Senior Software Quality Engineer
Skills
Agile MethodologiesAgile TestingAutocadC++DatabasesHP Quicktest ProfessionalJenkins
What the job involves
The main requirements, responsibilities and hiring steps.
Requirements
- Regulated software quality engineering experience
- Medical device software or SaMD or SiMD experience
- Knowledge of IEC 62304 software lifecycle expectations
- Experience with software design controls
- Risk-based software validation and verification documentation
- Requirements and test management systems experience
- End-to-end traceability from user needs through validation
- Defect classification investigation and trending experience
- Software configuration management and change control
- Cybersecurity data integrity audit trails or event logging knowledge
- SOUP third-party software or open-source software risk experience
- Agile development within a design control framework
Nice to have
- Strong communicator
- Cross-functional collaborator
- Detail-oriented
- Mentoring ability
Day to day
- Develop and execute software validation strategies for regulated medical device systems.
- Maintain end-to-end traceability from user needs through requirements verification and validation.
- Partner with engineering and cross-functional teams to support release readiness and lifecycle documentation.