Product Expert P.05

Description

Job Summary: We are seeking a passionate Product Expert IVD dedicated to transforming quality and safety standards in the healthcare sector, responsible for the evaluation and certification of IVD products. Key Highlights: 1. Part of a solid international business project. 2. A participatory and inclusive work environment with hybrid working models. 3. A dynamic and multicultural team where you can leave your mark. Products In the **Products** business unit at TÜV Rheinland, we are looking for talents who want to stand with us at the forefront of safety, quality, and innovation. Our goal is to make products safe and compliant with standards in international markets – from consumer goods to highly complex medical devices. In doing so, we support companies in complying with national and international standards. Our focus is on the challenges of digitalization, sustainability, and global trade requirements. Whether smart technologies, sustainable materials, or the safety of connected products – we actively shape the future of product safety. ### **Our Core Areas:** * **Softlines:** Testing, inspection, and certification services for textiles, clothing, footwear, leather goods, and other consumer products. * **Hardlines:** Safety and quality testing for household goods, toys, furniture, sports equipment, tools, and DIY products. * **Electrical:** Testing and certification of electrical and electronic products, from household appliances to industrial control systems. * **Solar \& Commercial:** Quality assurance and certification of photovoltaic modules, inverters, and commercial technical installations. * **Medical:** Comprehensive testing and certification for medical devices, from diagnostic equipment to implants, including regulatory consulting. **Join a Strong Team!** ----------------------- At TÜV Rheinland, you can contribute and expand your expertise in an international environment. We offer a dynamic work environment that fosters innovation, embracing diversity and continuous learning. Together, we shape a future where safety and quality go hand in hand. The TÜV Rheinland Group, as a sustainable and independent provider of testing, inspection, certification, consulting, and training, has been a global leader in quality and safety assurance for over 150 years and employs more than 24\.000 people. **Location:** Barcelona or Madrid. **The Role:** We are seeking a qualified and passionate Product Expert IVD committed to transforming quality and safety standards in the healthcare sector. You will be responsible for the evaluation and certification of IVD products, applying your technical and regulatory knowledge to ensure compliance with applicable regulations. **Key Responsibilities:** * Evaluate complex medical devices in accordance with relevant technical regulations and corresponding CE directives, including documentation in compliance with standards. * Review technical documentation / design dossiers for medium-risk medical devices. * Conduct evaluations across several specialized areas depending on the product group and authorization level: + Preparation of medical devices + Packaging and its validation + Qualification and supervision of cleanrooms + Personal and product hygiene + Evaluation of biotechnology- and software-based production processes * Assess fundamental aspects involved in product-related evaluations. * Prepare compliant documentation. * Act as a certifier and/or specialist certifier when required. * Perform other duties assigned. **\#LI\-ES** **Requirements:** * Degree in engineering, sciences, or a related technical field. * Minimum 4 years of experience in development, production, or quality management specifically within the IVD medical device sector. * Fluency in Spanish and English; Portuguese is considered a plus. * Knowledge of ISO 13485, ISO 9001, and sector-specific standards. * Ability to travel both nationally and internationally. **What We Offer:** * Opportunity to join a solid international business project, with professional development opportunities and a strong people-oriented approach. * Job stability with an indefinite full-time contract. * A participatory and inclusive work environment implementing hybrid working models combining office and remote work. * Access to a flexible remuneration package with tax advantages, competitive at market level, and performance-based bonuses tied to goal achievement and contribution to results. * An individual development plan to enhance professional and personal competencies, supporting talent management and clearly defined career paths, with clear milestones and associated salary reviews. * A dynamic and multicultural team where you can leave your mark. If you are ready to take on new challenges and wish to join a company where your work makes a difference, apply today to become our next Product Expert IVD! ### **Diversity \& Inclusion** Equal opportunities are particularly important to us at TÜV Rheinland. We are committed to breaking down barriers and creating an inclusive working environment characterised by respect, diversity and genuine participation. We therefore particularly welcome applications from people with severe disabilities.