Quality Manager in Alcalá de Henares

Quality Manager (M/F/X) Quality Healthcare (M/F/X) - ISO 15378 - ISO 13485 📍 Location: Alcalá de Henares, Madrid 🌍 International environment | Healthcare Sector | Strategic project Are you passionate about quality in regulated environments and would you like to lead the construction of a quality system from a strategic perspective? We are looking for a Quality Healthcare professional to become the Quality, Regulatory, and Compliance reference for a rapidly growing business unit within the Healthcare sector. What will your mission be? To lead the Quality and Compliance strategy of the Healthcare unit, ensuring compliance with regulatory and normative requirements, as well as the development of processes, systems, and certifications that allow for continued solid and sustainable growth. Main responsibilities ✅ Define and implement the Quality and Regulatory strategy for the business unit. ✅ Lead the development and certification of the Quality Management System, especially under ISO 13485. ✅ Participate in the development and industrialization of new Healthcare products, guaranteeing adequate risk management, validations, and changes. ✅ Act as a technical reference in audits, approvals, and client relations. ✅ Guarantee the qualification of suppliers, raw materials, and critical processes. ✅ Drive the quality culture and best practices in collaboration with Operations, Engineering, Purchasing, Sales, and Product Development. ✅ Identify and manage regulatory and quality risks to ensure compliance with applicable requirements. What are we looking for? ✔ University degree in Engineering, Pharmacy, Chemistry, Biology, Biotechnology, or similar. ✔ Between 5 and 10 years of experience in Quality and/or Regulatory positions within Medical Devices, Pharma, Healthcare Packaging, or highly regulated industries. ✔ Experience in the implementation and management of quality systems under ISO 13485. ✔ Knowledge of validations, risk management, CAPAs, audits, and industrialization processes. ✔ High level of English. ✔ Ability to lead cross-functional projects and influence different areas of the business. What does the project offer? ⭐ Strategic position with a direct impact on business growth. ⭐ Industrial and international environment. ⭐ Participation in high value-added projects within the Healthcare sector. ⭐ High level of autonomy and decision-making capacity. ⭐ Opportunity to define and drive the quality model of an expanding business unit. If you are looking for a challenge where you can combine strategic vision, leadership, and real impact in a growing organization, we will be delighted to meet you.