International coordinator for the quality of Medical Devices


Job Type

Full Time

Salary

Details: High 90’s to low 100’s USD/year gross and/or MD/PhD Profile: mid 110s to low 120s USD/year gross

Published:

04/13/2018

Application Deadline:

04/30/2018

Address

40 Rector Street
16th Floor
New York
New York
10006
United States

Description

Company

 

Doctors Without Borders/Médecins Sans Frontières (MSF) is an international humanitarian organization that provides medical care to people affected by conflict, epidemics, disasters, or exclusion from health care in over 70 countries.


We welcome candidates who bring a wide variety of backgrounds and experiences to join us in working toward MSF’s common mission.


 

Department

 

MSF currently operates activities in 35 countries with a wide spectrum of programs. The Medical Project Unit in MSF New York is part of the Medical Department of Operational Center – Paris (OCP) and provides technical support for: Tropical Medicine, Infectious Diseases (including antimicrobial resistance (AMR), medical quality, and medical article writing and publication. 

 

 

Project

 

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, including IVD, but not the Biomedical equipment. Both IVD and biomedical equipment deserve a dedicated specialist at international level. The current QA validation scheme has been endorsed by the medical directors. It involves the staff in charge of medical devices quality assurance in the MSF supply centers, and the final decision is under the responsibility of the medical directors.

 

In order to ensure the quality of medical devices, including IVD, used in MSF projects, the main objective is to ensure the consistency and the proper implementation of the intersection validation procedure for international purchase approved by the medical directors in 2013. This is part of a larger objective to improve quality supply of medical devices in MSF project including better selection, coordinated procurement, use under optimal conditions, etc. The secondary objectives are to improve the quality assurance for medical devices when local purchase is the only option, to initiate or continue the collaboration with external partners aiming to influence them for a better understanding and, other than for IVD and Biomedical equipment for which the international specialist is in charge, and to lead transversal projects like the revision of the transport policy.

 

Tasks

 

International procurement

-         Coordinate the implementation of the validation scheme SOP on the priority articles defined each year with the ESC QA referents

-         Ensure that the MD and IVDs selected and assessed according to the quality validation scheme match the needs expressed by the OC technical referents with the support of the deputy IMDC

-         Ensure that the quality assurance procedures and technical specifications are properly implemented and used at section level for all types of medical devices

-         Coordinate the manufacturers audits, technical visits, and monitoring visits for all products

-         Coordinate the input from external consultants

-         Ensure that all QA documentation and information is centralized on the tools available, i.e. oodrive, Unidata and Uniquality

-         Analyse QA policy for medical devices from other organisations (WHO,UNFPA, ICRC, etc.) and see how far MSF could rely on them – regularly update this analysis

-         Be the referent for general standards and regulation for the MSF movement

 

Local purchase and donation

-         Define SOPs for local purchase in line with the MSF medical procurement policy for approval by medical directors

-         Develop tools to ease the implementation of the local purchase SOPs (training material, rating system, check-lists…) with the support of the IVD internaiotnal specialist

-         Define criteria for local donation acceptance

-         Support the section pharmacists for countries with import constraints and specific needs

-         Perform technical visits at manufacturers’ sites for the most commonly available brands in MSF countries of operations

 

Management of internal network

-         Maintain the network with key people in the medical departments with the support of the deputy IMDC by participating to the relevant WG

-         Coordinate the management of quality complaints/batch recalls for MD, , with the ESC product focal points, technical referent at OC level or external experts as relevant according to the harmonized international SOP

-         Propose improvement of the SOP

-         Participate to / organise coordination meetings with ESC QA referents and MD referent in OCs

-         Coach / train new comers in the network

-         Work in close collaboration with the pharmacist and specialised food coordinators (respectively in charge of the quality assurance of medicines and specialised medical food for MSF projects) to reach a maximum level of harmonization in the documentation and practices

-         Issue annual reports such as quality complaints annual summary and analysis of local and international purchase

 

Development of a quality assurance approach for Biomedical products

-         Supervise the internal analysis on the needs and possible solutions for MSF proposed by the international Biomed specialist

-         Coordinate the proposal to be submitted to the medical directors for approval

-         Coordinate implementation accordingly

 

External collaborations / representations:

-         Promote the MSF quality assurance on medical devices (presentations, articles, etc)

-         Participate to network sharing the objectives to improve quality of medical devices on the international market

-         Link with other actors sharing the same concerns (UNICEF, WHO, etc)

-         Represent MSF in international forums

 

Specific objective for 2018-2019

Be the quality and regulatory team member in the scientific committee of the Minilab project

-         Implement the regulatory strategy validated by the scientific committee in 2017

Coordinate the QA assessment of the key IVDs component (dossier review and audit)

 

 

Requirements

 

Qualifications

-         Senior pharmacist with degree/diploma in Pharmacy with competence in quality assurance for medical devices

-         Other scientific diploma could be considered, if compensated by strong experience in quality assurance of medical devices (regulatory aspects included)

Work experience

-         Minimum 5 years of experience, with at least 3 years 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

-         Previous collaboration with pharmacists in other major organisations (WHO, UNICEF, ICRC, etc)

-         Experience in supply and procurement would be asset

Specific skills

-         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

 

Type

HQ

 

Contract Type

 

Open Ended Contract

 

 

Additional Information

 

Salary based on qualifications:

  • High 90’s to low 100’s USD/year gross
  • MD/PhD Profile: mid 110s to low 120s USD/year gross

 

Desired Hiring Date

 

ASAP

Professional Level

None specified

Minimum Education Required

No requirement

How To Apply

Please submit your application before April 30th, 2018 - only by email to:

IO-recruitment.gva@msf.org  

with indicating "QA medical devices"  in the title.

Only shortlisted candidates will be contacted.


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