Staff QA Engineer

Staff QA Engineer at Thermo Fisher Scientific in Greenville, NC, responsible for ensuring product quality and regulatory compliance. The role involves auditing, validation activities, quality system management, and cross-functional collaboration to support life-science operations.

Responsibilities

• Conduct internal and external audits, including regulatory inspections and client audits
• Manage validation activities and quality system processes across operations
• Lead cross-functional teams on quality initiatives and continuous improvement
• Review and approve technical documentation, protocols, and reports
• Support a culture of quality excellence aligned with company mission

Requirements

• Advanced degree plus 6 years QA experience, or bachelor's degree plus 8 years in regulated environments
• Strong knowledge of GMP regulations, ISO 9001/13485, and regulatory requirements (FDA, EMA)
• Experience conducting internal/external audits and regulatory inspections
• Expertise in CAPA, change control, document control, and risk management systems
• Proficiency with quality tools: FMEA, root cause analysis, statistical analysis
• Experience with IQ/OQ/PQ, process validation, and computer system validation
• Proficiency with quality management software (TrackWise, SAP, or equivalent)