Lead Software Quality Assurance Analyst IRC281839

職種概要

We are looking for an experienced Software Design Quality Assurance Lead to partner with our R&D organization on developmen of software as a medical device product.

You 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) and drive assosiated QMS improvements in case of need.

You will collaborate with R&D and product management teams to ensure robust quality processes and regulatory compliance.

This role is critical for ensuring patient safety, product effectiveness, and successful regulatory submissions

必要条件

• Significant experience (7+ years) in Software Design 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 SDQA/QE role 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 in 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.
• Cybersecurity, electro-mechanical and usability engineering experience is a huge plus.
• Bachelor’s or Marter’s Degree in engineering field is highly desirable.
• Exceptional problem-solving skills.
• Ability to understands and subsequently explain complex quality details to non-experts.
• Excellent written and verbal communication skills.
• Ability to work effectively cross-functionally and manage competing priorities.
• Exceptional organizational skills.

職務内容

 

• Define and adapt software development lifecycle (SDLC) processes to ensure compliance with IEC 62304 and other applicable standards within Agile or hybrid frameworks.
• Ensure all project activities from requirements through release are comply with established QMS and regulatory requirements.
• Review and approve key software lifecycle documentation (plans, requirements specifications, risk documents, V&V documents, trace matrixes, usability engineering documents) to confirm completeness and compliance with quality standards and ensure documentation provides sufficient objective evidence of compliance and quality.
• Oversee the entire software verification and validation (V&V) process to ensure comprehensive requirements coverage, provision of V&V objective evidence and maintaining full end-to-end traceability to confirm the safety, security and effectiveness of the software.
• Lead and facilitate software risk management in accordance with ISO 14971, ensuring risks are identified, controlled, verified, and properly documented.
• Ensure software configuration and change management compliance.
• Oversee computerized system validation process and review respective deliverables.
• Act as the Quality representative on cross-functional development teams.
• Mentor project team members (including developers, testers, BAs) on QMS procedures, regulatory requirements, and quality best practices. Provide training on relevant SDQA topics and standards as needed.
• Drive continuous process improvement initiatives to improve efficiency and effectiveness while maintaining compliance.
• Lead and conduct internal audits of software development processes and documentation to verify compliance and drive continuous improvement.
• Act as the primary SDQA contact during external audits and regulatory inspections related to software development.

Why Join Us

We offer a fast-paced, collaborative, and innovative environment dedicated to improving healthcare quality and the patient experience.
If you’re passionate about excellence in design quality and compliance, we invite you to join our team.

 

#LI-ZK1 #LI-Remote

 

私たちが提供するもの

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.

GlobalLogicについて

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.