Lead Software Quality Assurance (SQA) Engineer IRC264304

Description

We are partnering with a global leader in medical devices to develop the next-generation cutting-edge tool used during hip arthroscopy for femoroacetabular impingement (FAI). Client provides surgeons with real-time visualization and measurement capabilities by superimposing virtual tools on X-ray images, enabling precise clinical decision-making. The product will help surgers to plan and to validate the procedures by analyzing 2D images from X-Rays, CT, MRI and building 3D objects.

Our goal is to enhance the product’s capabilities, improving workflow efficiency and advancing surgical outcomes. This project will involve refining requirements, designing intuitive interfaces, and integrating advanced visualization tools to meet the highest clinical standards. Join us in shaping the future of minimally invasive orthopedic surgery.

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Requirements

– Bachelor’s degree or higher in Engineering (Software, Biomedical, Electrical), Computer Science, Life Sciences, or a closely related technical field.

– Significant experience (typically 7+ years) in Software Quality Assurance or Quality Engineering roles specifically within the medical device industry, working with Software as a Medical Device (SaMD).

– Proven experience in a Lead SQA/QE role, demonstrating leadership in quality strategy, process implementation, and team guidance for software projects.

– Deep understanding and extensive practical application of relevant medical device standards and regulations: ISO 13485, IEC 62304, ISO 14971, FDA Quality System Regulation (21 CFR Part 820), and preferably EU MDR/IVDR requirements for software.

– Strong proficiency in Software V&V methodologies, Risk Management techniques (FMEA, FTA), Design Controls, Root Cause Analysis, CAPA processes, Auditing techniques (internal/external), Documentation review. Strong proficiency of SDLC models (Agile, Waterfall, Hybrid), Configuration Management principles, Change Control processes, Traceability tools/techniques.

– Experience conducting or participating in internal/external quality audits. Experience reviewing and approving software lifecycle documentation within a QMS.

– Experience with software involving complex algorithms, AI/ML components, or advanced visualization (2D/3D) is a big plus. Experience with usability engineering for medical devices (IEC 62366).

– Medical device SQA principles, QMS implementation, ISO 13485, IEC 62304, ISO 14971, FDA QSR Part 820 (and relevant guidance documents).

– Familiarity with software development concepts, programming languages (e.g., C++ used by the team), automated testing concepts, usability engineering (IEC 62366).

– Excellent analytical skills and meticulous attention to detail. Strong leadership, influencing, and decision-making skills. Excellent written and verbal communication skills. Ability to work effectively cross-functionally and manage competing priorities.

– Relevant certifications like ASQ CSQE (Certified Software Quality Engineer), ASQ CQA (Certified Quality Auditor), or others are a plus.

Job responsibilities

GlobalLogic is starting a completely new engagement and looking for Lead Software Quality Engineer (SQA) who will establish, lead, and oversee all Software Quality Assurance activities throughout the product lifecycle, ensuring the software development processes and the final product comply with internal Quality Management System (QMS) requirements, relevant medical device standards (e.g., ISO 13485, IEC 62304, ISO 14971), and applicable regulatory requirements (e.g., FDA QSR, EU MDR). This role is critical for ensuring patient safety, product effectiveness, and successful regulatory submissions.

– Develop, implement, and lead the project-specific Software Quality Assurance plan, aligning with the overall QMS and regulatory strategy. Establish quality objectives and metrics for the project and monitor performance against them.

– Define and tailor software development lifecycle (SDLC) processes for the project, ensuring compliance with IEC 62304 and other relevant standards within an Agile or hybrid framework.

– Ensure project activities (requirements, design, coding, testing, release) adhere to established QMS procedures, Design Controls, and regulatory requirements.

– Lead the review and provide SQA approval for key software lifecycle documentation, including but not limited to: Software Development Plan, Software Requirements Specifications, Software Architecture/Design Specifications, Risk Management File (Hazard Analysis, FMEAs), V&V Plans, Protocols, and Reports, Traceability Matrices, and Usability Engineering documentation (IEC 62366). Ensure documentation provides sufficient objective evidence of compliance and quality.

– Lead and conduct internal audits of software development processes and documentation to verify compliance and identify areas for improvement.
Act as the primary SQA point of contact during external audits or regulatory inspections related to software.

– Lead and facilitate software risk management activities according to ISO 14971 throughout the lifecycle. Ensure software hazards are identified, risks are assessed, control measures are implemented and verified, and the Risk Management File is maintained.

– Oversee the entire software V&V process, ensuring strategies and plans provide comprehensive coverage based on requirements and risks. Review and approve V&V protocols and reports, ensuring appropriate methodologies (manual, automated, usability) are used and results adequately demonstrate that requirements are met and the software is safe and effective.

– Collaborate with the Lead AQA Engineer to ensure automated testing strategies align with V&V evidence requirements. Ensure robust end-to-end traceability is established and maintained between user needs, requirements, design, code, risk controls, and V&V activities.

– Oversee or ensure compliance with software configuration management and change control processes. Oversee the software defect management process, ensuring non-conformances are properly documented, evaluated, tracked, and resolved.

– Mentor project team members (including developers, testers, BAs) on QMS procedures, regulatory requirements, and quality best practices. Provide training on relevant SQA topics and standards as needed.

– Drive initiatives to continuously improve software development and quality assurance processes for efficiency and effectiveness while maintaining compliance.

What we offer

Culture of caring. At GlobalLogic, we prioritize a culture of caring. Across every region and department, at every level, we consistently put people first. From day one, you’ll experience an inclusive culture of acceptance and belonging, where you’ll have the chance to build meaningful connections with collaborative teammates, supportive managers, and compassionate leaders. 

Learning and development. We are committed to your continuous learning and development. You’ll learn and grow daily in an environment with many opportunities to try new things, sharpen your skills, and advance your career at GlobalLogic. With our Career Navigator tool as just one example, GlobalLogic offers a rich array of programs, training curricula, and hands-on opportunities to grow personally and professionally.

Interesting & meaningful work. GlobalLogic is known for engineering impact for and with clients around the world. As part of our team, you’ll have the chance to work on projects that matter. Each is a unique opportunity to engage your curiosity and creative problem-solving skills as you help clients reimagine what’s possible and bring new solutions to market. In the process, you’ll have the privilege of working on some of the most cutting-edge and impactful solutions shaping the world today.

Balance and flexibility. We believe in the importance of balance and flexibility. With many functional career areas, roles, and work arrangements, you can explore ways of achieving the perfect balance between your work and life. Your life extends beyond the office, and we always do our best to help you integrate and balance the best of work and life, having fun along the way!

High-trust organization. We are a high-trust organization where integrity is key. By joining GlobalLogic, you’re placing your trust in a safe, reliable, and ethical global company. Integrity and trust are a cornerstone of our value proposition to our employees and clients. You will find truthfulness, candor, and integrity in everything we do.

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.