QA Engineer I in Naarden, Nederland

Quality Assurance Engineer I at Thermo Fisher Scientific's Naarden site, responsible for maintaining and improving the Quality Management System, reviewing batch records, managing deviations in a GMP environment, and supporting customer projects for affinity resin manufacturing.

Responsibilities

• Maintain and continuously improve the Quality Management System
• Review batch records, generate Certificates of Analysis, and release products
• Register and review root cause investigations of deviations and complaints in TrackWise
• Support customer problem-solving initiatives to improve efficiencies and satisfaction
• Address customer inquiries regarding product specifications and compliance

Requirements

• HBO degree in Chemistry, Biology, Biotechnology, Engineering, or related field
• 3+ years Quality Assurance experience or Master's degree in relevant discipline
• Experience with ISO 9001 or GMP quality management systems
• Proficiency with Document Management Systems and TrackWise software
• English language competency at HBO/scientific level
• Strong knowledge of quality standards including cGLP, GMP, and ISO 9001
• Problem-solving and independent work capability with cross-functional collaboration skills