Quality Engineer

We are seeking a Quality Engineer with expertise in Validation & Automation to join a growing quality team supporting system, method, and process validation across the full product lifecycle. This permanent position plays a vital role in maintaining a validated and compliant state for manufacturing, laboratory, and automation systems in a regulated environment.

As a core member of the QA team, you will help shape validation strategy and contribute to improvement projects related to IVD software, equipment qualification, and system implementation.

Company Description

You’ll be joining an established diagnostics organization active in both protein- and viral-based technologies. Known for its scientific rigor and strong quality culture, the company is entering a growth phase driven by increasing international demand and expanded third-party collaboration. The team values openness, cross-functional teamwork, and a practical approach to complex challenges.

Essential Requirements

• At least 5 years of experience in a GxP-regulated environment, preferably within QA in the pharma, biotech, or medical device industry
• Minimum 5 years of hands-on experience with validation (e.g., equipment, systems, methods, software)
• Strong understanding of global validation standards and design control requirements
• Solid knowledge of software-related regulatory frameworks (e.g., IVDR, FDA guidance)
• Experience with production, QC processes, utilities, and project coordination
• Excellent technical documentation and review capabilities
• Fluent in Dutch and English
• Structured, pragmatic, and collaborative working style

Desirable Qualities

• Experience with process validation
• Familiarity with electronic QMS tools (training systems, CAPAs, complaints)
• Ability to write user requirements and validation documentation from scratch
• Comfortable leading or supporting cross-functional projects
• Straightforward communication style and a strong team mindset

Additional Insights

Location: Ghent area, Belgium (on-site with some flexibility)

Contract type: Permanent, full-time

Start date: As soon as possible