Senior Quality Engineer

Medtronic seeks a Senior Quality Engineer for its West Valley, Utah manufacturing facility to lead process validation activities and ensure regulatory compliance in medical device production. The role involves partnering with manufacturing and engineering teams on quality standards, root cause investigations, and continuous improvement within a regulated environment.

Responsibilities

• Lead process validation lifecycle activities including planning, protocol development, execution, and reporting
• Partner with manufacturing and engineering to develop and maintain quality standards and process requirements
• Drive root cause investigations, corrective and preventive actions, and nonconforming material activities
• Analyze quality and process data using statistical methods to support continuous improvement initiatives
• Mentor quality and engineering colleagues on complex validation projects

Requirements

• Bachelor's degree in Engineering or Science with 4+ years quality/engineering experience, or Master's with 2+ years, or PhD
• Experience leading process validation in regulated manufacturing environments
• FDA-regulated medical device or pharmaceutical manufacturing background
• Statistical analysis tools proficiency, such as Minitab
• Knowledge of CFR requirements, engineering drawings, machining, and sterilization processes
• ASQ Certified Quality Engineer, Lean Six Sigma, or equivalent certification preferred
• Unrestricted U.S. work authorization at time of hire