Senior Software QA Engineer I

ESSENTIAL FUNCTIONS PERFORMED

• Develops and maintains software quality plans aligned with design controls and global regulatory requirements.
• Ensures compliance with 21 CFR 820.30, ISO 13485, and internal procedures.
• Leads software risk analysis (FMEA, hazard analysis, fault-tree analysis) and CSA risk activities
• Reviews and approves protocols, traceability matrices, and reports; requirements for clarity, completeness, and testability.
• Evaluates and qualifies software suppliers (audits, risk-based assessments).
• Leads investigations for software-related issues and field events.
• Ensures robust change management, impact analysis, and regression strategies.
• Partners on vulnerability management, secure design, and patching strategies.
• Supports trending, field analysis, and risk updates for released software.
• Performs other duties, as assigned.

ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS

•           Lifting -- Not to exceed 50 lbs. – local practice may apply.

•           Writing

•           Sitting

•           Standing

•           Bending

•           Visual acuity

•           Reading

•           Field of vision/peripheral

SUMMARY OF MINIMUM QUALIFICATIONS

• Education and/or experience equivalent to a Bachelor’s degree in relevant engineering discipline.
• A minimum of eight (8) years of experience in software assurance or regulated software development.
• Strong knowledge of: IEC 62304, ISO 14971, ISO 13485, 21 CFR Part 820 / QMSR
• FDA software validation and CSA guidance
• Experience with requirements/tools (e.g., Jira, Monday.com)
• Ability to interpret architecture, code structure, and test coverage

PREFERRED QUALIFICATIONS

• Experience in Class II or Class III medical devices.
• Experience with AI/ML in regulated environments.
• Experience with cyber-security standards (e.g., UL 2900).
• Certifications such as ASQ CSQE, ISTQB, Certified Quality Engineer (CQE)
• Experience in independently performing Advanced Operations or manufacturing software validation.