Quality Sr Engineer I

The Senior Quality Engineer at Zimmer Biomet is responsible for supporting the design, development, and lifecycle management of medical device software, including AI-integrated products. The role involves collaborating with design and development teams, maintaining product documentation, leading risk management, and ensuring compliance with quality and regulatory standards. Candidates must have a Bachelor’s degree in Engineering or Quality, at least 5 years of experience in quality engineering, and familiarity with ISO 13485. Strong communication skills and experience in regulated industries, particularly medical devices, are essential. The position is based on-site in Salt Lake City, Utah, with a salary range of $80,000 to $101,000 and up to 15% travel.

The Senior Quality Engineer at Zimmer Biomet plays a pivotal role in supporting the design, development, and lifecycle management of medical device software, including those incorporating artificial intelligence. This position collaborates closely with cross-functional teams to ensure compliance with quality, regulatory, and industry standards, while driving risk management, verification, validation, and continuous improvement initiatives. The role offers a dynamic environment with opportunities for professional growth, recognition, and a supportive culture. Compensation for this role ranges from $80,000 to $101,000, with additional benefits such as wellness incentives and competitive total rewards, as explicitly stated in the job description.

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.

What You Can Expect

The Senior Quality Engineer supports the design, development, and lifecycle support of medical device software, including software incorporating artificial intelligence, for new and existing products. This role works closely with design and cross-functional teams to support new product introductions, maintain software design documentation, and ensure compliance with applicable quality, regulatory, and industry standards. The position plays a key role in risk management, verification and validation activities, design reviews, cybersecurity considerations, and implementation of software changes throughout the product lifecycle.

How You'll Create Impact

• Partner with design and cross-functional development teams to support quality activities for new product introductions as well as maintenance on existing product lines.
• Lead or contribute to design, implementation, integration, and maintenance for product development projects.
• Maintain product design documentation and ensure it remains current throughout the product lifecycle.
• Support product changes, enhancements, defect corrections, and sustaining engineering activities for released products.
• Lead risk management activities, including hazard analysis, risk assessments, and implementation of risk controls.
• Support verification and validation planning, protocol development, execution, and documentation.
• Participate in design reviews and provide technical guidance to ensure robust, compliant, and maintainable solutions.
• Collaborate with quality, regulatory, systems, and test engineering teams to support compliance with internal procedures and external standards.
• Review and approve technical documentation, including, design documents, test protocols, traceability matrices, and change records.
• Provide technical leadership for complex troubleshooting, root cause investigations, and continuous improvement initiatives.
• Mentor engineers and serve as a technical leader across multiple projects and product platforms.
• Support audit, inspection, and regulatory submission readiness activities as needed.

What Makes You Stand Out

• Must be familiar with all aspects and elements of a quality system including but not limited to management responsibility, resource management, product realization and measurement, analysis and improvement processes.
• Knowledge on aspects of quality assurance techniques such as: inspection methods, statistical sampling plans, gauging and test methods concepts, validation, and statistical process control
• Demonstrated technical expertise
• Demonstrates ownership for the integrity of work
• Able to work independently or as part of a team and consider options for completing work
• Strong written and verbal communication skills

Your Background

• Bachelor’s Degree in Quality or Engineering field, or an equivalent combination of education and experience.
• Must be familiar with Microsoft Office Suite
• Must have minimum of 5 years of experience in Quality Engineering field
• Experience of working in a regulated industry, preferably medical devices.
• Experience working within a quality management system compliant with ISO 13485.
• Strong written and verbal communication skills.
• Proven ability to work effectively across cross-functional teams and influence technical decisions.

Physical Requirements

Travel Expectations

Up to 15%

Salary Expectations:

$80,000 - $101,000

On site in Salt Lake City, Utah

EOE/M/F/Vet/Disability

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a

Responsibilities:

• Partner with design and cross-functional development teams to support quality activities for new product introductions as well as maintenance on existing product lines.
• Lead or contribute to design, implementation, integration, and maintenance for product development projects.
• Maintain product design documentation and ensure it remains current throughout the product lifecycle.
• Support product changes, enhancements, defect corrections, and sustaining engineering activities for released products.
• Lead risk management activities, including hazard analysis, risk assessments, and implementation of risk controls.
• Support verification and validation planning, protocol development, execution, and documentation.
• Participate in design reviews and provide technical guidance to ensure robust, compliant, and maintainable solutions.
• Collaborate with quality, regulatory, systems, and test engineering teams to support compliance with internal procedures and external standards.
• Review and approve technical documentation, including design documents, test protocols, traceability matrices, and change records.

Skills:

• Must be familiar with all aspects and elements of a quality system, including management responsibility, resource management, product realization and measurement, analysis and improvement processes.
• Knowledge of quality assurance techniques such as inspection methods, statistical sampling plans, gauging and test methods concepts, validation, and statistical process control is essential.
• Demonstrated technical expertise and ownership for the integrity of work are required.
• Ability to work independently or as part of a team and consider options for completing work is necessary.
• Strong written and verbal communication skills are required.
• Familiarity with Microsoft Office Suite is necessary.
• A minimum of 5 years of experience in Quality Engineering is required.
• Experience working in a regulated industry, preferably medical devices, is preferred.
• Experience working within a quality management system compliant with ISO 13485 is required.

Education:

• A Bachelor’s Degree in Quality or Engineering field, or an equivalent combination of education and experience is required.