product development teams to ensure the manufacturability of new products. Monitor and analyze process performance metrics to identify areas for improvement. Implement Lean and SixSigma methodologies to drive continuous improvement initiatives. Troubleshoot process issues and work collaboratively to develop effective solutions. Prepare technical documentation, including process flows … of quality management systems and regulatory requirements (e.g., FDA, ISO 13485). Proficiency in statistical analysis and process improvement methodologies, such as Lean and Six Sigma. Ability to interpret engineering drawings and technical specifications. Excellent problem-solving skills and analytical thinking. Effective communication skills with the ability to work More ❯
In-depth knowledge and experience of product/process Risk Management (FDA and ISO standards). Technical training and experience using Statistics, Lean and SixSigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc. Strong knowledge of statistical software packages is preferred with the ability More ❯
In-depth knowledge and experience of product/process Risk Management (FDA and ISO standards). Technical training and experience using Statistics, Lean and SixSigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc. Strong knowledge of statistical software packages is preferred with the ability More ❯