QA Specialist - Ghent

Vacancy information

Publication date:March 25 2021
Employment type: Permanent
Sector: Medical Devices
Function Group: Quality/RA

Function Group: Quality/RA / Quality Specialist

Organization

By exploiting ground-breaking photonics technology, this high-tech medical devices scale-up has developed an Active Implantable Medical Device (AIMD) that can address the patient’s need for accurate monitoring with an improved user experience. Their mission is to light up the life of millions of people and their families through innovative medical technologies. As the device has not been introduced to the market yet, and the first-in-human clinical research studies are being started, the QA Specialist will have a crucial role in the go-to-market preparations by setting-up and further developing the Quality Management System (QMS) and related activities.

Function

As a QA Specialist, you will work in a team of currently four QA professionals and report to the VP Quality Assurance. As this is a small team in a scale-up environment, this role requires a hands-on work ethic. You will perform several tasks with the main goal to set-up the QMS and write all necessary procedures, this includes tasks related to:

  • Ensuring audit readiness
  • Reviewing current quality procedures and processes and optimising where needed
  • Improving and developing of the QMS in close cooperation with other functions, such as manufacturing and supply chain quality management
  • Writing Standards Operating Procedures (SOPs)
  • Execute and monitor QMS procedures like document management/CAPA/Audit/training risk management, together with the quality team
  • Optimising and digitalising quality management tooling
  • Supporting other department is execution of their quality procedures including: Writing and building technical files; Writing manufacturing instructions

Requirements

We are looking for a motivated and driven candidate who has a hands-on mentality and at least two years of prior work experience in a similar role, in a manufacturing/ R&D environment. Additionally, the candidate should meet the following criteria:

  • Bachelor’s degree in a technical area
  • Experience with further developing/implementing a QMS based on ISO13485, or assisting in this
  • Experience working with a highly technical medical device, preferably Class III AIMD
  • Eligible to work in the EU/Belgium
  • Team player, eager to learn and dedicated to a high degree of accuracy
  • Process-oriented and a structured way of working
  • Strong communicator to all levels of the organisation
  • Open to work in a dynamic start-up environment

Offer

This role offers:

  • A high level of responsibility
  • A big role in the further building of the quality department of a promising medical devices scale-up
  • A competitive salary package with market-conform fringe benefits, dependent on experience

Application

If you are interested in this job, or in similar ones, please feel free to contact me directly.

Saskia Cepella
Senior Associate Quality & Clinical | Medical Devices

+31(0)6-13143973
+31(0)23-7548660
s.cepella@qtcrecruitment.com

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