Senior Manufacturing Quality Engineer

What will you be doing?

• Lead nonconformance management and CAPA activities, including root cause investigations and implementation of corrective and preventive actions
• Partner with manufacturing and operations teams to enhance process robustness and reduce variation and defect rates
• Ensure compliance with applicable regulatory and quality standards including ISO 13485, FDA 21 CFR Part 820, and ISO 14971
• Drive continuous improvement initiatives using risk based methodologies such as PFMEA
• Support development of inspection strategies including measurement system analysis
• Perform data analysis using statistical tools to evaluate and improve process capability
• Support process validation activities including IQ, OQ, and PQ

What will you need to be successful?

• Education: Bachelor’s degree in Engineering such as Mechanical, Biomedical, Industrial, or a related discipline
• Experience: 3 to 5 years of experience in quality engineering within a manufacturing environment
• Experience working in a regulated industry
• Knowledge: Strong understanding of quality systems, risk management, and statistical analysis