- Ensure products developed by Biokit meet all Quality requirements and comply with applicable regulations
- Provide quality oversight for development and commercialization of new assay products and post-commercialization design changes
- Provide Design Control and Design Change Control guidance, including risk management and regulatory strategies
- Ensure assays comply with the Product Development process, Biokit Quality System, and worldwide design control regulations
- Prepare documentation supporting worldwide regulatory submissions, product risk management, and design history
- Collaborate with R&D;, Quality Operations, Regulatory Affairs, and Operations to meet project goals and complete regulatory submissions
- Apply a risk-based approach to validation and implementation of product changes
- Provide Quality Oversight to non-conformance investigations, root cause investigations, and CAPA
- Ensure documentation is QA reviewed before sharing with regulators or customers
- Lead continuous improvement of DQ processes, standards, tools, and techniques




- Design and deliver training on design control
- Collaborate with QRA, R&D;, and Operations for successful Regulatory Inspections

Requirements
- Bachelor's degree (Diplomatura) in Life Sciences, Engineering, or Physical Science; relevant skills and work experience may substitute for the degree
- Minimum of 3 years in a similar position
- Fluency in Office Tools (Excel & Word)
- Basic knowledge in SAP is valuable
- Fluency in Spanish or Catalan
- Advanced knowledge of English (reading and speaking)
- Knowledge of Quality standards, including design control and validation
- Certifications such as ASQ–CQA, ASQ-CQE, ASQ-SWQE, ASQCQM, Process Excellence are valuable
- Ability to manage decisions under pressure
- Methodical and well-organized
- Time management skills
- Ability to express information clearly and concisely
- Ability to apply a systematic approach and control, follow up, and verify results
- Ability to collabo

📌 Design Quality Engineer (Llissá de Munt)
🏢 Jobtailor
📍 Llissá de Munt