QA Compliance Specialist

Trasis; Luik; Hybride; EUR 60 000 - 85 000; Plein temps

Résumé du poste

Trasis is seeking a QA Compliance Specialist to strengthen our quality management system and ensure adherence to ISO and GMP standards, customer requirements, and internal protocols. You will drive deviations, CAPA, change controls, and continuous improvement across the group.

You will collaborate with customers and subcontractors to ensure proper documentation and effective actions, contributing to cancer diagnostics technology advancements.

Qualifications

• Master's degree in a science-related field or equivalent experience.
• At least 5 years in a QA/compliance role.
• Strong knowledge of ISO and GMP standards.
• Fluent/excellent English communication.

Responsabilités

• Lead and manage external quality events (deviations, CAPA, change control) with customers and suppliers.
• Drive continuous improvement of the quality system and risk analyses.
• Communicate with customers on quality inquiries, complaints, and investigations.
• Ensure subcontractor quality documents are evaluated and tracked per requirements.
• Draft, review, and harmonize QMS procedures for group-wide use.
• Define KPIs for customer complaints and quality actions, and monitor improvement plans.

Connaissances

Analytical skills

Attention to detail

English proficiency

Self-reliant

Prioritization

Formation

Master’s degree in science

Equivalent experience

Description du poste

As a QA Compliance Specialist, you will contribute to ensuring compliance and the continuous improvement of the quality management system to meet regulatory requirements, quality standards, and internal procedures, as well as customer requirements, while promoting the harmonization and standardization of practices across the Group.

Responsibilities

• You will actively participate in managing external quality events (deviations, change control, CAPA) involving customers and suppliers by ensuring relevant investigations, robust analyses, effective actions, and their rapid implementation.
• You will contribute to the continuous improvement of the quality system by identifying opportunities to optimize processes, participating in product and process risk analyses, and providing your expertise to support decision-making.
• You will handle communication with customers on various quality-related matters (inquiries, complaints, investigations, major changes, etc.).
• You ensure that quality information provided by subcontractors (deviations, changes, production records, and other quality documents) is properly accounted for, guaranteeing that it is evaluated and tracked in accordance with quality requirements.
• You will contribute to drafting, reviewing, and improving both structural and operational Quality Management System procedures, ensuring their consistency, effectiveness, and—where relevant—harmonization for Group-wide implementation.
• You will participate in defining performance indicators related to customer complaints and associated quality actions, and ensure the communication and follow-up of the resulting improvement plans.

Profile

• You hold a master’s degree in a science-related field or have equivalent experience
• You have at least 5 years of experience in a similar role
• You have theoretical and practical knowledge of ISO and GMP standards
• You have an excellent command of English
• You are self-reliant, with strong analytical and synthesis skills
• You are meticulous, organized, and have a strong sense of priorities

Do you want to become a major player in the global fight against cancer?

At Trasis, we give you the opportunity to work with cutting-edge technologies and to contribute to the improvement of cancer diagnosis and therapy techniques. Through your actions, you will have the opportunity to have a positive impact on the services provided to users and patients.

The opportunity to participate in building and improving processes in a growing company.

We offer a young and friendly work atmosphere, a flexible and dynamic environment.

An attractive and flexible salary according to your experience and performance, with extra-legal benefits.