Quality Engineer

Description

**LVD Biotech \- iVascular Group** is an international medical technology group specializing in the development, manufacturing, marketing, and distribution of innovative medical devices for the treatment of vascular system pathologies worldwide. Our vertically integrated business model enables us to manage the entire product lifecycle. The group comprises two highly specialized and complementary companies: * LVD Biotech, our innovation hub, leads and drives research and development of new technologies, managing the full product development cycle—from initial concept generation through to regulatory dossier preparation—including knowledge creation and protection via intellectual property. * iVascular transforms this innovation into medical solutions delivered to healthcare professionals and patients through manufacturing, logistics, marketing, and international commercialization of a portfolio of medical devices for Coronary, Peripheral, and Neurovascular applications. With a team of over 600 professionals and commercial presence in more than 86 countries, both companies operate in an integrated, continuously collaborative environment that combines science, innovation, industrial excellence, and the highest quality standards. Together, we drive the development of cutting-edge medical solutions with a shared mission: improving patients’ quality of life worldwide. **Position:** ----------- We are seeking a **QUALITY ENGINEER** to join our Quality team at our facilities located in **Sant Vicenç dels Horts (Barcelona).** Your primary objective will be to ensure that the safety and quality of our products meet all applicable requirements and quality standards prior to market release. To achieve this, you will evaluate, develop, and implement preventive quality measures, in-process controls, and process and raw material robustness enhancements. As a core responsibility, you will also monitor and analyze production and field incident data to identify and resolve issues in the most agile and effective manner possible. **KEY RESPONSIBILITIES** * Management of product quality issues and non-conformities: Ensure proper handling per regulatory and internal requirements; lead investigations; identify root causes; define corrective and preventive actions (CAPA). * Risk analysis: Participate in Process FMEAs, design reviews, and risk assessments related to non-conformities. * Quality plans: Ensure correct implementation of product quality plans, process parameters, and raw material specifications. * Materials and suppliers: Evaluate raw material non-conformities; analyze supplier responses; collaborate on supplier audits. * Equipment and processes: Review and approve equipment qualifications and validations; propose improvements to equipment, tooling, and procedures. * Quality management system: Support effective implementation of the QMS, internal audits, document control, traceability, and regulatory compliance. * You will interact internally with all departments and externally with health authorities, official bodies, certification organizations, suppliers, and customers. **Requirements:** --------------- **IDEAL PROFILE** * Bachelor’s or Engineering degree. * Training and experience in ISO 13485, MDR, MDSAP, and 21 CFR. * Over 5 years of relevant experience in a similar role—preferably within the medical device, healthcare products, automotive, metallurgical, or mechanical-electronic industries—as a Quality and/or Production Engineer. * Advanced written and spoken English proficiency. A language assessment will be conducted. * Analytical, proactive, solution-oriented, rigorous, and well-organized individual with strong communication and interpersonal skills, as well as high leadership potential. **Additional Information:** --------------------- **WHAT WE OFFER** * Permanent and stable employment within a globally impactful project currently undergoing international expansion. * Professional and personal development in a young, dynamic environment. * Competitive salary based on experience and an attractive benefits package. * Flexible working hours to support work-life balance. * Flexible compensation (restaurant vouchers, transportation, and childcare vouchers). * Access to the iWellness program: on-site gym and physiotherapy services. * Corporate events and gifts. * Subsidized company cafeteria. Benefit: Health insurance, Flexible working hours, On-the-job training, Language courses, Professional growth opportunities, Free gym access at offices, Subsidized meals, Company events / Team-building activities