Senior Advance Quality Engineer
Core
Quality representative for New Product Development and sustenance of Software as a Medical Device (SaMD), ensuring compliance with medical device regulations and SDLC processes.
Role type
Senior IC quality engineer (medical device software)
Builds
SaMD and Non-Medical Software products compliant with FDA/ISO standards
Domain
Medical Devices / Healthcare Software
Required skills
Risk Management (ISO 14971), Quality Management Systems (ISO 13485, 21 CFR 820), Software Development Life Cycle (SDLC), Verification & Validation (V&V), Defect Management, Requirements Traceability, Root Cause Analysis, Cybersecurity concepts, Change Control
Preferred skills
Agile methodologies, Traditional SDLC methodologies
Technologies
Jira, Azure DevOps, Testrail, TrackWise, Salesforce, Slack
Responsibilities
Define quality and compliance requirements for SaMD development; Develop and execute software quality strategies, test plans, and validation approaches; Review and approve quality deliverables including traceability and test coverage; Support internal and external audits and manage CAPAs, non-conformances, and change controls; Validate SW tools used in development and deployment; Mentor junior quality engineers
Seniority
Senior, hands-on IC
