Lead Software Quality Assurance Analyst IRC281839

Lead Software Quality Assurance Analyst IRC

Join to apply for the Lead Software Quality Assurance Analyst IRC role at GlobalLogic .

We are looking for an experienced Software Design Quality Assurance Lead to partner with our R&D organization on the development 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 associated QMS improvements when needed.

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.

Responsibilities

• 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 comply with established QMS and regulatory requirements.
• Review and approve key software lifecycle documentation (plans, requirements specifications, risk documents, V&V documents, trace matrices, usability engineering documents) to confirm completeness and compliance with quality standards.
• 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.
• 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.

Requirements

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