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.