Senior Quality Engineer - Leiden

Vacancy information

Publication date:January 05 2021
Employment type: Permanent
Sector: Medical Devices
Function Group: Quality/RA

Function Group: Quality/RA / QA Engineer


For a start-up company active in the diagnostics industry, we are looking for a Senior Quality Engineer. This company develops innovative diagnostic systems that are able to detect diseases in the early stages. This increases the survival rates, improves healthcare, and reduces costs.


This Senior Quality Engineer role has a strong focus on documentation. You will be responsible for the correct and timely documentation to bring the QMS to the next level. You will ensure that templates and procedures are in place, as well as monitor the quality of the documentation.

As a Senior Quality Engineer, you are in the center of activities, and therefore work with cross-functional teams to optimise documentation. As a part of the quality department, you give general support where needed. During internal and external audits, you ensure all is compliant to MDR, ISO13485 and ISO27001.

As this is a small company, you will have plenty of freedom and responsibility to establish the QMS as you see fit. You will communicate with several stakeholders in different levels of the organisation.


The ideal candidate has the following:

  • Bachelor (HBO) level degree
  • Minimum three years of experience in quality management and document control
  • Worked with technical medical devices in the past
  • Knowledge of- and experience with relevant guidelines (ISO13485, MDR)
  • Fluent in English, fluency in Dutch is a plus
  • Strong writing skills in templates and guidelines
  • Motivated by a dynamic start-up environment
  • Accurate and detail oriented


The organisation can offer you the following:

  • A chance to grow into a Quality Manager role
  • Pension plan
  • Salary between €3.500,- and €4.500,- per month (this range is flexible, salary will depend on experience etc.)
  • Paid travel expenses
  • 25 vacation days


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




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