Software Quality Assurance Manager

7 days ago

Stockholm, Stockholm, Sweden Panda International Full time

Software Design Quality Lead

Location: Stockholm / Berlin (Hybrid)

We are seeking a Software Design Quality Lead to define and drive software quality assurance across our medical device ecosystem. This role is central to shaping software quality frameworks, influencing engineering teams, and supporting rapid organizational scale.

You will own software design controls, SDLC documentation, risk management, and audit-ready technical files for embedded, application, cloud, and AI systems. Working closely with software, firmware, and product leaders, you'll ensure development is safe, efficient, and compliant with global standards.

With foundational systems in place, the focus now shifts to scaling, system-building, and automation. You'll begin with 1 - 2 direct reports and grow a dedicated Software QA team. Beyond compliance, this role requires a strategic mindset, balancing quality, innovation, and development velocity.

What You'll Do

  • Define and execute the software QA strategy across all product areas.
  • Lead, mentor, and grow a high-performing Software QA team.
  • Own software design control, SDLC quality, and risk management in compliance with MDR and FDA.
  • Maintain audit-ready Software Development Files, risk documentation, and V&V outputs.
  • Implement digital tools, automation, and CI/CD-integrated QA workflows.
  • Establish KPIs and data-driven quality metrics for SDLC performance.
  • Collaborate with software, firmware, data, and product teams to ensure quality across development.
  • Contribute to architecture reviews, hazard analysis, and system-level design controls.
  • Prepare the organization for audits and inspections.
  • Promote a culture of quality excellence across R&D.

Who You Are

  • 8+ years in Software QA or Software Design Quality within regulated medtech or digital health.
  • Proven leadership experience building and managing QA teams.
  • Strong expertise in software design controls, risk management, and regulated SDLC.
  • Knowledge of MDR, FDA 21 CFR 820/11, and standards including:
  • IEC 62304, ISO 14971, IEC 62366, IEC , IEC , ISO plus).
  • Experience producing audit-ready software documentation.
  • Skilled in designing scalable QA processes using automation and DevOps tooling.
  • Excellent communicator with strong cross-functional collaboration skills.
  • BSc/MSc in Software Engineering, Computer Science, Biomedical Engineering, or similar.
  • Fluent in English

Nice to Have

  • Experience with AI/ML devices, cloud platforms, or automated quality systems.
  • Background in scaling QA in high-growth tech environments.
  • Supplier software quality or external lab coordination experience.
  • Participation in industry or regulatory working groups.

Apply

Ready to make your mark? Don't hesitate to apply today as first round interviews will be arranged for the first week of Jan.

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