Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain.
Our Headquarters are in Barcelona, Spain and our Technology Centers are located in the United States and Europe. Worldwide sales exceeded €2.2 billion in 2024, and our workforce is more than 7,000 strong.
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.
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 Quality Oversight to non-conformance, root cause investigations and CAPA.
Ensures that all documentation is QA reviewed before it is shared externally with regulators and/or customers.
Designs and delivers appropriate training to develop the overall competency of the organization regarding design control.
Networking / Key Relationships
Bachelor's degree (Diplom

📌 Design / Quality Engineer (España)
🏢 Actual Talent
📍 España