Zandra – Quality Engineer (Manufacturing/Validation)
- Experience as a Validation Engineer with expertise in Root Cause Analysis, Process Validation and Packaging Validation, and Continuous Quality improvement
- Familiarity with statistical analysis methods i.e. co-relation, Principle component analysis, etc.
- Familiarity with various Root Cause Analysis tools i.e. DMAIC, 5 Whys, etc.
- Involved in Process Validation and Test Method Validation
- Experience using continuous improvement tools, such as FMEA, Root Cause Analysis, SPC analysis, PPAP, APQP and process mapping
- Subject matter expertise in packaging engineering or device/combination product assembly
- Knowledge of ISO, ASTM and ISTA Packaging Standards
- Ability to assist in test method/setup optimization, test fixture optimization, test data and yield
- Experience in SolidWorks, CATIA, Pro-E; 2D and 3D modeling experience
- Skilled in problem solving techniques involving Lean/Six Sigma statistical tools such as: Minitab, Cpk, Ppk, Crossed & Nested Gage R&R studies
- Experience with components of Lean Manufacturing
- Bachelor of Technology in Mechanical Engineering