Lead Design Quality Engineer

The Lead Design Quality Engineer will be a key leader in ensuring the safety, effectiveness, and compliance of medical devices throughout the design and development lifecycle.

Requirements

• Active representation of Quality function on product/process development teams
• Mentorship of other disciplines in Quality Engineering methodology
• Guidance to Engineering staff and other personnel on design control requirements
• Supplier management and qualification
• CAPAs/Non conformances investigation and management
• Design review participation and alternative design solution identification
• Hands-on participation in product development
• Design input and manufacturing documentation
• Contribution to design input requirements
• Participation in test plan development and validation
• Risk management throughout the development process
• Process improvement and continuous improvement in design control activities
• Compliance with regulatory laws/standards and Cooper's Code of Conduct
• Knowledge of statistics and data analysis