Quality Software Validation Manager

Zimmer Biomet•Austin, TX

45d

About The Position

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 Software Quality Manager is responsible for ensuring the quality, safety, and compliance of software developed for medical device robotic systems, including embedded, cloud-based, and mobile applications. This role provides leadership and technical direction in software validation, verification, regression testing, and cybersecurity to ensure compliance with FDA, ISO 13485, IEC 62304, and ISO 14971 standards. The Software Quality Manager partners closely with R&D, Cybersecurity, Systems Engineering, and Regulatory Affairs to ensure all software products meet design control, risk management, and validation requirements throughout the product lifecycle.

Requirements

Deep understanding of software validation, verification, and risk management for medical devices or robotic systems.
Knowledge of relevant regulations and standards: 21 CFR Part 820, ISO 13485, IEC 62304, ISO 14971, and FDA guidance on software validation and cybersecurity.
Experience with penetration testing, cybersecurity validation, and data integrity requirements.
Strong technical understanding of software development environments including C#, C++, Python, and web technologies.
Proficiency in software quality tools: JIRA, TestRail, Polarion, Jenkins, and Git.
Strong leadership, analytical, and problem-solving skills with proven ability to manage competing priorities.
Excellent communication, documentation, and collaboration skills, with the ability to lead discussions across technical and non-technical teams.
Demonstrated ability to drive a culture of quality in agile or hybrid development environments.
Bachelor's degree in Software Engineering, Computer Science, Electrical Engineering, or related field.
Minimum 8 years of experience in software quality assurance, validation, or testing for regulated medical devices.
Minimum 2-3 years of leadership or management experience in software quality, validation, or compliance.

Nice To Haves

Experience in robotic systems, control software, or safety-critical applications is highly desirable.

Responsibilities

Lead the Software Quality Assurance (SQA) strategy and execution for robotic medical device systems, ensuring compliance with applicable FDA and ISO regulations.
Develop and maintain software validation and verification master plans (V&V), test strategies, and detailed protocols for both embedded control software and user-facing applications.
Oversee regression testing, penetration testing, and cybersecurity validation, ensuring robust design protection and secure data handling.
Collaborate with Software Engineering and Systems teams to ensure requirements traceability, defect tracking, and risk mitigation across the development lifecycle.
Ensure validation activities align with design control documentation (e.g., Design History File, Risk Management File, and Verification & Validation Reports).
Drive the integration of automated testing frameworks for continuous integration and delivery pipelines, supporting both development efficiency and compliance evidence generation.
Manage a cross-functional team of software quality engineers, validation specialists, and cybersecurity test partners (internal and external).
Represent Quality during design reviews, risk assessments, and change control boards.
Support audit readiness and serve as the software quality SME during internal, FDA, and Notified Body audits.
Lead continuous improvement in software quality systems, including procedures for software validation, configuration management, and defect tracking.
Partner with IT Security and Cyber teams to define and execute penetration and vulnerability assessments.
Ensure all software quality activities are executed per IEC 62304 (Software Lifecycle Processes) and align with the company's QMS.