Aortyx is looking for Jr. and Sr. Quality Affairs Specialists (m/f) to work full-time, on-site, in Esplugues de Llobregat, Barcelona.

Main tasks and responsibilities
- Assist in the maintenance and continuous development of the quality management system (QMS) according to ISO 13485 and FDA requirements.
- Author, review, and monitor new and existing QMS procedures and processes.
- Interact with external quality affairs consultants and testing laboratories.
- Support all internal and external audits, including preparation and execution of Notified Body audits.
- Lead QMS projects, including creating and maintaining internal audit schedules and records, and tracking CAPA activities as required.
- Support other areas from the quality assurance perspective.
- Support the daily activities of the quality department.

The role involves supporting, maintaining, and improving the company’s quality management system in alignment with regulatory and industry standards. Day-to-day activities include drafting, reviewing,



and updating quality procedures and documentation; coordinating internal audits and follow-up actions; and supporting risk management and corrective/preventive actions. The role also involves collaborating with cross-functional teams to ensure quality requirements are integrated into product development and manufacturing as well as preparing and maintaining records needed for regulatory submissions and inspections.

Qualifications

EDUCATION
- Bachelor's degree in life sciences, engineering, or a related field.
- Advanced degree (e.g., Master's, PhD) is preferred.

SKILLS
- Strong knowledge of quality management systems and applicable regulations or standards (e.g., ISO 13485), with experience implementing and maintaining quality frameworks in a regulated environment.
- Proficiency in documentation control, audit preparation, and quality reporting, including the ability to create, review, and manage procedures, work instructions, and records with high attention

📌 Quality Affairs Specialist (Barcelona)
🏢 Aortyx
📍 Barcelona