Software Design QA Manager - Stockholm, Stockholm County

Endast för registrerade medlemmar Stockholm, Stockholm County, Sverige

för 3 dagar sedan

Software Design Quality Manager · Location: · Hybrid with proximity to one of the three office hubs · Physical Office Hubs: · Stockholm / London / Berlin · Employment Type: · Full-time · We are seeking a People Lead for Software Design Quality Assurance to define, scale, and cont ...

Jobbbeskrivning

Software Design Quality Manager

Location:
Hybrid with proximity to one of the three office hubs

Physical Office Hubs:
Stockholm / London / Berlin

Employment Type:
Full-time

We are seeking a People Lead for Software Design Quality Assurance to define, scale, and continuously improve software quality across a regulated medical device software ecosystem. This role is accountable for software design controls, SDLC quality systems, risk management, and audit-ready technical documentation spanning embedded software, applications, cloud platforms, SaaS, and AI/ML-enabled systems.

You will work closely with software engineering, firmware, cloud, DevOps, data, and product leadership to ensure software development is safe, compliant, efficient, and scalable. With foundational quality systems already in place, the emphasis is now on system-building, automation, and organizational scaling.

This is a hands-on leadership role requiring strong regulatory expertise, an engineering mindset, and the ability to balance quality rigor with development velocity. You will initially manage a small team and grow a dedicated Software Design QA function over time.

What You'll Do

Define and execute the software design QA strategy across all product areas, including SaMD, cloud-based platforms, and AI-enabled systems
Own software design control processes, SDLC governance, and risk management aligned with global regulatory requirements
Lead, mentor, and scale a high-performing Software Design QA team
Maintain audit-ready Software Design History Files (DHFs), risk management files, V&V documentation, and SOUP documentation
Establish and monitor SDLC quality KPIs and metrics to drive data-informed decisions
Implement automation, digital tooling, and CI/CD-integrated quality gates to enable continuous compliance
Collaborate with engineering and product teams on architecture reviews, hazard analysis, cybersecurity, and system-level design controls
Ensure organizational readiness for regulatory audits and inspections
Promote a strong culture of quality excellence across R&D while supporting rapid development and scale

Required Skills & Experience

8+ years of experience in Software Design Quality within the medical device or digital health industry, including SaMD, cloud-based software, and AI/ML-enabled systems
BSc or MSc in Computer Science, Software Engineering, Biomedical Engineering, or a related technical field
Proven leadership experience building and managing QA teams, with strong mentoring and people development skills
Deep expertise in software design controls and risk management for medical devices, with hands-on experience applying IEC 62304, IEC 82304, ISO 14971, EU MDR, and FDA 21 CFR Part 820/11
Strong knowledge of medical device software, usability, quality, and cybersecurity standards (e.g., IEC 62366, ISO 13485, IEC
Demonstrated ability to produce and maintain audit-ready software documentation, including DHFs and SOUP management
Experience implementing automated and DevOps-integrated QA processes, CI/CD quality gates, and modern QA tooling
Strong cross-functional collaboration skills within Agile software development environments
Analytical and strategic mindset with the ability to balance risk, compliance, quality, and development velocity
Excellent written and verbal communication skills in English

Nice to Have

Experience with
AI/ML validation and verification
for medical devices
Background scaling
cloud-native QA functions
in high-growth or agile organizations
Strong knowledge of
cloud platforms (AWS, Azure, GCP)
and SaaS regulatory considerations
Experience with
containerization, infrastructure-as-code, and cloud-native architectures
Experience working with
Notified Bodies or regulatory authorities
for software-driven medical devices

Apply

Ready to make your mark? Don't hesitate to apply today as first round interviews will be arranged within a week.