Organisation

Our client is an international provider of Supply Chain Solutions.

Function description

As Quality Coordinator you report directly to the Quality Assurance Manager Healthcare. As a team, you are fully responsible for providing optimal service, directly or indirectly, to our internal and external customers. The Quality Coordinator provides support in achieving and maintaining the required operational quality levels, and supports with audits and certifications (including EN ISO 9001:2015 and EN ISO 13485:2016 as well as being in compliance with GDP standards and the medical device regulations), TAPA-A, AEO, Regulated Agent & IATA for all branches.

Dealing with the ERP System, the safety of staff, compliance to procedures, ensuring the safety of protection of products and patients as well as dealing with Deviations / CAPAs, complaints, audit findings and implementing the actions  and facilities plays a central role. 

Tasks and responsibilities:

  • Audit accuracy of process documents such as Work Instructions; identify gaps;
  • Audit compliance of Work Instructions by Operations and Management;
  • Management/maintenance of quality systems, including ISO;
  • Establishing and monitoring quality KPIs;
  • Preparation and updating of annual planning analysis and monitoring to support the quality management system;
  • Preparing, following and supervising audits, together with the QA Manager and the Operations Manager;
  • Recording risks and compiling risk analysis (e.g. according to EN ISO 14971);
  • Providing support and input on reporting and analysis to the QA Manager and Healthcare and the Operations Manager;
  • Compiling relevant data for documentation, such as calculations, working drawings and operational instructions;
  • Support Ops with investigating quality failures / non-conformities by means of root cause analysis methodology;
  • Support training of Ops in Lean/Quality awareness to build quality into Operational processes and mind-set.

Function requirements

  • You have completed a relevant Higher Professional Education (HBO) course or equivalent;
  • 3 to 5 years’ demonstrable experience in the quality management field (including EN ISO 9001 and EN ISO 13485), in addition to experience with RA and CAPA investigation and effective implementation;
  • Knowledge of following up on audit findings, preparing audits and conducting internal audits;
  • Knowledge of MS Office. Experience with SAP and SharePoint is an advantage;
  • Knowledge of the English language is essential.

Location

Regio Noord Limburg

Do you see yourself in this function profile, then apply now.
If you would like more information about this vacancy, then please contact Suzanne Akveld.

Contact:

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Suzanne Akveld
T: 077-3201320

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