The Staff QA Analyst serves as a recognized Subject Matter Expert for CAPA, Nonconformance, Complaint Handling, and Health Hazard Assessment within the Quality Management System
Job Summary
The Staff QA Analyst serves as a recognized Subject Matter Expert for CAPA, Nonconformance, Complaint Handling, and Health Hazard Assessment within the Quality Management System.
This role leads complex investigations and acts as a coach to strengthen investigation quality, risk-based thinking, and regulatory robustness across the team without formal people management.
The position requires advanced analytical skills to perform trending of quality data using Power BI and present data-driven insights to leadership forums.
Matching Summary
The Staff QA Analyst serves as a recognized Subject Matter Expert for CAPA, Nonconformance, Complaint Handling, and Health Hazard Assessment within the Quality Management System.
Skills & Requirements
Must-have
CAPA leadership and coaching
Health Hazard Assessment coordination
Complex complaint investigation
Power BI data analysis
ISO 13485 regulatory knowledge
FDA QSR 21 CFR 820 compliance
Nice-to-have
Lean Six Sigma certification
Root Cause Analysis expertise
eQMS platform experience
Software validation knowledge
Cross-functional influence skills
Key Requirements
Bachelor's degree in Engineering, Science, or related field
Minimum 10 years in Quality Assurance within regulated medical device environment
Demonstrated experience coaching others in investigation quality
Strong working knowledge of ISO 13485 and FDA QSR
Advanced analytical skills using Power BI or Excel