Medical devices manufacturer, remediation project

Proclinical Staffing our consultant managing the role
Posting date: 01/03/2021

Medical devices manufacturer, remediation project

Case study

The overview

A multinational medical device manufacturer partnered with us for a remediation project when they failed an FDA audit.

The challenge

Following a warning letter, sent by the FDA, our partner voluntarily entered into a consent decree agreement and partnered with us to exclusively remediate the project. As a result of this agreement, they partnered with us to exclusively remediate the project. The main challenge was to align the internal hiring processes, which were too lengthy and complicated for the efficient onboarding of multiple contractors. This needed to be conducted under strict timelines and so a rapid turnaround time was going to be vital to the success of the project.

The solution

We conducted extensive market mapping of subject matter experts, utilising our unparalleled knowledge of the market and region, and mobilised local language speakers. This ensured that candidates were spoken to in their own language and created a smoother experience for both candidate and our partner.

We deployed a large multilingual delivery team to conduct an EU wide search, marketing, mapping and utilising our extensive network of available contractors in fields such as CAPA, validation, and post market surveillance. This meant we could cover the market incredibly quickly, providing shortlists almost immediately. We worked to educate our partner on recruitment best practice, realigning the interview process internally and creating an education piece around managing expectations accordingly. We set timelines for interview at the beginning of the process and for further efficiency, we used innovative screening software and psychometric testing, conducting a thorough and rigorous interview with each candidate.

The outcome

  • We efficiently worked to agreed deadlines, and delivered 33 hires (16 of which are still on site over a year later)
  • As a result of staffing qualified contractors into the project, their most recent FDA audit was a great success
  • We continue to partner with the organisation’s parent company, regularly assisting with the hires of permanent QA operatives