Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Overview

The position is responsible for ensuring that products developed by Biokit meet all Quality requirements and are documented in compliance with all applicable regulations. The position provides quality oversight for the development and commercialization of new assay products in addition to post commercialization design changes for assays.

Responsibilities

Key Accountabilities
- Provide Design Control / Design Change Control guidance to internal or external product development teams,



including risk management and development of regulatory strategies and plans.
- The role will ensure that assay developed by Biokit in compliance with the Product Development process & Biokit Quality System and worldwide design control regulations.
- Key outputs include: documentation to support efficient worldwide regulatory submissions, product risk management, and comprehensive design history.
- Ensure effective partnering and collaboration with R&D;, Quality Operations, Regulatory Affairs and Operations to meet project goals, maintain compliance, and complete defined regulatory submissions.
- Partner with the R&D; teams ensuring a risk-based approach to the validation and implementation of product changes to existing products while maintaining compliance with Quality System elements, including but not limited to: Design Control, Design Change, Risk Management and Change Control.
- Provide Qualit

📌 Design Quality Engineer (Cataluña)
🏢 Werfenlife
📍 Cataluña