Quality Sr Engineer I

Zimmer, Inc.•Warsaw, IN

3d•$80,000 - $100,000

About The Position

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. The 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. It contributes to risk management, verification and validation, design reviews, cybersecurity considerations, and implementation of software changes throughout the product lifecycle. The position also provides technical leadership for complex troubleshooting, root cause investigations, and continuous improvement, mentors engineers, and supports audit, inspection, and regulatory submission readiness activities as needed. Travel is expected up to 20%.

Requirements

Bachelor’s degree in Quality or an Engineering field, or an equivalent combination of education and experience.
Minimum of 5 years of experience in the Quality Engineering field.
Familiarity 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.
Must be familiar with Microsoft Office Suite.
Experience working in a regulated industry.
Experience working within a quality management system compliant with ISO 13485.
Strong written and verbal communication skills.
Demonstrated technical expertise and ownership of work integrity.
Ability to work independently or as part of a team and consider options for completing work.
Proven ability to work effectively across cross-functional teams and influence technical decisions.

Nice To Haves

Experience in the medical device industry is preferred.

Responsibilities

Partner with design and cross-functional development teams to support quality activities for new product introductions and maintenance of existing product lines.
Lead or contribute to design, implementation, integration, and maintenance for product development projects.
Maintain product design documentation and keep it 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 promote 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.