Description
Project Overview
The customer develops regulated medical-device systems used in clinical environments. These solutions include embedded diagnostic instruments, device firmware, connectivity components, web services, APIs, and cloud-hosted applications that process or store patient-related data.
We are looking for a Software Quality Assurance Senior Manager to lead the software quality organization and ensure that medical-device software is safe, reliable, fully verified, and compliant with applicable regulatory requirements.
Role Overview
The Software Quality Assurance Senior Manager will lead the strategy, planning, and execution of software verification and validation across embedded, connected, and cloud-based medical-device solutions.
The role combines people management, software quality leadership, regulatory compliance, test automation, and cross-functional coordination. The successful candidate will ensure that software products and documentation are audit-ready and that quality practices support both product safety and efficient engineering delivery.
The manager will lead and mentor Software Development Engineers in Test and Software Quality Assurance Engineers.
Requirements
Required Qualifications
- Bachelor’s degree in Computer Science, Software Engineering, Biomedical Engineering, Electrical Engineering, or a related technical discipline.
- At least 10 years of Software Quality Assurance experience.
- At least 7 years of leadership or management experience.
- Management experience within medical devices, healthcare technology, diagnostics, or another strongly regulated industry.
- Deep practical knowledge of IEC 62304.
- Strong experience working under ISO 13485 quality-management systems.
- Knowledge of FDA 21 CFR Part 11 and IVDR requirements.
- Demonstrated experience testing embedded software and firmware.
- Experience validating cloud-hosted applications and web-based APIs.
- Experience with hybrid edge-to-cloud system architectures.
- Proven ability to design, implement, and maintain automated test frameworks.
- Experience operating automated tests within regulated CI/CD environments.
- Strong knowledge of requirements-based testing and risk-based verification.
- Experience managing requirements-to-test and defect traceability.
- Understanding of cybersecurity principles and cybersecurity testing for connected products.
- Strong analytical, organizational, leadership, and problem-solving skills.
- Ability to translate technical and regulatory risks into clear business-relevant information.
- Excellent written and verbal English communication skills.
Technical Skills
- Test automation for embedded firmware and web-based APIs.
- Verification and validation of medical-device software.
- Requirements-based and risk-based testing.
- Software and system integration testing.
- Regression, performance, reliability, and cybersecurity testing.
- ALM and requirements-management systems.
- Jama Connect or comparable requirements-management tools.
- Jira or comparable issue and defect-tracking tools.
- CI/CD platforms such as Jenkins, GitLab CI/CD, or Azure DevOps.
- Test-result management and generation of controlled verification evidence.
- Configuration management and controlled software-release processes.
Preferred Qualifications
- Master’s degree in Computer Science, Biomedical Engineering, Software Engineering, or a related field.
- Experience with point-of-care or in-vitro diagnostic devices.
- Experience testing software that processes or stores patient data.
- Experience with hospital-connected medical devices.
- Knowledge of ISO 14971 risk-management practices.
- Experience supporting FDA submissions, IVDR technical documentation, and regulatory inspections.
- Experience introducing automation into an organization with predominantly manual testing.
- Experience developing SDETs and building an automation-focused software-quality team.
- Experience validating cloud infrastructure and connected-device ecosystems.
- Familiarity with software bill of materials, vulnerability management, threat modeling, and secure software-development practices.
- Experience applying AI tools within controlled verification or quality processes.
- Expected Deliverables
- Software quality and V&V strategy.
- Risk-based master test plans.
- Approved verification protocols and test cases.
- Automated testing framework and automation roadmap.
- Requirements-to-test traceability.
- Documented linkage between requirements, risks, defects, test cases, and test results.
- Software verification reports.
- Defect and anomaly assessments.
- Release-readiness and quality-status reports.
- Audit-ready software quality records.
- Software quality metrics and continuous-improvement plan.
- Success Criteria
The successful candidate will:
- maintain regulatory compliance throughout the software lifecycle;
- improve test coverage and traceability;
- reduce dependence on manual regression testing;
- provide reliable and reproducible verification evidence;
- improve early detection of product defects and safety risks;
- establish transparent release-readiness criteria;
- ensure that software documentation is complete and audit-ready;
- build an accountable, technically strong software-quality organization.
Job responsibilities
Key Responsibilities
- Define and lead the software quality strategy for regulated medical-device products.
- Lead the development and execution of software verification and validation strategies.
- Ensure compliance with IEC 62304, ISO 13485, FDA 21 CFR Part 11, IVDR, and applicable internal quality procedures.
Oversee software testing across:
- embedded diagnostic hardware;
- embedded firmware;
- device applications;
- cloud-hosted applications;
- web-based APIs;
- hybrid edge-to-cloud architectures;
- systems that process or store patient data.
- Ensure complete traceability between software requirements, risks, test cases, test results, defects, and release evidence.
- Establish and maintain test plans, test protocols, test cases, traceability matrices, and test reports.
- Ensure that software verification provides sufficient objective evidence to demonstrate compliance with approved requirements.
- Define risk-based testing strategies based on product safety, software architecture, intended use, and regulatory classification.
- Oversee functional, integration, system, regression, performance, reliability, cybersecurity, and release testing.
- Review software requirements for completeness, clarity, testability, and traceability.
- Review test results, unresolved anomalies, deviations, and residual product risks before release.
- Define software-quality gates and release-readiness criteria.
- Communicate quality risks, test status, unresolved issues, and regulatory readiness to engineering leadership and cross-functional stakeholders.
- Drive modernization of software-quality practices from predominantly manual testing toward an automation-first model.
- Define and oversee automated testing frameworks for embedded firmware, applications, and web APIs.
- Integrate automated testing into regulated CI/CD pipelines.
- Establish appropriate controls for test environments, test data, test tools, software builds, and release evidence.
- Evaluate and introduce AI-assisted tools for test-plan development, edge-case generation, test optimization, and predictive defect analysis.
- Ensure that AI-assisted activities remain controlled, reviewable, and compliant with quality-system requirements.
- Lead defect-management and software-anomaly review processes.
- Monitor quality metrics, defect trends, test coverage, escaped defects, and release readiness.
- Support root-cause analysis and corrective and preventive actions.
- Lead continuous improvement of software development and quality processes.
- Support internal audits, external audits, regulatory inspections, and submission-related activities.
- Manage, mentor, and develop SDETs and Software QA Engineers.
- Define team objectives, responsibilities, performance expectations, and professional-development plans.
- Support resource planning, hiring, prioritization, and allocation across multiple product initiatives.
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What we offer
Empowering Projects: With 500+ clients spanning diverse industries and domains, we provide an exciting opportunity to contribute to groundbreaking projects that leverage cutting-edge technologies. As a team, we engineer digital products that positively impact people’s lives.
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Comprehensive Benefits: In addition to equitable compensation, we provide a comprehensive benefits package that prioritizes the overall well-being of our consultants. We genuinely care about their health and strive to create a positive work environment.
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About GlobalLogic
GlobalLogic, a Hitachi Group Company, is a trusted digital engineering partner to the world’s largest and most forward-thinking companies. Since 2000, we’ve been at the forefront of the digital revolution – helping create some of the most innovative and widely used digital products and experiences. Today we continue to collaborate with clients in transforming businesses and redefining industries through intelligent products, platforms, and services.
