Responsibilities

• Develop measurement systems/capabilities, including destructive tests and non-destructive tests for manufacturing processes.
• Support new control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. as part of design transfer.
• Develop, interpret and implement process monitoring and control methods appropriate to the level of process/product risk.
• Collect data and perform analytical/statistical analyses 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, and measurement system analysis.
• Accountability and ownership for sampling plans of all types including the acceptability of risk given the product classification, defect types, defect frequency, severity, patient risk, process capability, process controls, etc., including assessing, applying and interpreting acceptance sampling standards for manufacturing data.
• Technical training and experience using Statistics, Lean and Six Sigma Methodologies are required including Measurement System Analysis, SPC, DOEs.
• Hands-on experience is preferred.

Qualifications / Skills

• Manufacturing processes
• Lean and Six Sigma, Measurement System Analysis, SPC, DOEs, Reliability
• Statistical software packages
• MS Office
• Regulatory compliance (FDA and European regulatory), GMP

Seniorities

• Entry level

Employment type

• Contract

Job function

• Quality Assurance
• Industries IT Services and IT Consulting