Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries ? We are looking for an experienced Quality Assurance & Regulatory Affairs (QARA) professional to support a Medical Device organization. In this role, you will act as an extension of the manufacturer's Quality and Regulatory team, helping to maintain compliance with applicable regulatory and quality standards, including EU MDR 2017/745 , ISO 13485 , ISO 9001 , and ISO 14001 . This is an excellent opportunity for a hands-on quality and regulatory expert who enjoys working in a dynamic MedTech environment and collaborating across multiple stakeholders. Maintain and continuously improve the Quality Management System (QMS). Update quality documentation, procedures, forms, and records. Manage non-conformities, CAPAs, deviations, and change controls.



Support Management Reviews and quality performance monitoring. Assist with supplier quality management. Maintain regulatory documentation for distributed medical devices and support product launches. Degree in Life Sciences, Engineering, Pharmacy, Quality, or a related field. Minimum 3 years of experience in Quality Assurance and/or Regulatory Affairs within the medical device industry. Experience in QMS maintenance, audits, CAPAs, deviations, change controls, and non-conformity management. If successful, a technical interview with the project stakeholders will be arranged. PQE Group offers the opportunity to work on international projects, develop specialized expertise, and collaborate with industry-leading pharmaceutical companies worldwide.

📌 Quality Assurance (Cataluña)
🏢 Pqe Group
📍 Cataluña