Quality Associate II - Onsite Weekdays
Core
Ensuring compliance with medical device regulations and corporate processes, managing audits, and overseeing quality management systems.
Role type
Quality Compliance Associate
Builds
Quality Management System compliance and audit readiness for medical device manufacturing
Domain
Medical Devices / Healthcare Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory compliance interpretation, audit lifecycle management, SOP development, risk management, root cause analysis, CAPA management, document control, KPI analysis
Preferred skills
MS in science/engineering, audit experience, knowledge of ISO 13485, FDA QSR 21 CFR Part 820, risk management tools, statistical analysis
Technologies
Microsoft Office Suite
Responsibilities
Manage site certifications and external registration requirements; Lead audit readiness efforts and manage internal audit programs; Write, review, and revise Standard Operating Procedures (SOPs); Support failure investigation activities and approve CAPA projects; Maintain inventory and lifecycle management of stored records; Provide training and coaching on quality compliance.
Seniority
Mid-level, hands-on IC
