Lead Software Quality Assurance Analyst IRC

Description

We are looking for an experienced Software Design Quality Assurance Lead to partner with our R&D organization on 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 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.

• 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 Master's Degree in engineering field is highly desirable.
• Exceptional problem‑solving skills.
• Ability to understand 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.

• 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 compliant 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 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…