Quality Engineer I

About This Role

This Quality Engineer I role provides process and quality engineering support to manufacturing, ensuring high-quality products for customers. The position involves partnering with product development teams to develop new products and plays a critical part in maintaining product integrity, improving processes, and driving continuous improvement initiatives across operations.

Responsibilities

• Identify manufacturing process defects, including scrap, nonconforming material, and customer complaints, by dispositioning nonconforming material and assisting in root cause identification and corrective and preventive actions
• Support product containment activities, including product holds and release criteria documentation
• Review and interpret product and quality specifications, and work within quality systems to support compliance
• Perform risk analyses, including failure modes and effects analyses (FMEAs)
• Utilize process monitoring systems and tools to understand critical process steps and reduce process variation
• Analyze quality metrics and apply data-driven methods to support product and process improvement efforts for both sustaining and new product development
• Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues
• Provide production floor support and maintain line ownership responsibilities
• Execute final process monitor release activities prior to product distribution

Requirements

• Bachelor of science degree in engineering or related technical discipline
• Working knowledge of basic quality systems and good documentation practices

Nice to have:

• Strong written and verbal communication skills
• Ability to work independently with limited supervision
• Experience in the medical device industry in a manufacturing support role
• Experience providing quality line support
• Self-starter with the ability to identify and drive improvement opportunities
• Experience working in a production support function
• Experience leading cross-functional teams and driving projects to completion
• Demonstrated experience managing multiple projects across diverse engineering disciplines, including equipment qualification, process validation, and test method validation
• Experience collaborating with manufacturing engineering, CAPA, risk management, supplier quality, and process engineering teams
• Knowledge of analytical techniques, problem-solving methodologies, and statistical analysis
• Proficiency with Microsoft Office tools, including Word, Excel, PowerPoint, and Outlook
• Familiarity with product and component documentation, inspection and testing, and manufacturing execution systems (MES)