Quality Design Engineer 2

The Quality Design Engineer II is responsible for executing design changes, product enhancements, and quality projects, ensuring strategic and quality goals are achieved through technical design investigation, root cause analysis, and compliance with regulatory standards.

Requirements

• Design changes, product enhancements, and quality projects
• Root cause analysis, troubleshooting product, process, and component issues
• Develop solutions to design, process, and quality issues
• Work collaboratively with R&D, PQE, and RA to coordinate design elements of risk management files
• Support PMQA in performing complaint investigations and root cause analysis
• Design and prototype fixtures and establish methods to support design verification/validation activities and testing
• Develop test methods, protocols, and reports for design verification, validation, and process validation activities
• Execute protocols and laboratory notebook studies, maintaining accurate records of testing strategies and outcomes
• Support completion of Design History File documentation per FDA and other compliance requirements
• Coordinate work with outside vendors and internal personnel, including material procurement and testing
• Interact with internal and external customers to resolve quality issues related to complaints and/or customer experience
• Prepare complete project documents, including engineering reports and verification/validation documentation

Benefits

• Comprehensive training
• Continued development and training throughout career