What are the responsibilities and job description for the Senior Software Quality Engineer position at Accordance Search Group?
Our client is looking for a Senior Technical Software Quality Engineer for software-enabled medical device systems. The position is remote but the ideal candiate should live within a 3 hour driving distance to the company midwestern sites in Illinois and Wisconsin. The ideal candidate needs regulated software quality experience, preferably with medical device software, SaMD, SiMD, connected healthcare systems, or other highly regulated software environments.
Ideal candidate background:
- Software quality engineering in a regulated environment
- Medical device software, SaMD, or SiMD
- IEC 62304 software lifecycle expectations
- Software design controls
- Risk-based software validation
- Software verification and validation documentation
- Requirements and test management systems
- End-to-end traceability from user needs through validation
- Defect classification, investigation, and trending
- Software configuration management and change control
- Cybersecurity, data integrity, audit trails, or event logging
- SOUP, third-party software, or open-source software risk
- Agile development within a design control framework
Strong indicators of fit
A strong candidate should be able to explain examples of:
- Developing or executing software validation strategies
- Maintaining traceability from user needs to requirements, verification, and validation
- Supporting IEC 62304 or similar regulated software lifecycle documentation
- Performing risk-based testing, regression testing, negative testing, or edge-case testing
- Supporting software release readiness
- Working with software engineering, systems engineering, product, clinical, manufacturing, and external partners
Preferred qualifications
- Medical device software experience
- SaMD or SiMD experience
- Connected device, cloud platform, mobile app, or data infrastructure validation experience
- Experience with IEC 62304, ISO 14971, ISO 13485, IEC 62366, or IEC 81001-5-1
- Experience aligning Agile practices with design control requirements
- Experience mentoring or providing technical guidance to other quality or engineering team members
Travel less than 10% to local sites in IL and WI.