Senior Software Quality Engineer
Core
Lead and support quality and compliance activities for Non-Product Software used in support of the Quality Management System (QMS) and manufacturing processes.
Role type
Senior Software Quality Engineer (Regulated Industry)
Builds
Verified, validated, and compliant software systems for medical device manufacturing and quality management.
Domain
Medical Devices / Life Sciences / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Software Validation, Risk Management, Regulatory Standards (21CFR820, 21CFR11, ISO 13485), Change Control, Data Integrity, Electronic Records/Signatures, SDLC Processes, Impact Assessment, Audit Support
Preferred skills
Quality Engineering Principles, Software Testing, System Validation, New Technologies (AI/ML, Cybersecurity, Cloud)
Technologies
Camstar, LIMS, SAP, ETQ
Responsibilities
Review and approve Software Validation deliverables (URS, FS, CS, Risk Assessments, Validation Plans, Test Protocols, Reports), Lead software assessments and classification, Ensure validation activities follow applicable regulations, Lead software risk management activities for non-product software, Develop and conduct training on Software compliance, Support Data Management and Supplier Management activities, Participate in strategic/technical discussions and risk-based decision making, Support the change control process by performing impact assessments, Support and facilitate internal and external audits
Seniority
Senior, hands-on IC with leadership responsibilities