Quality Engineer
$100,000–$110,000 year
On-site · Fishers, Indiana, United States
Job Summary
Quality Engineer supports Quality Management System, Product Realization, and Manufacturing Process Controls; defines and generates quality control plans, production process controls and procedures; leads validation activities including statistical analysis; conducts process capability analyses and investigations of deviations and customer complaints; engages with customers to address quality issues and define acceptance criteria/attributes; performs quality process monitoring, audits, and CAPA activities with cross-functional teams; ensures alignment of customer specifications with site capabilities; maintains documentation repository; trains staff in metrology, GD&T, SPC, and new inspection techniques; collaborates with Operations and Engineering to ensure qualification/validation activities meet plan requirements; supports regulatory/compliance activities including US FDA and ISO 13485; participates in customer technical meetings and drives continuous improvement in quality performance.
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