Job Title: Quality Engineer Location: Brussels Role Type: Onsite/Hybrid Salary: Up To €70,000 Overview: The Quality Engineer ensures the qualification and maintenance of manufacturing equipment, utilities, facilities, and automated systems, guaranteeing compliance with regulatory standards and maintaining a state of validated operations. Key Responsibilities: Execute, plan, coordinate, and follow up on qualification and validation activities for equipment, systems, and facilities (e.G., HVAC, QC equipment, automation). Develop, write, and implement qualification-related SOPs, protocols, work instructions, templates, and tools. Maintain the qualified status of equipment through periodic review, change control, and requalification. Support harmonization of qualification strategies and processes. Stay up-to-date with international regulations and guidelines (e.G., cGMP, Part 11, ISO 13485, 21 CFR 820) and apply knowledge to improve qualification practices. Serve as a spokesperson during internal and external audits regarding equipment and system qualification. Requirements: Master’s degree in engineering, pharmacy, or equivalent experience. 3+ years in pharmaceuticals, medical devices, diagnostics, or highly regulated manufacturing. Strong technical writing and documentation skills. Analytical, process-oriented, and self-organized with technical understanding of manufacturing assets. Experience with diagnostic/IVD manufacturing, regulatory audits (FDA, FAGG), and qualification/validation standards is a plus. Proficiency in MS Office and ability to adapt, communicate clearly, and work under pressure.