Lead Software Quality Assurance (SQA) Engineer Offline

Job Description:

• 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.

Department/Project 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.