Quality Engineer

Thermo Fisher Scientific seeks a Quality Engineer in Oslo to ensure products, processes, and quality systems meet regulatory standards. The role involves supporting new product introductions, managing risk assessments, leading investigations, and driving continuous improvement across the organization.

Responsibilities

• Ensure compliance with applicable quality standards and regulatory requirements
• Lead Design Compliance and Quality activities in New Product Introduction projects
• Conduct risk assessments and develop appropriate mitigation strategies
• Support validation and qualification of instruments, software, processes, and analytical methods
• Investigate deviations with cross-functional teams, perform root cause analyses, and support corrective actions

Requirements

• Advanced degree in Life Sciences, Engineering, Chemistry, Biology, or related technical field
• At least 3 years of quality assurance or quality control experience in regulated industry
• Strong knowledge of GMP/GxP requirements and ISO standards (9001, 13485)
• Experience with validation, qualification activities, CAPA, and deviation management
• Demonstrated proficiency in root cause analysis, risk assessment, and investigation methodologies
• Fluent communication skills in Norwegian and English, written and spoken
• Experience with quality management systems software and Microsoft Office