We are a global leader in specialized diagnostics for Hemostasis, Acute Care Diagnostics, Autoimmunity and Transfusion and transplant.
Our Expertise
We research, develop, and manufacture customized assays and biomaterials through our OEM business line. As part of Werfen, a global healthcare company dedicated to delivering the highest quality in vitro diagnostics products.
Quality Systems Engineer Role
We are seeking a Quality Systems Engineer who will ensure the company's compliance with all applicable regulations and standards. This individual will be responsible for organizing external and internal audits, participating in continuous improvement initiatives, and leading the document management system.
Key Responsibilities
* Ensure company compliance with regulatory requirements
* Organize and conduct audits, including external and internal
* Participate in the continuous improvement of the QRA area
* Lead the document management system and manage changes
* Own and manage the Change Control Management System
Requirements
* Bachelor's degree in Chemistry, Biotechnology or related field
* Competency in chemical, biological, or health-related work experience
* Fluency in Office Tools (Excel & Word) and Adobe tools
* Advanced knowledge of English (reading and speaking)
* Deep knowledge of regulatory requirements in medical devices and/or in-vitro diagnostics
What We Offer
* A meaningful project impacting laboratory medicine worldwide
* Multicultural and friendly team
* Exciting opportunities for professional development
* Ongoing training
* Social benefits: canteen, nursery check, language training...