Senior Quality Engineer, Medical Device Software & AI

Zimmer Biomet; Salt Lake City (UT); On-site; USD 80,000 - 101,000; Full time

Job summary

Zimmer Biomet is seeking a Senior Quality Engineer to support software for medical devices through design, development, and lifecycle management. You will ensure quality, regulatory compliance, and robust documentation across projects in Salt Lake City.

The role emphasizes risk management, V&V, design reviews, and cross-functional collaboration to deliver compliant solutions. Ideal candidates bring at least five years in quality engineering within regulated medical devices, strong communication,

Qualifications

• Bachelor's degree in Quality or Engineering, or equivalent.
• Minimum 5 years of experience in Quality Engineering.
• Experience in a regulated medical device environment.
• Experience with ISO 13485 quality management systems.
• Strong written and verbal communication with cross-functional influence.

Responsibilities

• Lead quality activities for new product introductions and sustaining engineering.
• Support risk management, verification/validation, and design reviews.
• Maintain current product design documentation and compliance.
• Collaborate with quality, regulatory, systems, and test teams.
• Provide technical leadership and supervise troubleshooting and improvements.

Skills

Quality systems

ISO 13485

Statistical methods

Root cause analysis

Technical leadership

Cross-functional collaboration

Communication skills

Education

Bachelor's in Quality/Engineering

Tools

Microsoft Office

Job description

Zimmer Biomet is seeking a Senior Quality Engineer to support software for medical devices through design, development, and lifecycle management. You will ensure quality, regulatory compliance, and robust documentation across projects in Salt Lake City.

The role emphasizes risk management, V&V, design reviews, and cross-functional collaboration to deliver compliant solutions. Ideal candidates bring at least five years in quality engineering within regulated medical devices, strong communication,