Software Quality Assurance Senior Manager

About the role

The Software Quality Assurance Senior Manager leads the software quality organization responsible for ensuring the safety, reliability, and regulatory compliance of software used in medical device systems. This role oversees verification and validation activities across embedded firmware and cloud-based applications, ensuring compliance with IEC 62304 and related regulatory standards. The position bridges engineering, regulatory, and business teams to deliver audit-ready software solutions used in clinical environments. The Senior Manager drives continuous improvement through automation, modern tooling, and AI-enabled quality practices.

Responsibilities

• Lead the development and execution of software verification and validation (V&V) strategies to ensure compliance with IEC 62304, ISO 13485, FDA 21 CFR Part 11, and IVDR requirements.
• Oversee software testing activities across embedded diagnostic hardware, firmware, and cloud-hosted applications that process and store patient data.
• Ensure end-to-end traceability between software requirements, risks, test cases, and defects using ALM and issue-tracking tools such as Jama Connect and Jira.
• Drive modernization of software quality practices by transitioning from manual-heavy testing approaches to automation-first strategies.
• Pilot and implement AI-assisted tools to support test plan development, edge-case generation, and predictive defect analysis.
• Manage, mentor, and develop Software Development Engineers in Test (SDETs) and QA Engineers, fostering a proactive and accountable quality culture.
• Communicate software quality risks, test results, and regulatory readiness to engineering leadership and cross-functional stakeholders.
• Perform other duties as assigned.

Requirements

• Minimum of 10 years of experience in Software Quality Assurance, including at least 7 years in a leadership or management role within the medical device, healthcare, or similarly regulated industry.
• Deep expertise in IEC 62304, ISO 13485, FDA 21 CFR Part 11, and IVDR regulatory requirements.
• Demonstrated experience testing embedded systems, cloud-based applications, and hybrid edge-to-cloud architectures.
• Experience operating within regulated CI/CD environments such as Jenkins, GitLab, or Azure DevOps.
• Strong analytical, problem-solving, and communication skills, with the ability to translate technical and regulatory risks into business-relevant terms.
• Solid understanding of cybersecurity principles and cybersecurity testing practices.
• Bachelor’s degree in Computer Science, Biomedical Engineering, or a related technical field required.
• Master’s degree preferred or an equivalent combination of education and professional experience.

Physical Requirements

• Ability to work at a computer for extended periods.
• Ability to lift and carry up to [25–50] pounds as required.
• Ability to communicate effectively via phone, video, and written communication.
• Ability to occasionally move about the office to access meetings or resources.