Sr. QA Software Engineer (ISO 13485)
About The Position
The Sr. QA Software Engineer provides expertise and guidance on policies and regulatory requirements to support compliance. The role partners with software development teams throughout the Software Development Lifecycle (SDLC), contributing to documentation such as development plans, verification and validation materials, requirements specifications, architecture and design documents, design and code reviews, software Risk Management Files (RMFs), test protocols and reports, and traceability matrices. The position participates in Quality Management System (QMS) activities in compliance with US FDA Quality System Regulations and ISO 13485, and supports software risk management, including cybersecurity risk, through collaboration and feedback to development teams. It stays current on regulations relevant to existing software, guides development teams in finding compliant solutions, and conducts testing to assess software effectiveness and accuracy against operating standards or performance guidelines. This role is fully onsite at the Irvine, California campus; remote and hybrid arrangements are unavailable.
Requirements
- Bachelor’s degree in Computer Science, Software Engineering, Informatics, Biomedical, or a related technical field, or equivalent education and/or experience demonstrating comparable knowledge, skills, and abilities.
- At least eight years of software engineering experience within the FDA QSR/ISO 13485 medical device industry.
- Experience applying IEC 62304 (Medical Device Software Lifecycle Processes), ISO 14971 (Risk Management), IEC 60601 (Medical Electric Equipment), and IEC 62366 Usability Engineering.
- Experience with Agile software development methodologies such as Scrum and Kanban.
- Experience in software development areas other than embedded software, such as web development.
Nice To Haves
- Previous experience with cloud-based software.
Responsibilities
- Provide expertise and guidance in interpreting policies, regulatory and governmental regulations, and internal regulations to assure compliance.
- Partner with software development teams on SDLC documentation, including development plans, verification and validation, requirements specifications, architecture and design documents, design and code reviews, RMFs, test protocols and reports, and traceability matrices.
- Participate in QMS activities in compliance with US FDA Quality System Regulations and ISO 13485.
- Participate in software risk management activities, including cybersecurity risk, by collaborating with and providing feedback to software development teams.
- Remain current on existing and new regulations to support compliance of existing software.
- Guide development teams in seeking solutions and alternatives that meet regulatory requirements.
- Conduct testing and assess software effectiveness and accuracy against operating standards or performance guidelines.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
