laboratory, and developing strategy to strengthen local production of medicines and vaccines. The expert should have a strong background in establishing and implementing QMS for medical devices laboratories and in building capacity for QC testing of medical devices within quality control laboratories at country and regional levels. The expert should have proven ability to deliver training, provide technical assistance, conduct assessments, and mentor QC teams. The position requires solid knowledge of ISO 13485, ISO 17025 standards and WHO good practices, as well as demonstrated experience in strengthening medicines QA/QC systems through technical assistance and donor-funded programs.
**This opportunity is connected to a proposal. Any consultant engagement is contingent upon contract award.**
Roles and Responsibilities
Potential tasks that the consultant/vendor will be responsible for carrying out include:
· Developing training materials and facilitator’s guides for defined medical devices QC training.
· Developing pre- and post-test questions for defined medical devices laboratory QC training.
· Delivering defined medical devices QC training and evaluating the performance of the trainees.
· Providing technical assistance to NQCLs to implement QMS (e.g., ISO 17025, 13485) and WHO Good Practices.
· Providing mentorship and coaching to NQCL QA/QC teams.
· Conducting laboratory assessments using the Stepwise Assessment Tool Towards Accreditation (SATTA).
· Implementing the laboratory program unit’s laboratory systems strengthening approach.
· Providing technical support to NRAs on laboratory testing and national regulatory systems functions to reach WHO GBT Maturity Level 3.
· Serving as a technical resource among USP technical RSS staff on laboratory medical devices activities.
· Participating in the development of in-house training programs to ensure sustainability and transfer of knowledge.
· Providing inputs in the development of USP technical approach tools.
· Preparing technical and trip reports.
Qualifications
· Masters degree in microbiology, chemistry, biomedical sciences or other relevant science degree.
· Eight (8) years’ experience in quality control testing as per pharmacopeial standards, specifically for medical devices (eg rapid diagnostic test kits, condoms, surgical gloves)
· Ability to travel for up to 25% of the time (if applicable)
· Excellent written and oral communication skills, including experience in training and mentoring staff and others
· Strong written (especially technical writing) and oral communication skills in both English and French.
· Resides in the Africa Region (Please specify countries of experience)
· Solid knowledge and understanding of the norms and practices of pharmaceutical systems in Africa
· Knowledge of and experience with: Pharmaceutical systems in Africa, ISO 13485 ISO/IEC 17025:2017 and WHO Good Practices for Pharmaceutical Quality Control Laboratories, WHO Global Benchmarking Tool and other laboratory QMS assessment tools.
Preferred Qualifications
· Resides in the Africa Region (Please specify countries of experience)
· Demonstrated experience working in microbiology quality control testing within an NQCL or a private QC laboratory that conducts quality control testing of medical devices .
· Direct experience implementing donor-funded programs
Application Procedure Please send your CV, Cover Letter, 3 References, and hourly rate (in USD) to GPH_Procurement@USP.org, by the closing date of October 24, 2025. When submitting your applications, please write “QA/QC – Medical Devices” in the email Subject Line of your email.
The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality resources and standards for medicines, dietary supplements, and food ingredients. Through our resources, standards, advocacy and education, USP helps increase the availability of quality medicines, supplements and foods for billions of people worldwide. USP’s Global Health programs have reached more than 90 countries across Africa, Asia, and North and South America to strengthen global supply chains and pharmaceutical ecosystems that enable a resilient supply of quality medical products.
