Process Quality Engineer

Overview

Join our dynamic team as a Process Quality Engineer and be at the forefront of ensuring excellence in manufacturing and production processes. In this role, you will drive quality improvements, develop robust procedures, and uphold the highest standards of safety and compliance. Your expertise will help optimize operational efficiency while maintaining unwavering commitment to product quality and customer satisfaction. This position offers an exciting opportunity to influence quality standards across the organization and contribute to continuous improvement initiatives.

• Must have experience working with Medical Device Manufacturing


• 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.

Expected hours: 40\.0 per week

Work Location: In person

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