Senior Quality Engineer

What You Will Do

• Develop, implement, and maintain quality methods for process control, inspection, testing, and defect prevention within manufacturing operations
• Investigate internal and supplier-related nonconformances, lead root cause analysis, and manage timely corrective and preventive actions in alignment with quality system requirements
• Review, disposition, and document nonconforming product through formal material review processes, including containment and escalation when required
• Analyze quality data and key performance indicators, identify trends, and initiate actions to address emerging product or process risks
• Evaluate manufacturing and supplier changes, including process updates and component changes, to assess quality and risk impacts prior to implementation
• Support supplier quality improvement activities, including corrective action management, part certification initiatives, and ongoing performance monitoring
• Apply statistical methods and risk management practices to support process capability, inspection strategies, and sampling plans
• Support internal and external audits, manufacturing transfers, engineering changes, and field-related quality investigations as a subject matter resource
• Collaborate closely with manufacturing and engineering teams to identify, investigate, and resolve quality issues impacting production
• What You Will Need
• Required Qualifications
• Bachelor’s degree in Engineering, Science, or a related technical field
• Minimum 2 years of quality engineering or related quality experience within a regulated industry
• Preferred Qualifications
• Experience working with U.S. and international medical device regulatory requirements
• Experience managing nonconformance investigations and corrective action activities in a regulated quality system
• Experience supporting supplier quality activities or manufacturing process improvements
• Experience applying risk management and statistical process control methods in manufacturing environments
• United States of America Pay Ranges:
• USN: $77,700 - $129,500 USD Annual
• View the U.S. work location and transparency guide to find the pay range for your location.