Job Description-
- Develop measurement systems/capabilities, destructive tests, non-destructive tests for manufacturing processes.
- Develop control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.
- Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk
- Collect data and execute/conduct various analytical/statistical analysis and interpretations as part of process improvements and day-to-day support.
- Develop, interpret and implement standard and non-standard sampling plans
- Assess the effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis.
- Accountability and ownership for sampling plans of all types including the acceptability of risk given the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. including assessing, applying and interpreting acceptance sampling standards for manufacturing data.
- Assess and interpret common versus special cause variation in manufacturing processing and determine the adequacy of current process limits
- Technical training and experience using Statistics, Lean and Six Sigma Methodologies are required including Measurement System Analysis, SPC, DOEs,
- A thorough understanding of GMP/ISO regulations and validation regulations is preferred. Reliability, etc.