Senior QA/RA officer

Ver: 155

Día de actualización: 16-11-2025

Ubicación: Heverlee Flemish Brabant

Categoría: IT - Software IT - Hardware / Redes Tecnologías de la información

Industria:

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Contenido de trabajo

Supporting QA&RA manager in driving Quality & Regulatory compliance while aligning overall organization to meet business needs & objectives
Maintaining Technical dossiers - including preparing necessary documentation - for all Quirem Medical’s products
Monitoring regulatory developments and assessing business impact with the Function Requirements: (education, experience, competences, etc.)
Leading/supporting initiatives to improve the quality and manufacturing efficiency of Quirem products.

Challenging projects based on your interests and skills
Personal follow-up and clear, transparent communication both before and after commencement of employment
Possibility to follow extra training
Inspiring network events and legendary after work drinks
Strong network of industry leading clients
Expertise within IT, Engineering and Life Sciences
A flying start for every junior, growth opportunities and possibility to share gathered knowledge for more senior employees

BSc/MSc degree or higher in science, engineering, medicine or a related field with 1+ years of relevant experience in medical device or 4+ years in pharma/biotechnology in a QA&RA function.
Knowledge of medical devices regulatory frameworks including MDR, AIMDD, MDD and standards like the ISO 13485:2016 as well as other applicable global regulatory frameworks and standards.
Familiar with Medical Devices Software product development and technical dossiers.
Knowledge of medical device software standards like 1EC62304.
Project management experience.
Working in multidisciplinary and international teams.
Ability to work with different software packages and a document management system (SmartSolve).
Excellent interpersonalskills and communication skills, written and oral, in English
Motivated and accurate.
Striving for optimal quality in own work and that of others.
Demonstrates ownership and curiosity and continuously looking for improvement without losing practicality out of sight.
Likes organizing and providing structure. Flexible whenever the ’dynamics’ of the job ask for it.

Reference number: 37119

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