Quality Assurance Assistant
Core
Review manufacturing and quality documentation, lead nonconformance investigations, support inspections, and create quality dashboards for medical device product release and compliance.
Role type
Senior IC Quality Assurance Specialist (Medical Devices)
Builds
Quality dashboards, automated workflows, and validated quality records for medical device manufacturing.
Domain
Medical Devices / Regulatory Quality
Required skills
Root-cause analysis, CAPA management, complaint investigation, SOP revision, audit support, data integrity, ISO 13485, EU MDR, ERP systems, workflow automation, Power BI, advanced Excel, AI-enabled tools
Preferred skills
Dental materials knowledge, chemical-based medical devices, validated computerized systems, statistical trending, FDA requirements, Six Sigma, lead auditor
Technologies
Power BI, Power Automate, Copilot, Oracle, ERP systems
Responsibilities
Review and dispose of Device History Records and batch records; lead investigations of nonconformances and customer complaints; support incoming, in-process, and final inspections; interpret lab results and oversee calibration; revise SOPs and support change control; participate in internal and external audits; create quality dashboards and automated workflows; communicate quality metrics to stakeholders.
Seniority
Senior, hands-on IC