Job Description
1. Develop measurement systems and capabilities, including destructive and non-destructive tests for manufacturing processes.
2. Support the development of control plans aligned with product classification, potential defect types, defect frequency, severity, patient risk, process capability, and process controls as part of design transfer.
3. Develop, interpret, and implement appropriate process monitoring and control methods based on the level of process/product risk.
4. Collect data and perform analytical and statistical analyses to support process improvements and daily operations.
5. Develop, interpret, and implement standard and non-standard sampling plans.
6. Assess the effectiveness of measurement tools, destructive and non-destructive tests, and measurement system analysis.
7. Maintain accountability and ownership for sampling plans, including evaluating the acceptability of risks considering product classification, defect types, severity, patient risk, process capability, and process controls. This includes applying and interpreting acceptance sampling standards for manufacturing data.
8. Require technical training and experience in Statistics, Lean, and Six Sigma methodologies, including Measurement System Analysis, SPC, and Design of Experiments (DOE).
9. Hands-on experience in related areas is essential.
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