For an innovative international organisation operating in medical devices and healthcare technology, we are looking for a QA Officer. The company develops medical imaging solutions, AI software and mobile healthcare solutions that support improved diagnostics and accessible healthcare worldwide. Quality, innovation and international collaboration are central to the organisation.

Job Description
As a Quality Assurance Officer for Medical Devices, you will be responsible for maintaining and continuously improving the Quality Management System (eQMS). You will provide support during internal and external audits and ensure that quality and regulatory documentation remains complete, up to date and compliant. In doing so, you will work closely with various internal teams.

Responsibilities

  • Managing and improving the Quality Management System, eQMS, document control and release processes
  • Coordinating, supporting and following up on internal and external audits
  • Managing CAPAs, change controls, audit findings, supplier qualifications and training matrices
  • Identifying and implementing improvements to the efficiency and user-friendliness of the eQMS
  • Acting as process owner for quality processes and procedures
  • Maintaining quality and regulatory documentation, including CE/MDR and ISO certificates

Job requirements

  • At least three years’ experience in Quality Management, preferably within the medical devices sector
  • Experience in maintaining and improving a QMS or eQMS
  • Knowledge of GMP, ISO 13485, MDR and relevant quality processes
  • Experience with audits, CAPAs, change controls and document control is an advantage
  • An affinity for software as a medical device, AI and IEC 62304
  • Experience with Atlassian, Jira, Confluence or SharePoint is a plus

Company Profile
Our client is a growing, internationally oriented organisation in the healthcare technology sector, based in the ’s-Hertogenbosch area of North Brabant. Through its products and software, the organisation supports healthcare professionals in delivering reliable diagnostics in a wide range of circumstances, including regions where access to healthcare is limited. You will be joining a multicultural and collaborative environment, where ownership and continuous improvement are encouraged.

What they offer

  • A salary of between €4,500 and €5,500 gross per month
  • A working week of 32 to 40 hours
  • A one-year contract with the prospect of a permanent position
  • Two days’ remote working per week for full-time employees, with a minimum of three days in the office
  • 25 days’ annual leave
  • Pension contributions paid in full by the employer

Get in touch now!
Are you interested in this vacancy for a QA Officer (Medical Devices), Quality Assurance Specialist or QMS Officer? Please contact Annebeth Simons on 030 20 03 408, send a WhatsApp message to 06 59922296 or email a.simons@morgangreen.nl.