Design Quality Engineer
8 days ago
Lliçà d'Amunt
• 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, • 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 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. • Quality Oversight, • Design Control, • Regulatory Compliance, • Risk Management, • Continuous Improvement, • Quality Standards, • Design Change Control, • Validation, • Regulatory Submissions, • Documentation Preparation, • Root Cause Investigation, • CAPA, • Project Management, • Assay Development, • Product Risk Management, • Time Management, • Methodical Organization, • Clear Communication, • Collaboration, • Decision-Making Under Pressure, • ASQ–CQA, • ASQ-CQE, • ASQ-SWQE, • ASQCQM, • Process Excellence, • Biokit Quality System, • Worldwide Design Control Regulations, • Non-Conformance Investigations, • Regulatory Inspections, • Assay Products, • Office Tools, • Excel, • Word, • SAP #J-18808-Ljbffr