To perform the required inspection and testing to according to eTR requests, scope include sample before and after EO for:
- Periodic revalidation
- Process parameter changes
- Worst case study
- Engineering study (trial run on setting/cycle time/temperature/formulation etc
- MDR process validation
- Holdback layer by layer re-inspection
- Holdback investigation/returned sample test eg, sample simulation
Others tasks as per assigned by superior.
Product scope: CPCS (raw cannula and clip stamping)