Staff Quality Systems Specialist I
Core
Develops and maintains quality system procedures, leads CAPA and audit activities, and manages quality notifications for medical device manufacturing.
Role type
Staff Quality Systems Specialist (Medical Device)
Builds
Site quality management systems, CAPA processes, and audit compliance frameworks
Domain
Medical Technology / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
US and International medical device regulations (21CFR820, ISO 13485, MDD/MDR, MDSAP), CAPA management, internal and external audit execution, root cause analysis, quality metrics analysis, policy and procedure development
Preferred skills
Cross-functional collaboration, problem-solving coaching, trend analysis
Technologies
Trackwise, electronic audit tools, QN management systems
Responsibilities
Develops site/unit procedures and work instructions; Leads site CAPA Board meetings and acts as CAPA Subject Matter Expert; Serves as site Audit Manager ensuring internal and external audit requirements are met; Coordinates Quality Notifications (NCs and Planned Deviations); Tracks and analyzes quality data trends (CAPA, Audits, QNs); Supports pre- and post-inspection activities; Collaborates with cross-functional partners on policy development and quality issue resolution
Seniority
Staff, hands-on IC with strategic oversight