Medical Device Quality Assurance Deputy
Title: Medical Device Quality Assurance Deputy
Contract: Fixed term 1 year – 80%
Reporting to: IMDQA coordinator and ITC coordinator
Applications deadline: December 31, 2015
I. 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.
II. 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, starting with the international purchase and with implementation priorities for Rapid Diagnostic tests, injection material and sutures. Other medical devices will be progressively included in this systematic quality assessment.
The current validation scheme has been endorsed by the medical directors.
The staff in charge of medical devices quality assurance in the MSF supply centers is part of the QA evaluation process, and the final decision is under the responsibility of the medical directors.
This activity is led by the International Medical Device Quality Assurance coordinator (IMDQA coordinator).
III. Objective of the position
In order to ensure the quality of medical devices used in MSF projects, the main objective is to support the IMDQA coordinator in the management of quality complaints for MD and IVDs and to be the focal point for any technical requests, quality and regulatory verification coming from the field, from the ITC coordinator and from the ESC QA referents, according to the SOP. The MD QA deputy is also in charge of a specific project on the implementation of safety devices on the field, under the responsibility of the IMDQA coordinator.
The second objective is to improve the quality of the medical catalogues with updated information on MD and IVD’s.
IV. Specific tasks
For batch recall quality complaint management
- Participate with the IMDQA coordinator in the risk assessment of quality issues
- Follow up with ESCs and support them for the management of quality complaints arising from the field or from manufacturers
- Update the quality complaints dashboard and archive key documentation.
For local purchase and donation
- Participate with the IMDQA coordinator to the remote QA verification for MD and IVDMD in collaboration with country or intersectional pharmacists (labelling assessment, interaction with Notified Bodies)
- Participate to local purchase assessment mission
For Technical advice and validation of Medical Device for selected medical device families
- Perform literature review on product clinical relevance and performance
- Coordinate the product technical validation by MSF working groups
- Coordinate field tests
- Support ESC with identification of new products sources compliant with the international quality standards
- Provide technical advice to OCs on product use, or alternatives adapted to MSF activities and environment
ITC technical sheets maintenance
- Propose improvements on the ITC catalog such as the review of the writing rules of the specifications of MD and IVD, focused on regulatory and normative aspects, in collaboration with the ITC coordinator
- Follow-up of different product families: liaise with IWG for revision of the concerned articles list: collect all new, changes and deletions for the integration to the catalogue and guides
- Coordinate the harmonization of the specifications with the support of ESC QA referents according to the rules previously set
- Support the ITC coordinator for any ad hoc requests on the technical sheets
V. Position within the organisation
The QA Medical Device deputy is under the direct responsibility of the IMDQA coordinator (Elsa Tran) and of the ITC coordinator (Vinciane Cruyt)
- Pharmacist with degree/diploma in Pharmacy or MD, with experience in quality assurance for medical devices
- Minimum 5 years of experience, with experience in MSF or similar organizations
- Good knowledge of MSF quality and procurement policies
- With experience in quality evaluation or regulatory environment
- Knowledge of developing countries and emerging market mandatory
- Experience in hospital pharmacy is an asset
- Fluent in English (French and/or Spanish would be an asset)
- Writing capacities
- Mature with strong interpersonal, communication and organisational skills
- Ability to work and report independently
- Willingness to travel
Contract: Fixed term 1 year – 80%
Starting date: ASAP
Please submit your application before 31st December, 2015 only by email to: IOfirstname.lastname@example.org with indicating “QA medical devices“ deputy in the title.
Please submit your CV and cover letter in ONE file and name the file with your LAST NAME.
Only short-listed candidates will be contacted