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.