International IVD and Biomedical Equipment Quality Specialist
Contract: Full time, fixed-term
Duration: July 2017 – February 2018
Reporting to: International Medical Devices Coordinator
Starting Date: 1 July 2017
- MSF INTERNATIONAL
Médecins Sans Frontières (MSF) is an international, independent, medical humanitarian organisation that delivers emergency aid to people affected by armed conflict, epidemics, healthcare exclusion and natural disasters. MSF offers assistance to people based only on need and irrespective of race, religion, gender or political affiliation.
MSF International is the legal entity that binds MSF’s 21 sections, 24 associations and other offices together. Based in Geneva, MSF International provides coordination, information and support to the MSF Movement, as well as implements international projects and initiatives as requested. MSF International also provides administrative support to the MSF Access Campaign.
- CONTEXT AND RATIONALE
MSF, as humanitarian organization is committed to provide its projects with quality supplies. Since a few years, MSF has developed a systematic way to ensure the quality of medical devices in collaboration with the MSF European supply centers involved in the QA evaluation process, the final decision being under the responsibility of the International Medical Devices Coordinator by delegation of the medical directors.
The quality validation scheme for IVD relies on WHO prequalification process. However numerous IVDs needed by MSF are not in the scope of the WHO PQ and requires a full and in depth evaluation by MSF. Biomed articles, including the equipment and the consumables, are not yet subject to harmonized international quality policy.
- Objective of the position
In order to ensure the quality of IVD medical devices and biomed articles used in MSF projects, the main objective is to implement and propose improvements of the intersection validation procedure for international purchase for IVD approved by the medical directors in 2013, and to create an harmonized validation scheme for Biomed article under the supervision of the International Medical Device coordinator. A secundary objective is to strenghten the collaboration with external partners for a better mutual understanding of respective QA policy and smooth exchanges of information.
- Specific tasks
- Implement the international validation scheme for IVDs for new and existing products
- Be the technical referent for IVD under the scope of the WHO prequalification
- Organise the (re)validation of new and existing products resp. with ESC QA referents for products outside of the WHO prequalification scope according to the agreed product distribution
- Centralise the quality documentation for IVD and Biomedical equipment.
- Be the referent for general standards and regulation related to IVD and Biomed for the MSF movement
- Lead technical visits to manufacturer and attend to manufacturers audit as an observer
Organisation of an internal network
- Be the focal point for the LWG and the Biomed contact group for questions related to the quality and product validation
- Coordinate the management of quality complaints/batch recalls for IVD and biomed equipement with the ESC product focal points, lab advisors and biomed referent for IVD and Biomedical equipment according to the harmonized international SOP
External collaborations / representations:
- Promote the MSF quality assurance on IVD and Biomed (presentations, articles, etc)
- Participate to network sharing the objectives to improve quality of medical devices on the international market such as GDWG
- Link with other actors sharing the same concerns (UNICEF, WHO, etc)
- Represent MSF in international forums under ther responsibility of the IMDC
Local purchase and donation
- Support the IMDC in the development of procedures for local purchase of IVD and Biomed
- Support the OC for ad hoc remote validation of IVD and Biomed
Specific objective during the short term contract:
- Identify the needs for international coordination with regards to biomed equipment through feedback from internal experts (OC biomed referent, ESC Biomed referent and QA referent in charge of the quality of the consumables) and from medical department representative
V. Position within the organisation
The International specialist for the quality of IVD/Biomed is under the direct responsibility of the international medical device coordinator.
- Senior pharmacist with degree/diploma in Pharmacy
- Application from Biomedical engineer with competence in quality assurance for IVD and biomed equipment could be considered
- Minimum 2 years of experience, with at least 1 year in MSF or similar organizations
- Good knowledge of MSF quality and procurement policies
- Experience in quality evaluation or regulatory environment
- Knowledge of developing countries and emerging market mandatory
- Previous collaboration with other major organisations (WHO, UNICEF, ICRC, etc)
- Experience in supply and procurement would be asset
- Fluent in English (French and/or Spanish would be an asset)
- Writing capacities
- Mature with strong interpersonal, communication and organisational skills
- Ability to represent MSF in relevant meetings
- Ability to work and report independently
- Ability to motivate and lead colleagues
- Willingness to travel
Starting date: 1st July 2017
Contract: Fixed-term contract, full time position
Deadline for applications: 15 June 2017
Please submit all applications only by email to: IOfirstname.lastname@example.org stating
“International IVD and Biomedical Equipment Quality Officer” in the title.
Please submit your CV and cover letter in ONE FILE attached to the email and name the file with your LAST NAME.
- Only short-listed candidates will be contacted -