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Entegee
Quality Engineer
Career Insights for Product Quality Engineer
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Scorecard
Based on Minnesota data
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What they do
A Product Quality Engineer evaluates and tests products and manufacturing systems, to ensure that products are produced that meet quality and performance standards as well as safety and regulatory requirements. Develops product quality standards and monitors production and product testing.
$87,947 / year median in Minnesota
+1% projected growth
Job Description
Quality Engineer x8 - ALL LEVELS Multiple Quality Engineers to support its Post-Market Surveillance and Complaint Trending team. These positions range from Quality Engineer II through Principal Quality Engineer and will play a key role in monitoring product performance, identifying emerging quality and patient safety signals, and delivering data-driven insights that support regulatory compliance and risk management activities. Associate Quality Engineer Quality Engineer II Sr. Quality Engineer Principal Quality Engineer Required Qualifications Bachelor's degree in Statistics, Mathematics, Computer Science, Engineering, Data Science, Analytics, or a related technical field. Experience in Post-Market Surveillance, Quality Engineering, Complaint Handling, or related quality functions. Medical device industry experience required. Strong data analytics and statistical analysis background. Experience with Power BI dashboard development and data visualization. Knowledge of Risk Management principles. Understanding of Statistical Process Control (SPC) methodologies. Experience interpreting complex datasets and identifying trends. Strong communication skills with the ability to present findings to technical and non-technical stakeholders. Preferred Qualifications Experience supporting complaint trending, signal detection, or product safety monitoring. Proficiency with Python and/or R. Experience with SQL and relational databases. Process automation and analytical tool development experience. Knowledge of machine learning and predictive analytics. Experience in regulated industries such as medical devices, pharmaceuticals, or biotechnology. Key Responsibilities Perform complaint monitoring, statistical trending, and signal evaluation activities. Identify emerging product quality and patient safety concerns. Conduct signal assessments and present recommendations to management and cross-functional teams. Develop and maintain complaint monitoring tools aligned with risk management requirements. Execute ad hoc analyses supporting Quality, Regulatory, Clinical, Engineering, and business stakeholders. Create and validate Power BI dashboards, reports, and analytical tools. Apply SPC and advanced statistical methods to evaluate product performance. Support continuous improvement through automation, visualization, and process optimization. Investigate data anomalies and improve monitoring effectiveness. Ensure compliance with quality system and regulatory requirements. Contribute to advanced analytics initiatives including predictive modeling and machine learning applications. #