Staff QA Engineer

What this role involves

The Staff QA Engineer role at Thermo Fisher Scientific focuses on ensuring product quality and regulatory compliance in a regulated environment. Responsibilities include conducting audits, managing validation activities, and supporting quality initiatives. The position requires strong knowledge of GMP, ISO standards, and regulatory requirements, with a minimum of 6 years of experience for advanced degree holders or 8 years for bachelor's degree holders.

Skills this posting asks for

• gmp
• iso 9001
• iso 13485
• fda
• ema
• audits
• capas
• change control
• document control
• risk management
• fmea
• root cause analysis
• statistical analysis
• iq/oq/pq
• process validation
• computer system validation
• project management
• trackwise
• sap
• data integrity
• computer system compliance

Requirements

• 6 years of experience
• Level: staff
• Remote policy: onsite