- 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 InspectionsRequirements- 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 collaborate, participate, and coordinate actively with working groupsCore CompetenciesDemonstrates expertise in Quality Oversight, Design Control, and regulatory compliance for assay products, with a strong focus on risk management and continuous improvement processes. Proficient in collaborating across departments to ensure successful regulatory submissions and adherence to quality standards.Highest-signal resume keywords- Quality Oversight- Design Control- Regulatory Compliance- Risk Management- Continuous ImprovementHard Skills- Quality Standards- Design Change Control- Validation- Regulatory Submissions- Documentation Preparation- Root Cause Investigation- CAPA- Project Management- Assay Development- Product Risk ManagementSoft Skills- Time Management- Methodical Organization- Clear Communication- Collaboration- Decision-Making Under PressureCertifications & Qualifications- ASQ–CQA- ASQ-CQE- ASQ-SWQE- ASQCQM- Process ExcellenceIndustry Keywords- Biokit Quality System- Worldwide Design Control Regulations- Non-Conformance Investigations- Regulatory Inspections- Assay ProductsTools & Technologies- Office Tools- Excel- Word- SAP#J-18808-Ljbffr

📌 Design Quality Engineer (España)
🏢 Jobtailor
📍 España