Agile Quality Analyst
The Agile Quality Analyst or Software Verification Engineer is responsible for leading software quality processes and generation of the documentation set to meet software standards in general, with specific attention to IEC62304. They review software designs provided by the Solution Architect and code implementations to ensure the Software Validation and Verification to pass the requirements. They provide guidance in regards to test automation to fulfill regulatory needs. They shall adhere to the applicable medical regulatory and quality standards, including GxP guidelines and verification practices.
- Be a pivotal part of Rangle's growing team in Amsterdam and helping define the technical landscape within our teams
- Rangle provides great opportunities for personal growth in team, organizational, and technology leadership in a deeply lean/agile operating model.
- There's many pathways for growth, and opportunities internally
Details About Your Role
- Create and maintain the documentation to support the IEC62304 standard and the medical regulations in general
- Contribute to and leverage ISO13485-compliant QMS for development of SaMD
- Review software design and implementation, to ensure compliance with regulatory requirements
- Develop the verification test plans and implement the test scenarios to support TDD observing IEC62304 and other regulatory requirements
- Establish reliability plans and methodologies to evaluate products using industry-recognized reliability tools and standards
- Interface and collaborate with external Quality and Engineering teams
- Identify product failure symptoms, work with client and internal teams to identify the root cause
- Support knowledge transfer sessions
- Provide consulting in regards to software as a medical device (SaMD) and its regulatory requirements
What You Bring To The Team
- Applicable degree in software engineering or equivalent experience
- At least 4 years of experience developing patient and/or HCP SaMD solutions
- Experience working with IEC62304 standard
- Desirable, knowledge and experience working on products meeting ISO14971, ISO270001 and ISO13845 standards
- Understanding of good engineering practices in software (required), and hardware (nice to have)
- Problem-solving and debugging skills
- Knowledge of dynamic and static software analysis, requirements traceability
- Experience developing UML diagrams
- Experience with verification and validation software phases
- Desirable experience testing software for IEC61508 compliance
- Experience using GIT for code version control
- ASQ or ISO 9001 Certification is a plus
While focusing on doing the right thing, we adopt an atmosphere of creativity, belonging, and fun. Ranglers are curious, brave, kind, and innovative. Together we build experiences that make an impact on the world. Come join us.
Rangle is an equal opportunity employer committed to creating a safe, diverse and inclusive environment. We encourage qualified applicants of all backgrounds including ethnicity, religion, disability status, gender identity, sexual orientation, family status, age, nationality, and education levels to apply. If you are contacted for an interview and require accommodation during the interviewing process, please let us know.
Don't currently tick all the boxes?
We’re a culture of growth. If you're excited about this role, have most of the skills, and can learn the rest, please apply!