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Senior Software Quality Engineer
3 weeks ago
We are seeking a skilled professional to fill this key role in the development of medical devices. This opportunity allows someone with expertise in software quality assurance to apply their skills to contribute to meaningful technology.
Key Responsibilities:- Reviewing and approving technical documentation, including threat models, SBOMs, protocols, and architecture
- Maintaining risk assessments and traceability matrices for software compliance
- Collaborating with software engineers to ensure secure-by-design product development
- Supporting secure software development lifecycle and Cyber Security efforts (IEC 81001-5-1, ISO 14971, FDA Cybersecurity Guidance etc)
- Supporting general QA activities - including CAPA, change control, document review, and internal/external audits
- 5+ years in software quality engineering in similar highly regulated industries
- Experience with relevant standards and frameworks like IEC 62304, ISO 14971, IEC 81001-5-1, FDA QSR, ISO 13485, and relevant international guidance
- Some knowledge of cybersecurity risk frameworks is beneficial (e.g. NIST, ISO 27001)
- Exposure to supporting or contributing to CAPA Investigations / Root Cause Analysis, Audit readiness or similar is beneficial
This is an exciting opportunity for someone looking to grow their career in software quality assurance and contribute to the development of innovative medical devices.
Why you'll love this role:- Contribute to the development of life-changing medical devices
- Grow your skills and experience in software quality assurance
- Work with a talented team of professionals
- Make a meaningful impact on patient care
