Description
The client is a global leader in the medical technology sector, specializing in advanced diagnostic and surgical systems that combine precision mechanics, real-time control, and highfidelity imaging.
GlobalLogic is driving the engineering, quality, and regulatory alignment for next-generation MedTech solutions, medical cloud platforms, and connected clinical diagnostic technologies. The platform integrates cloud-native microservices (.NET / Java), enterprise databases, embedded software components, and real-time clinical workflows operating under strict international medical device standards and cybersecurity frameworks.
The Senior Software Quality Engineer (SQA) will drive, execute, and maintain the Software Quality Assurance strategy across the entire software development life cycle (SDLC). Operating within an Agile/hybrid delivery model, the engineer ensures that all engineering processes, risk management activities, automated quality gates, and software deliverables comply with Client’s Quality Management System (QMS)and regulatory requirements.
Requirements
- Bachelor’s degree or higher in Software Engineering, Biomedical Engineering, Electrical Engineering, Computer Science, or a related technical discipline.
- 5+ years of experience in Software Quality Assurance or Quality Engineering within the medical device industry, specifically working with Software as a Medical Device (SaMD) or complex embedded/cloud medical systems.
- Proven track record of executing SQA strategies, defining quality metrics, mentoring peer engineers, and driving QMS process adoption within cross-functional delivery teams.
- Practical understanding of core medical device standards and regulations: ISO 13485, IEC 62304, ISO 14971, and FDA Quality System Regulation (21 CFR Part 820).
- Hands-on expertise in authoring and executing complex Software V&V strategies, preparing Design History Files (DHF), maintaining Traceability Matrices (RTM), and evaluating test evidence across manual and automated testing streams.
- Experience in risk analysis methodologies (FMEA, FTA, Hazard Analysis), non-conformance triage, CAPA investigations, and defect root-cause resolution.
- Strong familiarity with software development concepts like: cloud infrastructure (Azure/AWS), programming languages (.NET, Java, C++), API architectures.
- Practical experience integrating QMS quality gates with modern CI/CD pipelines, static analysis scanning (SAST/SCA), and automated testing frameworks (AQA).
- Participating in internal QMS audits and serving as a technical SQA subject matter expert during external regulatory inspections (FDA, Notified Bodies).
Job responsibilities
- Implement and maintain project-specific Software Quality Assurance plans aligned with Hologic’s QMS; ensure IEC 62304-compliant Agile/hybrid SDLC workflows and track quality KPIs (e.g., test coverage, defect leakage, audit readiness).
- Review and author critical software lifecycle deliverables, including Software Development Plans, SRS, Architecture & Design Specifications, Risk Management Files, V&V Plans/Reports, and Usability Engineering files (IEC 62366).
- Support software risk management activities, ensuring software hazards are properly identified, risks are assessed, and control measures are accurately implemented and verified.
- Drive the software V&V process, ensuring testing strategies (both manual and automated) provide comprehensive coverage based on requirements and identified risks.
- Participate in internal quality audits of software processes and technical documentation; serve as an SQA technical representative during external client audits, FDA inspections, and Notified Body reviews.
- Enforce Definition of Done (DoD) blocking rules in CI/CD pipelines, execute software change control procedures, and triage software defects to prevent non-conformances from reaching release stages.
- Guide developers, architects, and QA engineers on QMS procedures, regulatory standards, and software quality best practices to foster engineering excellence and patient safety.
- Deliver release readiness assessments, compliance summaries, and defect metric trends to Delivery Managers, Solution Architects, Lead SQA Engineers, and Hologic quality leadership.
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.
Empowering Growth: We foster a culture of continuous learning and professional development. Our dedication is to provide timely and comprehensive assistance for every consultant through our dedicated Learning & Development team, ensuring their continuous growth and success.
DE&I Matters: At GlobalLogic, we deeply value and embrace diversity. We are dedicated to providing equal opportunities for all individuals, fostering an inclusive and empowering work environment.
Career Development: Our corporate culture places a strong emphasis on career development, offering abundant opportunities for growth. Regular interactions with our teams ensure their engagement, motivation, and recognition. We empower our team members to pursue their career goals with confidence and enthusiasm.
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.
Flexible Opportunities: At GlobalLogic, we prioritize work-life balance by offering flexible opportunities tailored to your lifestyle. Explore relocation and rotation options for diverse cultural and professional experiences in different countries with our company.
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.
