As a Validation Engineer you will become responsible for further improving our validation approach in the field of 3D printing metal implants.
Note: initially, you will focus on the metal implant 3D printing and post-processing process. Further scope extensions are expected in the future.
Your initial scope will be mainly around 2 topics:
- QMS compliance of Validation dossiers
- Integration of 2 existing validation dossiers (aMace & TruMatch) inside the QMS system:
- Review approach & documentation of 2 existing validation files (MasterFile, test protocols, approach, …) of aMace & TruMatch
- Integrated used approach & documentation inside QMS SOPs
- Based on outcome of validation dossiers, set re-validation requirements after process changes such as 3D print maintenance actions
- This is a short-term task with high priority
- Prepare future validation dossiers by establishing best practices inside QMS
Note: the hereunder tasks are the core of the Validation Engineer’s tasks and should become the main task after the initial QMS compliance works
- Recommend & implement further improvements to the QMS system leading to improvements to the Validation Dossier approach and documentation hereoff
- This is a mid-term task with high priority
- Take part in execution of new Validation Dossier approach by writing validation/research test protocols “TP’s” (together with material/process experts) and ensure these are correctly translated into instructions for the operators/production team
- Analyse test data (via statistical analysis in MiniTab) to confirm expected relevant links – but also unexpected links – between different test data, and write test data analyse “DAT” reports
- Execute a detailed metal implant manufacturing Process Variability Assessment, continuously updated based on lessons learnt
- Translate Research process insights/pre-tests – which have been assessed to be relevant for the process Validation – into best practices documented inside the QMS
Through the above, you will become a Knowledge Expert in the field of 3D printing and play an important role in obtaining a better continuity and knowledge distribution
of the expertise being build up inside the PRD team.
You will work from the HQ of Materialise in Belgium and you will be part of a small team of experts working closely together with other teams.