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 collaborate, participate, and coordinate actively with working groups Core Competencies Demonstrates 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 Improvement Hard Skills Quality Standards Design Change Control Validation Regulatory Submissions Documentation Preparation Root Cause Investigation CAPA Project Management Assay Development Product Risk Management Soft Skills Time Management Methodical Organization Clear Communication Collaboration Decision-Making Under Pressure Certifications &

Qualifications ASQ–CQA ASQ-CQE ASQ-SWQE ASQCQM Process Excellence Industry Keywords Biokit Quality System Worldwide Design Control Regulations Non-Conformance Investigations Regulatory Inspections Assay Products Tools & Technologies Office Tools Excel Word SAP

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