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 to detail.
Experienc

📌 Quality Affairs Specialist (Barcelona)
🏢 Aortyx
📍 Barcelona