Sr. Software Quality Assurance Engineer I
Core
Ensures software products for insulin pumps are developed, validated, and maintained in compliance with quality system and regulatory requirements.
Role type
Senior Software Quality Assurance Engineer (Medical Device)
Builds
Tandem Mobi system and t:slim X2 insulin pump with Control-IQ+ technology
Domain
Medical device / Diabetes technology / Regulated software
Deliverable
production ML models | product features | dashboards & analysis
Required skills
Software lifecycle development, quality processes, risk management, Design Controls, software verification and validation, software anomaly management, traceability analysis, regulatory compliance (FDA/ISO), process improvement
Preferred skills
Application lifecycle management, defect tracking tools, JavaScript, C
Technologies
JavaScript, C, Microsoft Office
Responsibilities
Serve as quality representative on project core teams; review and approve design control deliverables; participate in risk management activities; provide traceability analysis and reporting; oversee software anomaly management; review software verification and validation activities; participate in design reviews; support maintenance of Design and Development File; provide quality input to software changes and releases; evaluate quality-related process improvements; support Complaint, Field Investigation, and CAPA investigations; provide quality support during audits and inspections.
Seniority
Senior, hands-on IC
