Quality Engineer

An opportunity is available for an experienced Quality Engineer to support quality systems, investigations, compliance, and continuous improvement within a regulated medical-device manufacturing environment.

• Medical-device industry experience is mandatory
• CAPA and Nonconformance Management experience
• Quality investigations and Root Cause Analysis
• Strong Quality Management Systems knowledge
• ISO 13485 experience
• FDA QMSR / 21 CFR Part 820 knowledge
• Continuous improvement and process-improvement experience
• Lean Manufacturing / Six Sigma knowledge
• Experience working within highly regulated manufacturing environments
• Bachelor's degree in Engineering, Quality, Manufacturing, Mechanical, Electrical, Industrial Engineering, or a related technical field.
• Manage and investigate nonconforming materials, products and processes
• Support the complete CAPA lifecycle, including investigation, documentation and effectiveness activities
• Conduct structured Root Cause Analysis (RCA) and problem-solving
• Maintain compliance with established Quality Management System requirements
• Support compliance with ISO 13485 and FDA 21 CFR Part 820 / QMSR requirements
• Identify and implement quality and manufacturing process improvements
• Apply Lean Manufacturing and Six Sigma methodologies to reduce defects and improve operational performance
• Support inspection-ready documentation and quality records
• Collaborate with manufacturing, engineering and other cross-functional teams to resolve quality issues