Operational Quality Engineer : labelling specialization

BALT Group; Montmorency; Sur place; EUR 40 000 - 60 000; Plein temps

Résumé du poste

BALT Group seeks a Labelling Specialist to manage labeling documentation for medical devices. The role involves collaboration with cross-functional teams to ensure compliance with regulatory standards and the development of effective labelling processes. Suitable candidates should hold a relevant degree and possess a minimum of 3 years of experience in a regulated environment.

Qualifications

• Minimum 3 years of labeling experience in an FDA or EU regulated environment.
• Fluent in English and French.
• Experience with label design software.

Responsabilités

• Design, develop and update global labeling documents.
• Ensure compliance with regulatory requirements and guidelines.
• Coordinate training for manufacturing personnel related to labeling.

Connaissances

Attention to detail

Collaboration

Problem solving

Formation

Bachelor's or master's degree in a scientific discipline

Outils

Easy Label

Nice Label

Bartender

Adobe Illustrator

Adobe Photoshop

Description du poste

Our purpose is to improve the lives of 150,000 patients in 2026.

Our story

Balt is a rapidly growing pioneer in an exceptional field. For 45 years, Balt has been leading the way - collaborating with physicians and institutions to develop elegant medical devices. Our products are being used by physicians across the world, and we have 13 offices in 11 countries - and counting.

We introduced one of the first neurovascular intervention devices in 1977 and now offer the world's broadest portfolio of medical devices for stroke. As the premier global neurovascular platform always seeking to expand beyond boundaries, we are now bringing our innovation to the peripheral vascular space.

We are proud of our mission, our people, and the incredible work we accomplish together as we empower physicians to save lives.

Why Join Balt? Join a passionate team, dedicated to making a difference.

• Working at Balt means giving meaning to your work! Pride is a strong part of our identity.
• We are a close-knit team, with strong mission, vision and values that guide our day-to-day.
• Recognition of work, respect, and our multicultural community are key aspects of the employee experience and contribute to our continued success.
• No matter the country, we take care of you.

Would you like to be part of story? Don't hesitate and come and join us.

About this opportunity

The Labelling Specialist is responsible for the overall coordination, development, and execution of labelling for commercialized and new product development products.

Job responsibilities :

I-Specific Labelling activities :

• Design, develop and update global labeling documents to include product labels, instructions for use (IFUs), implant cards, and other related labelling materials
• Collaborates with cross-functional team members to ensure the accuracy of all information included on the label or in the labeling
• Manage labeling changes request initiators to understand requirements, design solutions, timelines and deliverables
• Develop standardized and optimized label templates
• Supports investigations, root cause analysis and corrective action to address labeling non-conformance
• Coordinate with suppliers and vendors for outsourced printed products and translated materials
• Ensure labeling compliance with quality management system (QMS), regulatory requirements and guidelines, standard operating procedures and work instructions
• Coordinate training for manufacturing personnel related to label system operation and maintenance
• Contribute to the development and documentation of business processes to support product labeling
• Coordinate Labelling activities as needed
• Supports investigations, root cause analysis and corrective action to address other type of non-conformance

Qualification requirements :

• Bachelor's or master's degree in a scientific discipline or equivalent
• Minimum 3 years of labeling experience in an FDA or EU regulated environment. Medical device or pharmaceutical industry
• Fluent in English and French
• Experience utilizing label design software such as Easy Label, Nice Label, Bartender, or Adobe Illustrator / Photoshop and other related software
• Basic reading and math
• Knowledge of quality systems and relationship to business

More information on www.baltgroup.com

Quality Engineer • Montmorency, Île-de-France, France