Sr. Analyst, Quality Systems
Core
Owns and advances key Quality Systems (Training, Document Control, Change Control, Management Review, Quality Audits) to ensure compliance with medical device regulations and drive inspection readiness.
Role type
Senior Quality Systems Analyst (Medical Device)
Builds
Site Quality Management System (QMS) aligned with ISO 13485 and FDA regulations
Domain
Medical Device Manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical device regulations (FDA, ISO 13485, 21 CFR 820), Quality Management System (QMS) management, Document Control, Change Control, Audit coordination, Management Review facilitation, Nonconformance record management, SOP authoring, Data-driven improvement analysis, Cross-functional collaboration, Project management
Preferred skills
CQA or ISO 13485 Auditor certification, GMP/GDP application, Root cause analysis, Mentoring
Technologies
ISO 13485, FDA regulations, 21 CFR 820, GMP, GDP
Responsibilities
Own and continuously improve the site Quality Management System (QMS); Lead document control excellence; Manage and enhance the training program; Ensure site-wide compliance readiness by coordinating audits; Lead Management Review processes; Own the Change Control process; Develop and monitor Quality System metrics; Initiate and own nonconformance records; Plan and execute internal and external audits; Drive cross-functional collaboration to resolve compliance gaps; Supervise team members
Seniority
Senior, hands-on IC