Process Quality Engineer

As a key member of our team at {company}, you will be responsible for developing and implementing measurement systems, conducting destructive and non-destructive tests, and supporting the development of control plans.

• Design and implement measurement systems, destructive tests, and non-destructive tests for manufacturing processes.
• Support the development of control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, and process controls.
• Develop and implement process monitoring and control methods in accordance with the level of process/product risk.
• Collect data and conduct analytical/statistical analysis to support process improvements and day-to-day operations.
• Develop and implement standard and non-standard sampling plans.
• Assess the effectiveness of measurement tools, destructive tests, non-destructive tests, and measurement system analysis.
• Ensure accountability and ownership for sampling plans, including assessing, applying, and interpreting acceptance sampling standards for manufacturing data.
• Provide technical training and experience using Statistics, Lean, and Six Sigma Methodologies, including Measurement System Analysis, SPC, DOEs, and Reliability.

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

The ideal candidate will have hands-on experience and technical training in Statistics, Lean, and Six Sigma Methodologies, as well as strong analytical and problem-solving skills. Additionally, they should possess excellent communication and interpersonal skills to effectively collaborate with cross-functional teams.

We offer a dynamic and challenging work environment, opportunities for professional growth and development, and a competitive compensation package.